Transition announces positive results from ELND005 AME and renal clearance studies

Transition Therapeutics Inc. (“Transition” or the “Company”) (NASDAQ: TTHI, TSX:TTH) today announced results from couple phase 1 clinical studies of neuropsychiatric physic candidate ELND005. These studies, an absorbing.-metabolism-excretion (“AME”) study and a renal clearance study, are specialized clinical pharmacology trials that are required ~ the agency of the United States Food and Drug Administration (“FDA”) for the approval of most drugs in progression in a continuously ascending gradation.

The AME study enrolled 8 subjects and the renal discharge study enrolled 42 subjects. In the two studies, ELND005 showed good safety and tolerability. The elucidation result of the AME study was that ELND005 showed convenient oral bioavailability as there was intimately 100% absorption. ELND005 showed no evince of hepatic or intermediary metabolism and the study demonstrated that the the greater part excretion route of ELND005 is via the kidney. These AME properties of able oral bioavailability, low protein binding, and need of CYP metabolism are usually associated by consistent plasma levels and with a reduced exposure to harm of drug-drug interactions. The AME side face of ELND005 is well suited in quest of an Alzheimer’s disease patient people that is commonly administered multiple conjoined medications, many of which are metabolized ~ the agency of the liver.

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The renal permission to sail study evaluated the pharmacokinetic profile of ELND005 in subjects by various degrees of renal impairment. In this study, ELND005 showed minimal protein band in plasma regardless of renal discharge. Across the 5 study arms, subjects through worse renal function had increased plasma unsalable article exposure compared to those with natural renal function. The study provided significant guidance for the minimum creatinine exoneration needed to allow patient participation in studies through a fixed dose regimen of ELND005. This least part 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 union with the thorough QT study results reported finally November, showing no QTc prolongation, are supportive of the suitability of ELND005 in the elderly AD population. These studies are concern of a comprehensive package of data being complied by our wholly owned subsidiary, Transition Therapeutics Ireland Limited, to send ELND005 toward regulatory approval,” said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.


Transition Therapeutics Inc.

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