Given mixed efficacy results for Minerva Neurosciences Inc. (NERV:NASDAQ) roluperidone as a schizophrenia treatment, approval "still seems relatively unlikely," but U.S. Food and Drug Administration (FDA) feedback hints at a chance of approval because such a drug is greatly needed, BTIG analyst Dr. Thomas Shrader purported in an August 22, 2022 research note.
Massachusetts-based Minerva expects to hear back from the FDA in Q4/22, having answered the questions the agency raised in March at a Type C meeting regarding the biopharma's new drug application for roluperidone 64 milligrams (64 mg) for negative symptoms in schizophrenia, based on Phase 2 and Phase 3 data.
The questions "seem consistent with an agency weighing risk-reward in an area of high unmet need," Shrader noted. The FDA wanted to know:
1) If roluperidone interferes with the safety and efficacy of antipsychotic drugs
The median times to symptom resolution with 32 mg and 64 mg of Minerva's drug in Phase 2b and Phase 3 suggests no interference: 16 days and 18 days, respectively, versus 23 days with placebo. Further data showed roluperidone efficacy does not come at the cost of increased relapse. The relapse rate shown in the Phase 3 trial, 11.7% over one year, was less than the 25% rate expected over the same period with antipsychotics.
2) How Minerva can identify ideal patients for roluperidone
Of the estimated 2.2 million patients with schizophrenia in the U.S., about 1.3 million are receiving treatment. About 900,000 patients suffer from negative symptoms, and these people are ideal for roluperidone treatment, Shrader relayed. Having represented this population in its Phase 2b and Phase 3 studies, Minerva showed it can reliably identify them moving forward.
3) How schizophrenia patients in the U.S. compare to those outside the States
4) What statistical efficacy evidence exists for roluperidone on negative schizophrenia symptoms
Shrader pointed out that the development of drugs like roluperidone often is not straightforward and typically requires additional trials until a clear understanding is gotten of "where" the drug works, in which patients, at what stage of disease, and the like. This seems to be the case with Minerva's schizophrenia drug.
"As a result, we consider this drug package quite high risk for approval now but much more supportive of partnering with a larger company that could bankroll additional trials," Shrader added.
The analyst explained the problems surrounding roluperidone's efficacy results.
Roluperidone was shown to be effective in Phase 2 and Phase 3 trials. However, the placebo also showed a treatment effect to the same statistically significant degree as Minerva's drug. Also, between the two studies, the treatment effect with roluperidone remained consistent, but with placebo, it increased. Further, the large placebo effect occurred to a greater degree at one of the trial sites.
"The general idea is that there is always a placebo effect, but that this effect should wane with time, a trend not observed in the data," Shrader explained.
An open-label extension of Phase 3 was done, but only the roluperidone arm was continued. Positively, it showed the treatment effect "continued to increase," Shrader relayed. Thus, "the argument that the open-label extension treatment effect is 'real' is only a logical one."
BTIG remains bullish on Minerva's drug.
"Overall, we see MIN-101 (roluperidone) as having a unique place in the schizophrenia treatment landscape less prone to generics that overwhelmingly treat positive symptoms of the disease (things like hallucinations)," Shrader wrote.
BTIG had a Buy rating and a $6 per share price target on Minerva, which is currently trading at around $6.09 per share.
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Disclosures For BTIG LLC., Minerva Neurosciences Inc., August 22, 2022
Analyst Certification: I, Thomas Shrader, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report. I, Sung Jun Hong, hereby certify that the views about the companies and securities discussed in this report are accurately expressed and that I have not received and will not receive direct or indirect compensation in exchange for expressing specific recommendations or views in this report.
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