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Partner : Eli Lilly

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Incyte Achieves $50 Million Milestone as Oral JAK1/JAK2 Inhibitor Baricitinib Advances into Phase III Development for Rheumatoid Arthritis

WILMINGTON, Del.--(BUSINESS WIRE)--Nov. 15, 2012-- Incyte Corporation (NASDAQ: INCY) announced today that it has earned a $50 million milestone payment from Eli Lilly and Company based on the formal initiation of the rheumatoid arthritis (RA) Phase III program for baricitinib, Incyte’s oral JAK1/JAK2 inhibitor, formerly known as INCB28050. The Phase III program is being conducted by Lilly as part of the exclusive worldwide License, Development and Commercialization Agreement for baricitinib
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Source: press release, 11/15/12. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1...

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RA-BEAM - A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy
Estimated Enrollment: 1280
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01710358?term=Baricitinib&phase=2&...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Baricitinib (INCB-28050) (LY3009104) RARheumatologyRheumatoid Arthritis (RA)Janus-associated Kinase InhibitorsJanus -associated Kinase

Mechanism of action: Baricitinib (INCB-28050) is a SM-inhibitor, reduces inflammation by disrupting the signaling of IL-6, IL-12, and IL-23 through the Janus-associated kinases (JAK) signaling pathway.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2015-07-01 - 2015-09-30

Results:

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Baricitinib Demonstrates Early Response Compared to Placebo and Significant Improvement Compared to Adalimumab in Patient-Reported Outcomes
- Significant improvement in joint pain, severity of morning joint stiffness and tiredness with baricitinib compared to placebo, were seen as early as day 3
- Post-hoc analysis of two phase 3 studies shows significantly improved joint pain, severity of morning joint stiffness and tiredness compared to adalimumab, within 3 weeks of treatment in patients with rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs, including methotrexate
INDIANAPOLIS, Nov. 14, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that in two phase 3 trials, RA-BEAM and RA-BUILD, patients with rheumatoid arthritis (RA) treated with baricitinib experienced significant improvements in patient-reported outcomes, including joint pain, severity of morning joint stiffness and tiredness, compared to placebo and adalimumab (Humira®)*. These findings were presented today at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.
"This analysis looked at important aspects of rheumatoid arthritis such as the pain, morning joint stiffness and tiredness that are common and debilitating symptoms for patients," said Terence Rooney, M.D., Lilly's senior medical director for baricitinib. "Our study results show that treatment with baricitinib rapidly led to significantly greater symptom improvement compared to adalimumab and placebo. The results are very encouraging, and further support baricitinib as a potential oral treatment for those living with RA."
Key findings include:
RA-BEAM
In the RA-BEAM trial, once-daily baricitinib (4 mg) significantly improved joint pain, severity of morning joint stiffness and tiredness, compared to placebo, as early as day 3 and significantly improved duration of morning joint stiffness by day 5. With the same dose of baricitinib, these improvements were significantly greater than adalimumab by day 17 (joint pain), day 19 (severity of morning joint stiffness) and day 21 (tiredness).
In RA-BEAM, compared to placebo, serious adverse events (SAEs) rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups.
The 52-week RA-BEAM study randomized 1,307 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab 40 mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
RA-BUILD
In the RA-BUILD trial, baricitinib (4 mg) significantly improved joint pain, severity and duration of morning joint stiffness and tiredness by days 4, 4, 10 and 3, respectively, compared to placebo.
In RA-BUILD, the incidence of SAEs with baricitinib treatment, including serious infections, was similar to placebo. There were no gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups.
The RA-BUILD study enrolled 684 patients with moderate-to-severe RA who previously had an inadequate response to, or were intolerant of, at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and had not received a biologic DMARD. Patients received either once-daily baricitinib (2 mg or 4 mg) or placebo, in addition to their background therapy.
"Across its pivotal studies, baricitinib has consistently shown significant and rapid improvement of some of the most commonly felt symptoms experienced by patients with RA," said Steven Stein, M.D., chief medical officer, Incyte Corporation. "These data, especially the strong patient-reported outcomes in patients who did not have an acceptable response with their previous conventional synthetic DMARD therapy, underscore previous results and the potential benefits of baricitinib seen in patients with this devastating disease."
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Source: 11/14/16. http://www.incyte.com/ir/press-releases.aspx

