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Rigel Pharmaceuticals, Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Raul R. Rodriguez, President and CEO, commented on phase-III trials for Fostamatinib for ITP. He stated, “We put tremendous effort into increasing the speed and efficiency of enrolling patients in the phase-III clinical trials for ITP. We achieved full enrolment in the first study January and the second study is close to full enrolment. We expect to have results from the first study in the middle of 2016 with results from the second study to follow. Also in 2015, we made significant headway of preparing the preclinical PK and CMC sections of the NDA to facilitate filing it with the FDA in early 2017."
Source: Q4 2015 earnings conference call, 3/08/16.

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Rigel Completes Enrollment of FIT Phase 3 Program for Fostamatinib in ITP

SOUTH SAN FRANCISCO, Calif., April 1, 2016 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced it has completed enrollment for both studies in the FIT Phase 3 clinical program of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, in immune thromboycytopenic purpura (ITP). The first study in this program completed enrollment at the end of January and the second study has now completed enrollment. The results from the first study are expected in the middle of 2016, with the results for the second study expected shortly thereafter.

Earlier this year Rigel initiated a Phase 2 clinical trial in a second autoimmune disorder of the blood, autoimmune hemolytic anemia (AIHA). The purpose of this clinical trial is to evaluate the safety and efficacy of fostamatinib in patients with chronic AIHA. This disorder affects an estimated 40,000 Americans, for whom no approved treatment options currently exist.
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Source: press release, 4/01/16. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=2152411

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Rigel Completes Enrollment of First Phase 3 Study of Fostamatinib in ITP (FIT)

SOUTH SAN FRANCISCO, Calif., Jan. 28, 2016 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) today announced that the first of two Phase 3 clinical studies of fostamatinib in immune thrombocytopenic purpura (ITP) completed patient enrollment this month. The results from this first study are expected in the middle of 2016, with the results from the second study expected shortly thereafter.

The FIT program consists of two identical studies of 75 patients each. The patients will have been diagnosed with persistent or chronic ITP, and have blood platelet counts consistently below 30,000 per microliter of blood. Study subjects remain on treatment for 24 weeks. The primary efficacy endpoint of this program is a stable platelet response by week 24 with platelet counts at or above 50,000 per microliter of blood for at least four of the final six qualifying blood draws. For additional information about the FIT studies, visit http://tinyurl.com/RigelPhase3ITP.

Fostamatinib and ITP
In patients with ITP, the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. ITP patients can suffer extraordinary bruising, bleeding and fatigue as a result of low platelet counts. Current therapies for ITP include steroids, blood platelet production boosters (TPOs) and splenectomy. Rigel believes that fostamatinib may address the autoimmune basis of the disease.

The U.S. Food and Drug Administration has granted Orphan Drug designation to fostamatinib for the treatment of patients with ITP. For additional information about ITP, visit http://www.rigel.com/index.php/pipeline/fostamatinib-itp/.
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Source: press release, 1/28/16. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=2133064

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Raul R. Rodriguez, President and CEO, commented on phase-III trials for fostamatinib for ITP. He stated, “We are driving the enrollment of our phase 3 clinical trials in ITP. One of the studies is already more than 75% enrolled, and we are expecting to have top line data from that study in the middle of 2016, and data from the second study shortly thereafter. In the meantime, teams here at Rigel are preparing the NDA application that will follow. As you may know, in September, the FDA granted our request for orphan drug designation for fostamatinib for the treatment of ITP.”
Source: Q3 2015 earnings conference call, 11/03/15

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Fostamatinib in ITP Phase 3 Clinical Program Update

Following a detailed review of the forecasted enrollment figures, Rigel now expects topline data from both Phase 3 clinical trials in the middle of 2016. Rigel is actively working with the clinical sites and investigators to increase patient enrollment through expanded patient outreach, patient advocacy organizations and social media campaigns. In addition, Rigel is expediting the opening of new sites worldwide. Rigel still expects to file the U.S New Drug Application (NDA) for fostamatinib in ITP by the end of 2016.
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Source: press release, 5/07/15. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=2045691

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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura

Enrollment: 75
Study Start Date: May 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT02076399?term=fostamatinib&rank=1...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Fostamatinib disodium (R788) ITPAutoimmune DiseaseIdiopathic thrombocytopenic purpura (ITP)Syk kinase inhibitorSyk kinase

Mechanism of action: Fostamatinib disodium (R788), a SM-inhibitor, disrupts IgG receptor signaling in macrophages and B-cells that is known to promote swelling and the inflammatory response via syk kinase inhibition.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-06-01 - 2016-07-31

Results:

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Rigel's Fostamatinib Meets Primary Endpoint in Phase 3 Study in Chronic ITP

Conference call and webcast today at 8:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., Aug. 30, 2016 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, met the primary endpoint in the first of two double-blind studies in the FIT Phase 3 clinical program for the treatment of adult chronic/persistent immune thrombocytopenia (ITP). The study (n=76) showed that 18% of patients receiving fostamatinib achieved a stable platelet response compared to none receiving a placebo control (p=0.0261). A stable platelet response was defined as achieving greater than 50,000 platelets per uL of blood on at least four of the last six scheduled visits between weeks 14 and 24 of treatment. The results from the second FIT Phase 3 study are expected in October/November 2016.

The most frequent adverse events were gastrointestinal-related, and the safety profile of the product was consistent with prior clinical experience, and no new or unusual safety issues were discovered.

"These data demonstrate the potential benefit of fostamatinib for chronic ITP patients who are in need of new treatment options," said Raul Rodriguez, president and chief executive officer of Rigel. "We believe that fostamatinib has significant commercial potential given that it has a unique mechanism of action that may work where other products have failed."

"We are very encouraged by these results," said Anne-Marie Duliege, M.D., executive vice president and chief medical officer of Rigel. "Consistent with the prior clinical study of fostamatinib in ITP, this FIT Phase 3 study demonstrated that fostamatinib provided a robust and enduring benefit for those patients who responded to the drug candidate."

Patients who met the primary endpoint of this study typically had an increase in platelet counts to a level above 50,000/uL within the initial weeks of treatment, providing early feedback as to whether it was a viable option for treating their ITP.

In general, the clinical goal of ITP treatment is to raise platelet counts to more than 50,000/uL. Patients who met the primary endpoint in this study had their platelet counts increase from a median of 16,000/uL at baseline to a median of more than 100,000/uL at week 24, a robust response that potentially allows patients to remain above 50,000/uL more consistently.

All of the patients from this study who met the stable platelet response endpoint enrolled in the long-term, Phase 3 extension study and continued to maintain their platelet levels for months past the initial study period of 24 weeks. These data affirm similar results observed in two patients from the Rigel Phase 2 study of fostamatinib in ITP who have been taking fostamatinib for more than seven years and have maintained stable platelet levels over this extended time period.

Fostamatinib's clinical safety profile includes more than 5,000 patient years of data across multiple autoimmune indications and has a well-defined and manageable safety profile, providing data that it may be suitable for long-term maintenance therapy in chronic ITP.

If these results are reproduced in the second Phase 3 study and are supported by the results of a planned interim analysis of the Phase 3 extension study, the company expects to submit a New Drug Application with the U.S. Food and Drug Administration in the first quarter of 2017. Further results from the FIT Phase 3 studies and long-term extension will be presented at future medical meetings.
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Source: press release, 8/30/16. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=2198145

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