FDA turns down Minerva's schizophrenia drug over insufficient data
27 Feb 2024
Clinical ResultPhase 2Phase 3Drug ApprovalAcquisition
The FDA has declined to approve Minerva Neurosciences' roluperidone (MIN-101) to treat negative symptoms in patients with schizophrenia. In its complete response letter (CRL), the agency cited a number of clinical deficiencies and called for Minerva to conduct at least one more study before it would reconsider the drug for approval.
"We are disappointed… and will request a meeting to discuss the issues raised and attempt to address FDA's feedback," said CEO Remy Luthringer in a statement Tuesday. Company shares toppled 59% on the news.
Back-to-back RTF letters
This marks the latest roadblock in Minerva's quest to get the US regulator to sign off on the 5-HT2A and σ₂ receptor antagonist. It had previously run into challenges getting the FDA to even agree to review the application, receiving a refusal-to-file letter in October 2022 that was upheld that December. The biotech succeeded in appealing early last year, allowing the application to move forward with an FDA review.
While positive symptoms of schizophrenia are generally well managed with antipsychotics, Minerva says negative symptoms – characterised by blunted affect, alogia, avolition, anhedonia and asociality – are often the main burden of illness, and can impact a patient's quality-of-life.
The company's original filing contained results from two studies in patients with moderate-to-severe negative symptoms and stable positive symptoms of schizophrenia. Roluperidone significantly reduced negative symptoms in the Phase IIb MIN-101C03 trial, but "marginally" missed the bar in the primary analysis for the Phase III MIN-101C07 study.
However, Minerva did highlight a "nominal statistically significant improvement" with roluperidone in a modified patient population of the Phase III study once "implausible results" from one of the clinical trial sites had been excluded.
Combo route
Still, the FDA said that having only one study demonstrating statistical significance on the primary efficacy endpoint "is insufficient on its own to establish substantial evidence of effectiveness." The FDA submission also lacked data on concurrent use of antipsychotics and on the clinical significance of negative symptom improvement. Moreover, the safety data submitted didn't have enough people who took the recommended 64mg dose of roluperidone for at least a year.
While the CRL was not unexpected, H.C. Wainwright analysts noted that Minerva might now be considering going the combination route. It recently started evaluating the potential of roluperidone with olanzapine for adults with moderate-to-severe negative symptoms of schizophrenia. The company is expected to report results in the first quarter.
"Recall, privately-held Boehringer Ingelheim, which owns ~18% of Minerva, invested in Minerva through a $20-million PIPE in 2Q23, indicating Boehringer recognised roluperidone's commercial potential and was well aware of the FDA's concerns about the existing data package," the analysts said. "We think Boehringer's investment in Minerva reflects interest in acquiring the company outright and is a potential outcome, perhaps likely outcome, if FDA issues a CRL as we expect."
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