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New Analyses of Phase 3 Trials Show Improvements in Rheumatoid Arthritis Symptoms Following Treatment with Baricitinib Across Diverse Population of Patients
Three post-hoc analyses of two phase 3 studies showed improvements in rheumatoid arthritis symptoms in patients irrespective of age, BMI and number of previously used conventional synthetic DMARDs
INDIANAPOLIS, Nov. 14, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced new data analyses of two phase 3 trials, RA-BUILD and RA-BEAM, showing that baricitinib treatment resulted in improvements in rheumatoid arthritis (RA) symptoms across a diverse population of patients with RA regardless of age, body mass index (BMI) and previous treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Findings were presented today at the American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in Washington DC, November 11-16, 2016.
"Multiple patient characteristics may impact the effectiveness of rheumatoid arthritis treatment," said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. "What these data showed is that regardless of a patient's age, body mass index or previous experience with conventional synthetic DMARDs, treatment with baricitinib resulted in improvement in rheumatoid arthritis symptoms. This gives us tremendous hope for how this oral medication may work in a real-world setting, if approved."
Key findings include:
Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating elderly patients found that age did not affect baricitinib's efficacy as measured by ACR20, Health Assessment Questionnaire-Disability Index (HAQ-DI), Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) and Simplified Disease Activity Index (SDAI).

At week 12, in the baricitinib 4 mg group, 67 percent of patients younger than 65 years and 68 percent of patients 65 years or older achieved an ACR20 response, meaning a 20 percent improvement across various aspects of RA. In the group that received placebo, 40 percent of patients younger than 65 years and 43 percent of patients 65 years or older achieved an ACR20 response.
The percentage of patients reporting an adverse event (AE) was higher in patients 65 years or older. The overall rates of AEs, serious adverse events (SAEs), and serious infections were similar between patients treated with placebo and baricitinib in patients younger than 65 years and patients 65 years or older. Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating the effect of baseline BMI on the response to baricitinib in patients who had insufficient response to previous csDMARDs found that baricitinib improved clinical outcomes compared to placebo regardless of baseline BMI as measured by ACR20, ACR50, ACR70, DAS28-CRP, SDAI and Clinical Disease Activity Index (CDAI). The proportion of patients who reached low disease activity or remission, including progression in structural joint damage, improved compared to placebo across the different BMI groups.

Proportion of patients in the low, middle and high BMI groups who achieved an ACR20 response were 68.4 percent, 68 percent and 64.7 percent, respectively. ACR50 and ACR70 responses (meaning a 50 percent and 70 percent improvement across various aspects of RA, respectively) were also improved compared to placebo across the BMI groups. As has been shown for other DMARDs, baricitinib treatment effect for patients with higher BMI was numerically smaller than for patients with lower BMI.
Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
Results from a post-hoc analysis of the phase 3 RA-BUILD and RA-BEAM studies evaluating whether the number of previous csDMARD failures altered patients' response to baricitinib found that baricitinib demonstrated improvement in RA symptoms irrespective of the number of previous csDMARDs used or the present use of oral corticosteroids as measured by ACR20, ACR50, ACR70, radiographic progression, SDAI and DAS28-ESR.

At week 12, in the baricitinib 4 mg groups that previously used methotrexate alone, methotrexate + 1 csDMARD and methotrexate + ≥2 csDMARDs, 67.9 percent, 67.3 percent and 66.9 percent of patients achieved an ACR20 response, respectively. ACR50 responses were also similar across the groups (42.5 percent, 42.9 percent and 39.2 percent, respectively) and ACR70 responses were 21.4 percent, 19.5 percent and 13.3 percent respectively.
The rates of SAEs and discontinuation due to AEs were comparable regardless of the number of csDMARDs used and corticosteroid use. Additional safety information regarding RA-BUILD and RA-BEAM are provided in the study description below.
"These data add to the breadth of evidence supporting baricitinib's efficacy profile across a wide range of patient populations," said Steven Stein, M.D., chief medical officer, Incyte Corporation. "If approved, we believe that baricitinib has the potential to become an effective once-daily oral treatment option for patients with rheumatoid arthritis who may not respond well to other treatments — age, BMI or previous csDMARDs use notwithstanding."
RA-BUILD
The RA-BUILD study enrolled 684 patients with moderate-to-severe RA who previously had an inadequate response to, or were intolerant of, at least one csDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either once-daily baricitinib (2 mg or 4 mg) or placebo, in addition to their background therapy.
In RA-BUILD, the incidence of SAEs with baricitinib treatment, including serious infections, was similar to placebo. There were no gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups.
RA-BEAM
The 52-week RA-BEAM study randomized 1,307 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to once-daily placebo (n=488), once-daily baricitinib 4 mg (n=487) or biweekly adalimumab 40 mg (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
In RA BEAM, compared to placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups.
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Source: press release, 11/14/16. http://www.incyte.com/ir/press-releases.aspx

