Biotechnology Events

Home

Transition Therapeutics, Inc.

Partner : Elan Corporation

.

Transition Therapeutics’ ELND005 Showed No Prolongation of QT Interval
TORONTO, ON, November 24
th, 2014 – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX:TTH) today announced results from a thorough QT (tQT) study in which no QT effects were observed at supra-therapeutic single doses of neuropsychiatric drug candidate, ELND005. A tQT study is a specialized clinical trial required by the United States Food and Drug Administration (“FDA”) for the approval of most drugs in development. Transition’s wholly-owned subsidiary, Transition Therapeutics Ireland Limited (“TTIL”) presented the tQT study data at the Clinical Trials in Alzheimer’s Disease conference on November 21, 2014.

From a safety perspective, drugs that have no QT prolongation effects are particularly desirable for administration to an elderly Alzheimer’s disease (“AD”) population. AD patients are especially challenging for novel drug development, since they typically have multiple medical co-morbidities and receive multiple medications. The use of some antipsychotics and anti-depressants may increase the risk of QT prolongation, arrhythmias, and sudden death in AD patients.

Single doses, 2000mg and 7000mg of ELND005, appeared to be safe and well-tolerated by healthy subjects in this study. ELND005 exposures in this study are five-fold higher than the loading dose of 1000mg BID in the current Agitation and Aggression in AD clinical study (AG201). These ELND005 doses did not have any clinically relevant effects on electrocardiogram (“ECG”) parameters and the study represents a clearly negative thorough QT (tQT) study.
More
Source: press release, 11/24/14. http://transitiontherapeutics.com/media/press_releases/20141124.pdf

.

Agitation and Aggression in AD: Transition has reviewed all the Agitation and Aggression data from the previously completed phase 2 trials in mild to moderate Alzheimer's Disease (AD201 and AD251), as well as all of the blinded data from the large ongoing ELND005 clinical trials of Agitation and Aggression (AG201 and AG251). Based on this in-depth review and analysis, Transition is fully committed to allocating all the financial and human resources necessary to support the Phase 2 study evaluating ELND005 in mild to severe Alzheimer's disease patients who are experiencing agitation and aggression. This ongoing clinical study (AG201) is called the "Harmony AD" study (www.harmonyadstudy.com) and has a projected enrollment of up to 400 subjects. Transition expects enrollment to be completed by the first quarter of 2015 with results from the study expected in mid-2015. A safety extension study (Study "AG251") is ongoing and is enrolling subjects who have completed the placebo-controlled "HarmonyAD" study. To date, the large majority of subjects completing the "HarmonyAD" study are participating in the AG251 extension study. This Agitation and Aggression in AD program has received fast track status from the United States Food and Drug Administration.
More
Source: press release, 4/07/14. http://transitiontherapeutics.com/media/news.php

.

Dr. Tony Cruz, Chief Executive Officer, commented on the timing for data from the phase-II trial with ELND-005 in AD. He stated, "Aggression in Alzheimer's patients is considered a major problem for caregivers and a major cost for the health care system. It is the major reason why AD patients or Alzheimer's patients are institutionalized. The 400-patient aggression trial is a placebo-controlled safety and efficacy study with primary endpoints being severity of aggression following a 12-week trial or 12 weeks of treatment. According to clinicaltrials.gov, the efficacy trial is expected to be completed by the end of the year."
Source: Q3 FY 2013 earnings conference call, 5/07/13.

.

Transition Therapeutics Announces Enrollment of the First Patient in Phase 2 Study of ELND005 (Scyllo-inositol) for the Treatment of Agitation/Aggression in Patients with Alzheimer's Disease

- Approximately 90% of AD patients develop neuropsychiatric symptoms
- Approximately 60% of AD patients develop agitation/aggression

TORONTO, ON, November 28th, 2012 - Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) today announced its licensing partner, Elan Corporation, plc ("Elan") has enrolled the first patient in a Phase 2 study of ELND005 (Study AG201) for the treatment of agitation/aggression in patients with moderate to severe Alzheimer's disease (AD).

The objectives of Study AG201 are to evaluate the efficacy, safety and tolerability of ELND005 over 12 weeks of treatment in patients with moderate to severe AD, who are experiencing at least moderate levels of agitation/aggression. The study is expected to enroll approximately 400 patients at multiple sites in the US, Canada and potentially other selected regions. In the Phase 2 AD Study (AD201), ELND005 appeared to decrease the emergence and severity of specific neuropsychiatric symptoms, an effect which seemed to correlate with drug exposure for some symptoms. ELND005 also led to a sustained reduction of brain Myo-inositol levels that are thought to play a role in phospho-inositol signaling pathways and synaptic activity. More information on Study ELND005-AG201 will be available at http://www.clinicaltrials.gov/.
More
Source: press release, 11/28/12. http://www.transitiontherapeutics.com/media/news.php

.

ELND005 (AZD-103) for Alzheimer's Disease

Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.

The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL) in mild to moderate patients. The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 2/09/12. http://www.transitiontherapeutics.com/media/news.php

.

ELND005 (AZD-103) for Alzheimer's Disease

Transition's lead Alzheimer's disease compound ELND005 (AZD-103) is a disease modifying agent with the potential to both prevent and reduce disease progression, and improve symptoms such as cognitive function.

The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL) in mild to moderate patients. The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 9/19/11. http://www.transitiontherapeutics.com/media/news.php

.

The recently completed Phase II study was a randomized, double-blind, placebo-controlled, safety and efficacy study of ELND005 (AZD-103) in approximately 340 patients with mild to moderate Alzheimer's disease. The study evaluated both cognitive and functional endpoints, and each patient's participation lasted approximately 18 months. Elan and Transition announced topline summary results of the Phase II study and plans for Phase III for ELND005 (AZD-103). The AD201 study did not achieve significance on co-primary outcome measures (NTB and ADCS-ACL). The study identified a dose with acceptable safety and tolerability. The dose demonstrated a biological effect on amyloid-beta protein in the cerebrospinal fluid and effects on clinical endpoints in an exploratory analysis. Based on the preponderance of evidence, and input from the experts in this field, the companies intend to advance ELND005 (AZD-103) into Phase III studies.
Source: press release, 5/10/11. http://www.transitiontherapeutics.com/media/news.php

.

TORONTO, Dec. 27, 2010 -- Transition Therapeutics Inc. ("Transition" or "Company") (TSX:TTH) (Nasdaq:TTHI) today announced that the Company and Elan Corporation, plc ("Elan") (NYSE:ELN) have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.
Source: press release, 12/27/10. http://www.transitiontherapeutics.com/news/article.php

.

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Efficacy and Safety Study of Oral ELND005 for Treatment of Agitation and Aggression in Patients With Moderate to Severe Alzheimer's Disease
Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
More
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01735630?term=ELND005&rank=4

Compound/DeviceSpecialtyIndicationCompound ClassTarget
ELND-005 (AZD-103) AlzheimerNeurologyAlzheimers DiseaseBeta-amyloid and myo-inositol modifying agentBeta-amyloid and myo-inositol

Mechanism of action: ELND-005 (AZD-103), a SM, significantly reduce both beta-amyloid and myo-inositol levels in the brain leading to the break down of neurotoxic fibrils, allowing amyloid peptides to clear the body rather than form amyloid plaques and also regulating myo-inositol-dependent neuronal signalling. This limits disease progression and improves symptoms such as cognitive function.

Phase of Development: II

Event Type: Data: Phase II trial results

Dates: 2015-06-01 - 2015-07-31

Results: Pending