Early yesterday morning, Transition Therapeutics Inc. (TTHI) and partner Elan Corp. Plc (ELN) announced phase I data on ELND005, which is being developed for the treatment of Alzheimer’s disease (AD). Results showed that ELND005 achieves desired concentrations in human brain tissue and cerebrospinal fluid when administered orally.
The companies also presented preclinical data which showed that ELND005 is associated with preservation of choline acetyltransferase (ChAT). This indicates the preservation of nerve cells that are critical to memory function in the brain. These results were presented at the 2009 Alzheimer’s Association International Conference on Alzheimer’s Disease.
ELND-005 is part of an emerging class of disease-modifying drugs that have the potential of reducing disease progression as well as improving symptoms like cognitive function. ELND-005 breaks down neuro-toxic fibrils, allowing amyloid peptides to clear the brain rather than form amyloid plaques, a hallmark pathology of AD.
ELND-005 is currently in a randomized, double-blind, placebo-controlled, dose-ranging, phase II study (n=340) that will evaluate its safety and efficacy for the treatment of mild-to-moderate Alzheimer’s. Results from the study should be available around the second quarter of calendar year 2010.
The market for Alzheimer’s is huge. It is estimated that more than 5 million people are suffering from the disease in the U.S. Currently approved treatments include Forest’s (FRX) Namenda, J&J’s (JNJ) Razadyne, Novartis’ (NVS) Exelon and Pfizer’s (PFE) Aricept.
However, most of the approved therapies cannot cure or halt the disease and only offer modest improvement in some people. Therefore, the need for a drug that can halt or reverse the disease is immense.
ELND-005 enjoys fast-track status in the U.S. We await more data on ELND-005 from the ongoing phase II clinical trial before recommending the shares. An interim look at the results from this study could be available around early Fall 2009, when the company will make a go / no-go decision regarding phase III development of the candidate. We maintain our Hold rating on Transition Therapeutics with a $5 target.
Read the full analyst report on “TTHI”
Read the full analyst report on “ELN”
Read the full analyst report on “FRX”
Read the full analyst report on “JNJ”
Read the full analyst report on “PFE”
Read the full analyst report on “NVS”
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