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Patient-reported outcomes across phase 3 studies of baricitinib demonstrate statistically significant improvements in physical function and quality of life symptoms in patients with rheumatoid arthritis (RA)
Pivotal trials show treatment with baricitinib resulted in significant improvements in pain, fatigue and ability to perform daily activities compared to methotrexate - the current standard of care - and adalimumab (Humira®)*

INDIANAPOLIS, June 9, 2016 /CNW/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that in two phase 3 trials patients with rheumatoid arthritis (RA) treated with baricitinib reported significant improvements in quality of life symptoms and other patient-reported outcomes compared to methotrexate or adalimumab (Humira®). Patients with RA also reported improvement in productivity at work. In these studies, significant improvements in patient-reported measures, including pain, physical function, tiredness and morning joint stiffness, were observed as early as one week after initial treatment with baricitinib. These findings were presented today at the Annual European Congress of Rheumatology (EULAR 2016) in London.
Key findings include:
In the phase 3 RA-BEGIN trial:
At 24 weeks, 81 percent of patients receiving baricitinib monotherapy and 79 percent of patients receiving baricitinib plus methotrexate had clinically meaningful improvement in physical function compared with 70 percent among those receiving methotrexate alone (p < 0.05). Clinically meaningful improvement was defined as an improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score of ≥0.22.
At 52 weeks, 68 percent of patients on baricitinib monotherapy and 72 percent of patients on baricitinib in combination with methotrexate saw clinically meaningful improvements in physical function compared to 57 percent of those treated with methotrexate alone (p < 0.05).
At 24 and 52 weeks, baricitinib (as monotherapy or in combination with methotrexate) was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of the quality of life assessment compared with methotrexate alone.
In the phase 3 RA-BEAM trial, where all patients received background methotrexate therapy:
At 12 weeks, 75 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 71 percent of patients on adalimumab (p=0.302). Clinically meaningful improvement was defined as an improvement in HAQ-DI score of ≥0.22.
At 24 weeks, 73 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 64 percent of patients on adalimumab (p < 0.05).
At 52 weeks, 68 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 58 percent of patients on adalimumab (p < 0.01).
At 52 weeks, baricitinib was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of quality of life compared with adalimumab.
An analysis of the phase 3 trials found that in each study, patients taking baricitinib have less impairment in work productivity and daily activities compared to patients taking the comparator.
"Our extensive phase 3 clinical trial program demonstrates that baricitinib could, if approved, offer a potentially significant improvement in the treatment of rheumatoid arthritis," said Terence Rooney, M.D., medical director, rheumatoid arthritis, Lilly Bio-Medicines. "In these studies, baricitinib demonstrated superiority on a variety of efficacy measures compared to the leading biologic, adalimumab, as well as the current oral standard of care, methotrexate. Additionally, patients reported their personal experience with baricitinib, further highlighting its positive impact on patients' daily lives and activities."
Physical function was measured using the patient-reported HAQ-DI questionnaire that assesses the ability of a patient to perform daily activities like dressing, eating, walking, grip, etc. Quality of life assessment was made by using the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute, or SF-36, which is a patient-reported survey that measures overall health quality based on physical and psychological functioning.
RA-BEGIN demonstrated that in RA patients who had limited or no previous treatment with any disease-modifying antirheumatic drugs (DMARDs), baricitinib used as monotherapy or in combination with methotrexate showed statistically significant improvements in the physical quality of life measures, as measured by the SF-36, when compared to methotrexate alone. Reported improvements in patient quality of life symptoms were accompanied by an increase in physical function, and decreased pain and fatigue. All the improvements with baricitinib were statistically significant at week 24 and week 52, compared to methotrexate alone.
The RA-BEGIN study included patients who had limited or no prior treatment with methotrexate, and were naïve to other conventional or biologic DMARDs. Part of a larger phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEGIN enrolled nearly 600 patients who were randomized to one of the following treatment groups:
Once-weekly oral methotrexate monotherapy
4 mg once-daily oral baricitinib monotherapy
4 mg once-daily oral baricitinib in combination with once-weekly oral methotrexate.
"Left untreated or uncontrolled, rheumatoid arthritis can dramatically impact patients' quality of life," said Steven Stein, M.D., chief medical officer, Incyte Corporation. "Patients and physicians alike deserve better treatment options beyond today's standard of care. If approved, baricitinib has the potential to become an oral drug option that may improve the clinical symptoms of the disease, as well as patients' ability to perform daily activities at home and at work."
The pivotal phase 3 trial, RA-BEAM, showed that RA patients who had previously responded inadequately to methotrexate and were not treated with any biologic, experienced significant improvement in the physical quality of life measures when taking baricitinib compared to patients treated with adalimumab or placebo. Reported improvements in patient quality of life were accompanied by an increase in physical function, and decreased pain and fatigue. The improvements in physical function, pain and physical quality of life with baricitinib were statistically significant at week 24 and week 52, compared to adalimumab.
RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once-daily (n=488), baricitinib 4 mg once-daily (n=487) or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.
In the baricitinib RA development program, no increases in adverse events leading to study drug discontinuation, malignancies, or serious infections were seen for baricitinib vs. placebo or active comparators during the controlled periods of the program. Herpes zoster was reported more frequently for baricitinib vs. placebo. The incidence rates of malignancy, serious infection and herpes zoster did not increase over time including long-term observations.
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Source: press release, 6/09/16. http://www.incyte.com/ir/press-releases.aspx

