Palm Beach, FL – November 14, 2022 – FinancialNewsMedia.com News Commentary – Anti-anxiety drugs are medications that are used to treat anxiety disorders that are mainly used to relieve anxiety and tension, work by reducing the symptoms of anxiety, such as fear, stress, and panic attacks. A report from PS Market Research projected that the global market for anxiety and depression treatment products is projected to progress at a CAGR of 3.3% through 2030. It said the major factors responsible for the growth of the market include growing geriatric population, rising awareness about mental diseases and their treatment, and increasing number of product approvals.  The report said: “With the growing age, individuals go through a number of stress conditions. Some of which are common to all age groups, while some are old-age specific such as loss in capabilities to function properly. In addition, the elder people experience reduced socioeconomic status with retirement, which worsen the situation as it leads to isolation and loneliness. Thus, the older people are more vulnerable toward mental disorders, such as anxiety and depression. Thus, the rising cases of anxiety and depression in elderly population, across the world, would help the anxiety and depression treatment market growth.  The awareness about mental diseases has increased across the world, owing to the increased initiatives taken by private and public healthcare institutions… In recent years, the players in the anxiety and depression treatment industry have indulged themselves in more product launches to offer a better product portfolio than other competitors.”  Active biotech and pharma companies in the markets this week include Marvel Biosciences Corp. (TSX-V: MRVL), Sage Therapeutics, Inc. (NASDAQ: SAGE), Minerva Neurosciences, Inc. (NASDAQ: NERV), atai Life Sciences N.V. (NASDAQ: ATAI), Cybin Inc. (NYSE: CYBN) (NEO: CYBN).

The article added: “Mergers and acquisitions allow pharmaceutical companies to increase their portfolios, expand their reach, and enhance their workflow, in the anxiety and depression treatment market. Also, several key players are involved in mergers and acquisitions to accelerate the pace of drug discovery and development, in order to gain a competitive edge… Thus, these development strategies will create a diverse portfolio of depression and anxiety drugs in the market, leading to more demand for such drugs. Geographically, North America generated the largest share in the anxiety and depression treatment market… and is expected to maintain its position in coming years. This is majorly ascribed to the rise in number of cases of pain, coupled with the greater prevalence of anxiety and major depressive disorders, growth in awareness regarding mental health, high-disposable income, and increase in number of prescriptions for antidepressants, in the region.”

Marvel Biosciences Corp. (TSXV: MRVL) BREAKING NEWS:  Marvel Biosciences Lead Drug Candidate MB-204 Demonstrated Superior Anti-Anxiety Activity Over FDA-Approved Istradefylline in Head-to-Head Pre-clinical Studies – Marvel Biosciences Corp. and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company“ or “Marvel“), is pleased to announce that in a pre-clinical test for anxiety, its lead drug candidate MB-204, a fluorinated derivative of Istradefylline, out-performed Istradefylline in a head-to-head pre-clinical and in depressive and anti-anxiety studies. Istradefylline is the only US FDA approved A2a receptor antagonist currently approved to treat Parkinson’s disease.

“This head-to-head study suggests MB-204 has a superior anti-anxiety activity compared to its parental molecule Istradefylline,” said Dr Mark Williams, Chief Science Officer of Marvel Biosciences. “What was particularly interesting is that the mice treated with MB-204 had more social interactions than mice treated with Istradefylline. Social isolation can compound depression and anxiety, so this is an intriguing finding for MB-204.”

“Depression and anxiety can be debilitating and it continues to be a growing problem among many age groups,” said Rod Matheson CEO of Marvel Biosciences. ”With rates of up to one in eight adults taking an anti-depressive, and the recent revisiting of the serotonin hypothesis of depression, the need for novel anti-depressants and anti-anxiety medications is greater than ever. We are on track to enter Phase I FDA human trials as early as the first quarter of next year and hope to advance our unique lead candidate MB-204 through the FDA approval process as quickly as possible to help alleviate patients’ suffering from these conditions with a new mechanism of action.”

