Lundbeck reported Thursday that idalopirdine, also known as Lu AE58054, failed to meet the primary and secondary endpoints in the first of three late-stage studies testing the experimental 5-HT6 receptor antagonist in patients with mild-to-moderate Alzheimer's disease. "We are disappointed about the outcome" of the STARSHINE trial, said chief scientific officer Anders Gersel Pedersen, adding "the Phase II data were very encouraging, but unfortunately, these data failed to replicate those findings."
The primary endpoint was a reduction in the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score for idalopirdine in combination with donepezil, which Pfizer and Eisai co-market as Aricept. Lundbeck said the drug showed a "weak efficacy profile" at both doses tested, but was safe and well tolerated, adding that further analysis of the trial is ongoing.
In 2013, Lundbeck and partner Otsuka Pharmaceuticals presented Phase II results showing that treatment with idalopirdine as an add-on to donepezil for six months significantly improved cognitive performance in patients with moderate Alzheimer's disease, compared with donepezil alone.
The Danish drugmaker said the two remaining studies in the Phase III idalopirdine programme, STARBEAM and STARBRIGHT, will continue as planned, with data anticipated in the first quarter of next year. The therapy was awarded a fast-track designation by the FDA in July.
Meanwhile, Axovant Sciences, whose investigational 5-HT6 receptor antagonist intepirdine, also known as RVT-101, is currently being tested in patients with mild-to-moderate Alzheimer's disease in the Phase III MINDSET study, saw its shares fall as much as 23 percent on news of the STARSHINE results. However, Baird analyst Brian Skorney remarked "we think the reaction was unwarranted, as there are some key differences on study powering and dosing that differentiate inteperdine and idalopirdine." He suggested "a potential trend on the primary endpoint is consistent with our view that idalopirdine is underdosed and underpowered and inteperdine will succeed where this competitor failed."
For related analysis, see ViewPoints: Rainclouds darkening on the horizon for Axovant's intepirdine, and ViewPoints: Axovant adds more eggs to its basket of symptomatic Alzheimer’s disease candidates.
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