Transition Therapeutics Inc.’s TTHI shares plunged 74.1% immediately after the company reported that one of its lead pipeline candidates, ELND005, failed to achieve the primary endpoint in a phase II/III study. ELND005 is being evaluated for the treatment of patients suffering from mild-to-severe Alzheimer’s disease (AD), who experience at least moderate levels of agitation/aggression.
The randomized, double-blind, placebo-controlled study (n=350) was conducted to evaluate the efficacy, safety and tolerability of ELND005 in AD patients over a treatment period of 12 weeks. Results showed that patients when treated with ELND005 witnessed a significant but similar reduction in agitation and aggression levels relative to baseline as measured by the Neuropsychiatric Inventory Clinician scale when compared to placebo, thereby missing the primary endpoint of the study. Moreover, patients in the placebo arm demonstrated a greater-than-expected reduction in agitation and aggression over weeks 4, 8 and 12.
The safety and tolerability profile of the candidate was found to be consistent with earlier studies in AD at the 250 mg dose.
Transition Therapeutics is currently working on data and will decide on the future development path only after consulting an external clinical advisory committee. The company plans to present the data at a medical meeting in the future.
Apart from ELND005, Transition Therapeutics has TT401 (LY2944876) in its pipeline. TT401 is in phase II development for the treatment of type II diabetes and obesity. The company has a collaboration agreement with Eli Lilly LLY for TT401.
We note that the successful development of therapies for the treatment of AD is challenging and several large pharmaceuticals companies including Eli Lilly have faced setbacks. However, companies like Biogen BIIB are looking to bring AD treatments to the market.
Transition Therapeutics currently carries a Zacks Rank #4 (Sell). Gilead Sciences Inc. GILD is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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