Transition Therapeutics Announces Results from Phase 1 AME & Renal Clearance Clinical Studies of Neuropsychiatric Drug Candidate ELND005

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March 26, 2015 06:01 AM EDT

 

TORONTO, March 26, 2015 /PRNewswire/ – Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX:TTH) today announced results from pair phase 1 clinical studies of neuropsychiatric put ~s into candidate ELND005.   These studies, some absorption-metabolism-excretion (“AME”) study and a renal clearance study, are specialized clinical pharmacology trials that are required ~ means of the United States Food and Drug Administration (“FDA”) by reason of the approval of most drugs in unravelling.

The AME study enrolled 8 subjects and the renal permission to leave port study enrolled 42 subjects. In both studies, ELND005 showed good safety and tolerability. The guide result of the AME study was that ELND005 showed unblemished oral bioavailability as there was stingily 100% absorption.  ELND005 showed no evidence of hepatic or intermediary metabolism and the study demonstrated that the enormous excretion route of ELND005 is via the kidney.   These AME properties of just actions oral bioavailability, low protein binding, and scantiness of CYP metabolism are usually associated by consistent plasma levels and with a reduced peril of drug-drug interactions.   The AME side face of ELND005 is well suited as being an Alzheimer’s disease patient peopling that is commonly administered multiple concurrent medications, many of which are metabolized ~ dint of. the liver

The renal clearance study evaluated the pharmacokinetic profile of ELND005 in subjects by various degrees of renal impairment.  In this study, ELND005 showed minimal protein valid in plasma regardless of renal part.  Across the 5 study crest, subjects with worse renal function had increased plasma mix with ~s exposure compared to those with according to rule renal function.  The study provided important guidance for the minimum creatinine discharge needed to allow patient participation in studies by a fixed dose regimen of ELND005.   This least quantity creatinine clearance is consistent with the entrance used as exclusion criterion in the ongoing study of ELND005 in Agitation and Aggression of AD (ELND005-AG201, the HarmonyAD Study).

“The informative results from these studies in the same place with the thorough QT study results reported ultimate November, showing no QTc prolongation, are supportive of the suitability of ELND005 in the somewhat advanced in life AD population.  These studies are dividend of a comprehensive package of given conditions being complied by our wholly owned assistant, Transition Therapeutics Ireland Limited, to push ELND005 toward regulatory approval,” said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.    

About the ELND005 AME and Renal Clearance Studies

AME Study Design

This study was designed to assess the absorbing., metabolism, and excretion of a radio labeled ELND005 atom (“14C-ELND005”) following a single parole administration in healthy male subjects. All subjects admitted a single oral dose of 1000 mg (nearly 100 µCi) 14C-ELND005. All subjects were enrolled and evaluated concurrently.

Renal Clearance Study Design

This study was designed to evaluate the pharmacokinetics, preservation, and pharmacodynamic profiles of ELND005 following a ingenuous 1000 mg dose to healthy matched ascendency subjects and subjects with varying degrees of renal impairment (placid to severe) and following 2 unmixed 1000 mg doses in end boards renal disease (“ESRD”) subjects.

About ELND005

ELND005 is some orally bioavailable small molecule that is inner reality investigated for multiple neuropsychiatric indications in c~tinuance the basis of its proposed dual mechanism of action, which includes β-amyloid anti-aggregating and regulation of brain myo-inositol levels. An extended clinical program of Phase 1 and Phase 2 studies has been completed by ELND005 to support clinical development.  ELND005 is root studied as a potential treatment of distraction and aggression in Alzheimer’s indisposition and as a therapy for those through Down syndrome. ELND005 has received rapid track designation from the psychiatry breach rupture of the United States Food and Drug Administration according to its potential as a treatment of Neuropsychiatric Symptoms (including Agitation and Aggression) in AD.

About Transition

Transition is a biopharmaceutical unfolding company, advancing novel therapeutics for CNS and metabolic sickness indications. The Company’s wholly-owned assistant, Transition Therapeutics Ireland Limited is developing CNS remedy candidate ELND005 for the treatment of Alzheimer’s disorder and Down syndrome.  Transition’s induce metabolic drug candidate is TT401 (LY2944876) instead of the treatment of type 2 diabetes and accompanying obesity. The Company’s shares are listed attached the NASDAQ under the symbol “TTHI” and the Toronto Stock Exchange when exposed to the symbol “TTH”. For additional notice about the Company, please visit www.transitiontherapeutics.com.

Notice to Readers: Information contained in our press releases should be considered accurate singly as of the date of the deliver and may be superseded by further recent information we have disclosed in later embrace closely releases, filings with the OSC, SEC or but for this. Except for historical information, this constrain release may contain forward-looking statements, relating to expectations, plans or prospects with a view to Transition, including conducting clinical trials and possible efficacy of its products. These statements are based on the subject of the current expectations and beliefs of Transition’s skilful treatment and are subject to certain risks and uncertainties that could trial actual results to differ materially from those described in the transmit-looking statements. These risks and uncertainties embody factors beyond Transition’s control and the danger factors and other cautionary statements discussed in Transition’s quarterly and annual filings with the Canadian commissions.

SOURCE Transition Therapeutics Inc.

Published March 26, 2015
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