Shares of vTv Therapeutics, Inc . VTVT plummeted significantly after the company announced dismal results from the part A of the phase III trial, STEADFAST, on pipeline candidate, azeliragon.
vTv Therapeutics' stock has plunged 50.6% in the last six months as against the industry's decline of 18.9%.
The candidate was being evaluated in patients suffering from Alzheimer's disease. The results showed that the candidate did not meet co-primary efficacy endpoint as patients taking azeliragon versus placebo did not improve in cognitive or functional outcomes as measured by the
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).
The study comprised two independent and identical randomized, double-blind, placebo-controlled phase III trials (part A and part B). The azeliragon treated group in part A showed a 4.4 point decline from baseline in ADAS-Cog and a 1.6 point dip from baseline in CDR-sb compared to a placebo fall of 3.3 and 1.6, respectively. However, these differences were not statistically significant. azeliragon was generally well-tolerated with a 25% withdrawal rate over 18 months that was similar in both the placebo and treatment arms.
Consequently, vTv Therapeutics discontinued ongoing studies involving azeliragon, including the open-label extension study and part B of the STEADFAST study.
Nevertheless, a substantial portion of patients in part B of STEADFAST will have completed 12 months of treatment under the study protocol.
The failure of the late-stage study is disappointing for investors as the successful development and subsequent commercialization of the candidate would have significantly boosted growth prospects given the complexity of the drugs.
Of late, there has been many failures of drugs being developed for Alzheimer's. In February 2018, Merck MRK announced that it will stop the phase III study, APECS, which was evaluating verubecestat (MK-8931), an investigational small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in patients with prodromal Alzheimer's disease. The decision was taken after an external Data Monitoring Committee, which assessed overall benefit/risk during a recent interim safety analysis, concluded that it was unlikely that positive benefit/risk was possible. In January 2018, Pfizer PFE announced plans to end its research efforts to discover new drugs for Alzheimer's and Parkinson's diseases. Eli Lilly LLY is another major company which has suffered many failures in its attempt to develop drugs for Alzheimer's.
vTv Therapeutics currently carries a Zacks Rank #4 (Sell).
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