Minerva suffers another CNS defeat; Eli Lilly wins OK for tau-based Alzheimer's diagnostic
→ Months after a depressing end to Minerva Neurosciences‘ quest to develop a depression drug, the Waltham, Massachusetts-based drug developer unveiled more bad news as its lead experimental compound — roluperidone — failed to succeed in a late-stage schizophrenia study. The Achilles heel of many a CNS failure reared its ugly head again: the dreaded larger-than-life placebo effect. But company chief Rémy Luthringer isn’t throwing in the towel just yet.
“Even though this study didn’t achieve its primary and key secondary endpoints, primarily due to a larger than expected placebo effect at Week 12, results obtained with the 64 mg dose including the early onset of effect and functional improvement … suggest roluperidone merits continued investigation for the treatment of primary negative symptoms,” he said in a statement.
→ There may be little success in advancing therapeutics to fight Alzheimer’s disease, but there is some encouraging news on the diagnostics front. On Friday, Eli Lilly said it had secured FDA approval for the first radioactive diagnostic agent designed to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease. Until now, this information was could only be gauged at autopsy.
→ In response to Melinta’s superior offer to acquire Tetraphase and its marketed antibiotic Xerava, AcelRx has sweetened up its proposal. The new deal would consist of both AcelRx stock and a contingent value right (CVR), with the total upfront valued at around $37 million. It marks a big jump from the original offer of around $14.5 million — if still lower than Melinta’s proposal to pay $34 million in cash plus $16 million worth of CVRs.
→ Last year, Zafgen put themselves up for sale. The FDA placed the company under a clinical hold after determining their drug was likely to cause cardiovascular problems, and when Zafgen’s own animal data told them that fear wasn’t going away, they determined it was time to move on. Today that sale is complete. The company opted to reverse merge with Chondrial Therapeutics – a biotech developing a drug for the rare, progressive disorder Friedreich’s ataxia — and form Larimar Therapeutics. The new company has access to the $40 million Zafgen had left on its balance sheet, plus an injection of $80 million in a round led by Cowen. Their lead candidate is now in Phase I.