Using the well-established elevated plus maze pre-clinical model for anxiety, and the same doses of MB-204 as compared to Istradefylline (7.5 mg/kg) resulted in:

• Longer times spent in the open arms, especially in the first minute, which indicates a larger anti-anxiety effect
• Engaged in more risky behaviour than Istradefylline, as measured by head dipping behaviours again suggesting less anxiety
• Did not trigger excessive locomotive activity whereas Istradefylline did promote excessive locomotive activity
• Promoted ultrasonic vocalizations (USVs), whereas Istradefylline did not evoke any USVs which is indicative of social communication

CONTINUED… Read this full press release and more news for Marvel Biosciences at:  https://www.financialnewsmedia.com/news-mrvl/    

Other recent developments in the biotech industry of note include:

Sage Therapeutics, Inc. (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, recently reported business highlights and financial results for the third quarter ended September 30, 2022.

“This has been an important year for Sage, marked by the execution of significant milestones across our franchises. Looking ahead, we remain focused on the completion of the NDA submission for zuranolone in MDD and PPD, and are well into commercialization preparations to support a potential launch.

Patients with depression are desperate to find new medicines that are safe, rapid-acting, short course, and have a sustained effect. We believe zuranolone, if approved, has the potential to deliver a new treatment option for patients,” said Barry Greene, Chief Executive Officer at Sage Therapeutics. “In parallel, our team is advancing multiple clinical studies across our pipeline that span our neuropsychiatry and neurology franchises. I am proud of the tremendous progress our team has made on behalf of patients this year and am energized by the momentum we have going into 2023 and beyond.”

Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, recently reported key business updates and financial results for the quarter ended September 30, 2022.

Roluperidone Update 
As announced on August 17, 2022, the company submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for roluperidone to treat negative symptoms in schizophrenia. The submission included data from two clinical trials, the company’s phase 2b and phase 3 studies, in patients diagnosed with schizophrenia with negative symptoms.

atai Life Sciences N.V. (NASDAQ: ATAI), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, recently reported financial results for the quarter ended September 30, 2022 and provided a business update.

“In addition to multiple study initiations this quarter, we have announced two positive clinical trial results, with more on the way,” said Florian Brand, Co-Founder and Chief Executive Officer of atai. “We’re excited about the upcoming Phase 2a topline results of PCN-101 that could represent a meaningful shift in the current treatment paradigm for patients.”

“The third quarter of 2022 demonstrated our strong capability to execute. Not only did we have first patient dosed of a Phase 1 trial of VLS-01 and initiation of a Phase 1 trial of EMP-01, we also began collecting data on our digital therapeutic app supporting ‘(mind)set-and-setting’ prior to dosing,” said Srinivas Rao, Co-Founder and Chief Scientific Officer. “Moreover, positive safety, tolerability, and pharmacodynamic results from both KUR-101 and GRX-917 Phase 1 trials reinforce our belief in our unique approach to drug selection, which emphasizes prior evidence in humans. Finally, we continue to strengthen our enabling technology capabilities through initiation of a proof-of-concept Phase 1 clinical trial of a sol-gel based technology which could enable direct-to-brain delivery of various compounds in development across atai’s pipeline.”

Cybin Inc. (NYSE AMERICAN: CYBN) (NEO: CYBN) recently announced that its CYB004-E Phase 1 trial evaluating N,N-dimethyltryptamine (“DMT“) has completed dosing for four out of five participant cohorts and The Safety Review Committee has confirmed no clinically significant safety or tolerability issues. The CYB004-E Phase 1 trial was acquired from Entheon Biomedical Corp. (“Entheon“) in July 2022.

The CYB004-E trial marks one of a number of strategic transactions that Cybin has completed in recent months to support its research and development pipeline of active psychedelic-based programs and potential future novel drug candidates. The acquisition of the CYB004-E Phase 1 trial replaced Cybin’s planned pilot study that was expected to commence in the third quarter of 2022, and as such, has served to potentially accelerate the clinical development path of CYB004, the Company’s proprietary deuterated DMT molecule for the potential treatment of anxiety disorders.

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