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Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis
Once-daily oral baricitinib significantly improved all seven components of ACR response versus injectable adalimumab
Patient-reported pain, joint stiffness, fatigue and physical function scores significantly improved with baricitinib compared to adalimumab
Detailed results from pivotal phase 3 study RA-BEAM presented at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting
PR Newswire, Indianapolis, November 7, 2015
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced detailed data from pivotal phase 3 study RA-BEAM, the fourth successful phase 3 study of baricitinib, at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting in San Francisco. The findings demonstrated statistical superiority for investigational therapy baricitinib over adalimumab (Humira®)* after 12 weeks based on several critical measures of rheumatoid arthritis (RA) disease activity, including ACR20, ACR50 and ACR70 response rates — composite scores that represent at least a 20 percent, 50 percent and 70 percent improvement in multiple components of RA disease activity.

Improvements in mean number of swollen and tender joints and a reduction in pain were seen as early as one week for baricitinib versus placebo. At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients’ pain and improving physical function. Patient-reported outcomes, including degree of tiredness and the severity and duration of morning joint stiffness, assessed daily for the first 12 weeks of the study, were all significantly improved with baricitinib compared to adalimumab.

At week 52, structural changes in the joints, as measured by changes in the modified Total Sharp Score, were significantly improved for both baricitinib and adalimumab compared with placebo. Lilly and Incyte previously announced that the study met its primary objective of demonstrating superiority for baricitinib versus placebo based on ACR20 response rate after 12 weeks of treatment.

“Rheumatoid arthritis is a lifelong condition, but it can be managed with treatment to help control symptoms, including joint inflammation and fatigue, to slow the progression of the disease and improve a patient’s quality of life,” said Peter Taylor, M.A., Ph.D., F.R.C.P., study author and Norman Collisson chair of Musculoskeletal Sciences in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. “These findings suggest that the once-daily oral drug baricitinib, if approved, could provide another treatment option for those with insufficient response to current therapy.”

RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once daily (n=488), baricitinib 4 mg once daily (n=487) or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.

“This is the first phase 3 study showing that a once-daily, oral treatment significantly improved clinical outcomes compared with injectable adalimumab for patients with active RA who were also receiving treatment with methotrexate,” said William Macias, M.D., Ph.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. “Lilly is committed to improving outcomes for patients living with this chronic condition.”

