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Minerva Neurosciences Receives Complete Response Letter from FDA for New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

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Minerva Neurosciences, Inc. receives a Complete Response Letter from the FDA for roluperidone, citing clinical deficiencies in the NDA submission for treating negative symptoms in schizophrenia patients.
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  • The FDA issued a Complete Response Letter to Minerva Neurosciences, Inc. for their NDA submission of roluperidone, highlighting clinical deficiencies.
  • The NDA lacked data on concomitant antipsychotic administration and needed additional studies to support safety and effectiveness.
  • The safety database for roluperidone lacked sufficient subjects exposed to the proposed dose for at least 12 months.
  • The FDA also provided comments on clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues in addition to the clinical deficiencies.

The issuance of a Complete Response Letter (CRL) by the FDA is a significant regulatory event for Minerva Neurosciences, indicating that the agency requires additional evidence before it can approve roluperidone. The requirement for another positive study to establish the efficacy and safety of the drug for treating negative symptoms in schizophrenia patients suggests that the current evidence is not robust enough to meet FDA standards. This could imply a substantial delay in the drug's potential market entry, affecting projected revenues and the company's valuation.

Furthermore, the FDA's request for data on concomitant antipsychotic administration is crucial. In real-world settings, patients with schizophrenia often take multiple medications and understanding how roluperidone works in conjunction with other therapies is vital for its safe and effective use. The lack of long-term safety data also raises concerns about potential side effects that could emerge with extended use of the drug, which is a common scrutiny point for the FDA to ensure patient safety.

The CRL's impact on Minerva Neurosciences' stock performance can be multifaceted. Investors often view regulatory setbacks as negative indicators, potentially leading to a decline in stock price due to increased uncertainty and delayed revenue streams. The costs associated with conducting additional studies can be significant and the company will likely need to reassess its financial projections and funding requirements. This situation may also affect investor confidence, especially if there are concerns about the company's ability to raise additional capital or manage its burn rate effectively.

On the other hand, the company's commitment to continue working closely with the FDA and address the feedback could help mitigate some of the negative sentiment. If Minerva can successfully navigate the regulatory hurdles and eventually secure approval for roluperidone, it could capture a share of the market for schizophrenia treatments, which remains a significant unmet medical need.

The schizophrenia treatment market is characterized by a need for drugs that can effectively manage negative symptoms, which include social withdrawal, apathy and anhedonia, among others. Current treatments primarily address the positive symptoms such as hallucinations and delusions. If Minerva can eventually demonstrate that roluperidone has a clinically meaningful impact on negative symptoms, the drug could fulfill an underserved niche in the market.

However, the delay in approval may allow competitors to strengthen their positions or develop alternative therapies. It is important to monitor developments in this space, as any new entrants or advancements in treatment could alter the competitive landscape by the time roluperidone is potentially approved. Stakeholders should also consider the broader implications of the FDA's feedback on industry standards for clinical evidence, as this could influence the development strategies of other CNS-focused therapies.

BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia.

In the CRL, the FDA cited the following clinical deficiencies:

  1. Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness.

  2. The NDA submission lacks data on concomitant antipsychotic administration.

  3. The NDA submission lacks data needed to establish that the change in negative symptoms of schizophrenia with roluperidone treatment was clinically meaningful.

  4. The submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months.

To address these deficiencies, the FDA stated that Minerva must submit at least one additional positive, adequate, and well-controlled study to support the safety and effectiveness of roluperidone for the treatment of negative symptoms. Minerva must also provide additional data to demonstrate the safety and efficacy of roluperidone co-administered with antipsychotic medications, to support that observed effect on negative symptoms with roluperidone treatment corresponds to a clinically meaningful change, and to demonstrate the long-term safety of the proposed dose.

In addition to the clinical deficiencies described above, the FDA also provided comments on, among other items, clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues.

“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” said Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. “There is a critical need for a treatment for the negative symptoms of schizophrenia. We believe that roluperidone is a safe and effective therapy for negative symptoms of schizophrenia and we will review FDA’s feedback and consider our potential paths forward, including continuing to work closely with the FDA and providing any additional information as needed, with the goal of bringing this much needed therapy to patients and physicians.”

About roluperidone

Roluperidone has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in the regulation of important brain functions, including mood, cognition, sleep, and anxiety.

