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.
|Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter.||Subscribe|
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None.here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with: None. Please click here for more information.Click
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
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.
Company–Specific Regulatory Disclosures: BTIG LLC expects to receive or intends to seek compensation for investment banking services in the next 3 months from: Minerva Neurosciences, Inc. (NERV)
General Disclosures: Research reports produced by BTIG LLC (“BTIG”) are published for and intended to be distributed solely to BTIG institutional and corporate clients. Recipients of BTIG reports will not be considered clients of BTIG solely because they may have received such BTIG report.
To the extent recipient accesses BTIG research, whether on a BTIG research website or through a third-party platform, BTIG is able to search, filter, download and review information on the readership of BTIG’s research, including the specific research consumed and the name, company name, email address and, in certain circumstances, the location of the individual who accessed the research (the “Readership Information”). Recipient consents to BTIG’s receipt of the Readership Information, including receipt of that information from a third party.
The research analyst(s) responsible for the preparation of this report receives compensation based upon a variety of factors, including the quality and accuracy of research, internal/client feedback, and overall Firm revenues. BTIG reports are based on public information and BTIG considers the same to be reliable, comprehensive information, but makes no representation or warranty that the reports are accurate or complete. BTIG opinions and information provided in this report are as of the date of the report and may change without notice. An issuer may be classified as “Under Review” or “Research Restricted”. In these cases, investors should consider any previous investment recommendation and/or rating to a subject company/issuer to no longer be current and should not be relied upon nor considered a solicitation.
This research report is not an offer to buy or sell or solicitation of an offer to buy or sell any security in any jurisdiction where such an offer or solicitation would be illegal. This research report was not drafted specifically for any particular individual or entity and is not a personal recommendation to participate in any particular trading strategy or transaction. Any recipient of this research report should obtain independent advice specific to their personal circumstances before undertaking any investment activity and must make their own independent evaluation of any securities or financial instruments.
Facts, views or opinions presented in this report have not been reviewed by, and may not reflect information known to, employees or other professionals in the “BTIG Group” (BTIG Group includes, but is not limited to, BTIG and its parents, subsidiaries and/ or affiliates). BTIG Group employees, including Sales Representatives and Traders, may provide oral or written commentary or advice that may be inconsistent with the opinions and/or views expressed in this research report. BTIG Group employees and/or its affiliates not involved in the preparation of this research report may have investments in securities or derivatives of securities of companies mentioned in this report that are inconsistent with the views discussed in this report. Investors in securities products bear certain risks in conjunction with those investments. The value of, and income from, any investments may vary because of changes in interest rates or foreign exchange rates, securities prices or market indexes, operational or financial conditions of companies or other factors within or beyond the companies’ control.
Recipient of the research reports should be aware that investments in securities may pose significant risks due to the inherent uncertainty associated with relying on forecasts of various factors that can affect the earnings, cash flow and overall valuation of a company.
Any investment in securities should be undertaken only upon consideration of issues relating to the recipient’s overall investment portfolio and objectives (such as diversification by asset class, industry or company) as well as time horizon and liquidity needs.
Further, past performance should not be taken as an indication or guarantee of future performance, and no representation or warranty, express or implied, is made regarding future performance. There may be time limitations on the exercise of options or other rights in any securities transactions. Investing in foreign markets and securities, including ADRs, is subject to additional risks such as currency fluctuation, limited information, political instability, economic risk, and the potential for illiquid markets. Investing in emerging markets may accentuate these risks. Non-U.S. reporting issuers of foreign securities, however, may not make regular or complete public disclosure relating to their financial condition or the securities that they issue.
The trademarks and service marks contained herein are the property of their respective owners. Third-party data providers make no warranties or representations of any kind relating to the accuracy, completeness, or timeliness of the data they provide and shall not have liability of any damages of any kind relating to such data. The report or any portion hereof may not be reprinted, sold or redistributed without the written consent of BTIG. This report is intended only for use by the recipient. The recipient acknowledges that all research and analysis in this report are the property of BTIG and agrees to limit the use of all publications received from BTIG within his, or her or its, own company or organization. No rights are given for passing on, transmitting, re transmitting or reselling the information provided.