Seltorexant and the Major Depressive Disorder (MDD) landscape
Major Depressive Disorder (MDD) is one of the most commonly encountered mental disorders, with a prevalence rate in the United States of 4.7%. Globally, more than 300 million people of all ages suffer from depression. Depression is the leading cause of disability worldwide and is a major contributor to the overall global burden of disease. It is associated with significant comorbid medical conditions that include diabetes, hypertension and cardiovascular disease, and there is an increased risk of early mortality in patients with MDD.
Among those patients suffering from MDD disorders, some do not respond adequately to either SSRIs or SNRIs. Inadequate response to these pharmacological treatments is a major challenge to worldwide public health. Although it is widely considered that current intervention benefits approximately 60% of MDD patients, only about 30% to 40% of patients show full remission of their symptoms as defined by the MacArthur criteria (for example, a17-item Hamilton Depression Rating Scale (HDRS) score < 8).
To overcome the lack of adequate response, the use of atypical antipsychotics as adjunctive therapy for the management of patients with an inadequate response to standard of care has become one of the most widely used therapeutic strategies. Use of adjunctive atypical antipsychotics for MDD is associated with significant side effects such as weight gain, akathisia, and sedation. Several other approaches have been evaluated but, in most cases, withnon-conclusive results.
Innovative approaches are needed to improve current response rates to existing treatments. The orexin system is viewed as a pivotal system in the brain and its effects classically include promotion of feeding, maintaining homeostasis, arousal, modulation of sleep-wake circadian cycles and motivation. These functions are mediated via two orexin receptors, ORX1 and ORX2.
Seltorexant is the most advanced specific ORX2 molecule in clinical development with antagonistic activity when binding to its receptor. Seltorexant is currently being developed in two indications, specifically insomnia without associated psychiatric disorders and MDD in patients who have an inadequate response to SSRIs and SNRIs. Previous clinical trials have indicated that seltorexant might be useful in both indications.
About Seltorexant(MIN-202)
Seltorexant is a selective orexin-2 receptor antagonist underco-development by Janssen Pharmaceutica NV and Minerva as adjunctive therapy for MDD and for the treatment of insomnia disorder. The orexin system in the brain is involved in the control of several key functions, including metabolism, stress response and wakefulness. This system promotes arousal (wakefulness) and is hypothesized to play a role in excessive arousal, which occurs in subsets of patients with mood disorders, and to have clinical utility in the treatment of such patients.
About Minerva Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva’s proprietary compounds include: roluperidone(MIN-101), in clinical development for schizophrenia; seltorexant(MIN-202 orJNJ-42847922), in clinical development for insomnia and MDD;MIN-117, in clinical development for major depressive disorder (MDD); andMIN-301, inpre-clinical development for Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market under the symbol “NERV.” For more information, please visitwww.minervaneurosciences.com.
About the Minerva & Janssen collaboration
Minerva is developing seltorexant with Janssen Pharmaceutica, a Johnson & Johnson company. Under the terms of the collaboration, Minerva has exclusive commercialization rights to seltorexant and other orexin molecules for the treatment of insomnia and all other indications including MDD in the Minerva Territory (EU, Iceland, Lichtenstein, Switzerland & Norway). Royalties on sales outside of the Minerva Territory are payable by Janssen. Minerva pays royalties on sales (excluding sales of products for the treatment of insomnia) within the Minerva Territory.
Minerva has no financial obligations for development costs until completion of the Phase 2b development milestone. Minerva has strategic control of matters relating to the clinical development of seltorexant for insomnia.
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 statements herein with respect to the timing and scope of current clinical trials and results of clinical trials with roluperidone, seltorexant,MIN-117 andMIN-301; the timing and scope of future clinical trials and results of clinical trials with these compounds; the clinical and therapeutic potential of these compounds; our ability to successfully develop and commercialize our therapeutic products; the sufficiency of our current cash position to fund our operations; and management’s ability to successfully achieve its goals. 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, whether roluperidone, seltorexant,MIN-117 andMIN-301 will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 6, 2019. Copies of reports filed with the SEC are posted on our website atwww.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.