Roluperidone was designed to avoid a direct blockade of dopaminergic receptors (the key pharmacological target for first- and second-generation antipsychotics), while maintaining blockade of a specific subtype of serotonin receptor called 5-HT2A (an additional key target of second-generation antipsychotics) as well as additional pharmacological targets (sigma2 and adrenergic-α1A).

About Schizophrenia and Negative Symptoms
Schizophrenia is a chronic, severe, and debilitating type of mental illness characterized by distortions in thinking, perception, emotions, language, sense of self and behavior. Schizophrenia affects 20 million people worldwide. (World Health Organization).

Negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure. Negative symptoms are characterized by five constructs: blunted affect, alogia, avolition, anhedonia, and asociality (Marder and Galderisi, 2017).

Negative symptoms are the main cause of the poor functional outcome of patients suffering from schizophrenia (Harvey et al., 2020) and may also be one of the main reasons ultra-high risk adolescents may develop full blown schizophrenia (Gomes and Grace, 2017). There are currently no treatments approved for negative symptoms of schizophrenia in the US.

Minerva believes that research continues to emerge indicating that there is a large subgroup of patients with schizophrenia who have moderate to severe primary negative symptoms and minimal positive symptoms (Galderisi 2021) and have a low risk of worsening of positive symptoms even in the absence of antipsychotic treatments (Harrow 2013; Moilanen 2016Murray 2016;  Wils 2017; Wunderink 2013; Landolt 2016).

About Minerva Neurosciences

Minerva Neurosciences, Inc. (Nasdaq: NERV) is a clinical-stage biopharmaceutical company focused on developing product candidates to treat central nervous system (CNS) diseases. Our goal is to transform the lives of patients with improved therapeutic options. Minerva’s portfolio of compounds includes roluperidone, for negative symptoms of schizophrenia, and MIN-301, for Parkinson’s disease. For more information, please visit our website.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include, but are not limited to, statements herein with respect to roluperidone’s potential as a safe and effective therapy for the treatment of negative symptoms of schizophrenia and critical need for such treatment; expectations concerning Minerva’s ability to remediate or otherwise resolve deficiencies identified in the CRL; expectations concerning meeting request with the FDA and the outcome thereof; Minerva’s plans to discuss next steps and timing for resolution of deficiencies identified in the CRL; and general expectations concerning decisions of regulatory bodies, including the FDA, and the timing thereof. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors including, without limitation, risks associated with developing biopharmaceutical product candidates; uncertainties associated with regulatory processes, including the content and timing of decisions by the FDA; Minerva’s ability to address FDA’s feedback and timing thereof; management’s ability to successfully execute on its plans; Minerva’s ability to raise additional capital to fund its operations and corporate objectives on terms acceptable to Minerva; general economic conditions; and other factors that are described under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 22, 2024. Copies of reports filed with the SEC are posted on our website at http://ir.minervaneurosciences.com/. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

Contact:
Investor inquiries:
Frederick Ahlholm
Chief Financial Officer
Minerva Neurosciences, Inc.
Info@minervaneurosciences.com

Media inquiries:
Helen Shik
Principal
Shik Communications LLC
Helen@ShikCommunications.com


The FDA issued a Complete Response Letter citing clinical deficiencies in the NDA submission for treating negative symptoms in schizophrenia patients.

The NDA lacked data on concomitant antipsychotic administration and needed additional studies to support safety and effectiveness.

The safety database lacked sufficient subjects exposed to the proposed dose for at least 12 months.

The FDA also provided comments on clinical pharmacology, product quality, biopharmaceutics, and nonclinical issues in addition to the clinical deficiencies.
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About NERV

minerva neurosciences, inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of a portfolio of product candidates for the treatment of central nervous system diseases. its lead product candidate is roluperidone, which is in phase iii clinical trial, a compound for the treatment of schizophrenia. the company is also developing seltorexant that has completed phase iib clinical trial for treating insomnia and major depressive disorders; and min-301, which is in pre-clinical trial, a soluble recombinant form of the neuregulin-1b1 protein for the treatment of parkinson's disease. minerva neurosciences, inc. has a license agreement with mitsubishi tanabe pharma corporation for the development and commercialization of the roluperidone worldwide, excluding asia; and co-development and license agreement with janssen pharmaceutica, n.v. for the development of seltorexant. the company was formerly known as cyrenaic pharmaceuticals, inc. and changed its