Serious adverse event rates were similar for baricitinib compared with placebo and lower for adalimumab, while serious infection rates were similar across groups.** There were no cases of gastrointestinal perforations. One event of tuberculosis was reported, in the adalimumab group. Four deaths occurred, one in the placebo arm, two in the baricitinib arm and one in the adalimumab arm. Two potential opportunistic infections occurred in the baricitinib arm; neither were considered serious. Temporary interruptions in treatment due to adverse events occurred with similar frequency across treatment groups.

“The positive results of the RA-BEAM trial reinforce the potential of baricitinib to quickly improve RA signs and symptoms, physical function and patient-reported outcomes, while inhibiting joint damage,” said Rich Levy, M.D., chief drug development officer, Incyte Corporation. “If approved, this once-daily oral treatment may offer RA patients benefits above those seen with injectable adalimumab.”

Lilly and Incyte announced top-line results in December 2014 for the first phase 3 trial of baricitinib, RA-BEACON; in February 2015 for the second, RA-BUILD; in September 2015 for the third, RA-BEGIN; and in October 2015 for the fourth, RA-BEAM. The companies also will share detailed results from the RA-BEGIN study at the American College of Rheumatology/Association of Rheumatology Health Professionals annual meeting this year, and plan to submit additional detailed data from all four studies for presentation in scientific meetings and publication in peer-reviewed journals in 2016.

Detailed data from the long-term extension study, RA-BEYOND, also will be submitted for presentation in scientific meetings and publication in peer-reviewed journals in 2016.
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Source: press release, 11/07/15. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=2...

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Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study
INDIANAPOLIS, Oct. 14, 2015 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced positive topline results of RA-BEAM, the fourth successful Phase 3 study of baricitinib, an investigational medicine for patients with moderately-to-severely active rheumatoid arthritis.

The study met its primary objective of demonstrating superiority compared to placebo after 12 weeks of treatment based on ACR20 response – a standard clinical measure that represents at least a 20 percent improvement in RA disease activity. Baricitinib was also superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment. Following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. These treatment benefits with baricitinib observed at 12 and 24 weeks were maintained through 52 weeks of therapy.

"RA-BEAM is the first study to demonstrate that a once-daily oral treatment was superior in improving signs and symptoms of rheumatoid arthritis compared to the current injectable standard of care," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines. "If approved, baricitinib could help change expectations for people living with this debilitating disease."

"Combined results of these four Phase 3 studies give us confidence that, if approved, baricitinib could represent a valuable new treatment option for patients with RA," said Rich Levy, M.D., chief drug development officer, Incyte Corporation.

RA-BEAM evaluated the safety and efficacy of baricitinib in patients with active disease despite treatment with methotrexate, compared to placebo for 24 weeks or adalimumab (Humira®)* for 52 weeks. Part of a larger Phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEAM enrolled more than 1,300 patients who were randomized to one of three treatment groups:

4 mg oral once-daily baricitinib on background methotrexate
40 mg injectable every-other-week adalimumab on background methotrexate
placebo on background methotrexate
Compared to placebo, serious adverse events rates were similar for baricitinib and lower for adalimumab; serious infection rates were similar across groups. There were no cases of gastrointestinal perforations. One event of tuberculosis was reported in each of the baricitinib and adalimumab groups. Rates of treatment-emergent adverse events, including infections, were higher for baricitinib and adalimumab compared to placebo. The most common adverse events observed with baricitinib were nasopharyngitis and bronchitis. Discontinuations due to adverse events occurred with similar frequency across treatment groups. A large majority of patients completing this trial opted to participate in a long-term extension study.

Lilly and Incyte announced top-line results in December 2014 for the first Phase 3 trial of baricitinib, RA-BEACON, and in February 2015 for the second, RA-BUILD. Data from these studies were presented at the EULAR annual scientific congress in June 2015. Topline results of the third Phase 3 trial, RA-BEGIN, were announced in September 2015 and will be presented at the American College of Rheumatology annual scientific congress in November. The companies plan to submit detailed data from RA-BEAM and other Phase 3 studies for presentation at scientific meetings and publication in peer-reviewed journals in 2015 and 2016.
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Source: press release, 10/14/15. http://investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=2...

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