On the Trail of Better Therapeutics for Depression

 NetworkNewsWire Editorial Coverage: Big pharma and life science companies are making big news these days. The drug-development space is seeing strong investor interest as these companies make breakthrough advancements that address vast unmet medical needs. Strategic M&A moves are adding spice to the gumbo for investors as pioneering research remains focused on providing life-changing treatments for those suffering from a myriad of disorders. One of the largest and trickiest medical disorders of mankind may be on the cusp of more effective treatment. Depression is often kept in the dark and not talked about, but it is estimated that more than 17 million adults in the United States experienced at least one major depressive episode in 2019 alone, while one out of every four people in the world struggle with a diagnosable mental disorder. Life sciences company Cybin Inc. (Cybin Profile) is at the vanguard of new therapeutic protocols that target these disorders. Cybin is intent on developing psychedelic therapeutics along with unique delivery mechanisms that target depression as well as other psychiatric and neurological conditions. The company could benefit from two game-changing announcements made in the past few days: the company just completed its previously announced reverse takeover and a groundbreaking study published in JAMA Psychiatry reports that in a recent study a treatment featuring psilocybin actually worked better than typical antidepressant medications. Other drug-development companies are experiencing similar milestone moments. Last month Praxis Precision Medicines Inc. (NASDAQ: PRAX) closed on its upsized initial public offering of 11,500,000 shares of common stock, resulting in aggregate gross proceeds to Praxis of $218.5 million. Earlier this year, AbbVie Inc. (NYSE: ABBV) completed a transformative acquisition of Allergan. Less than a year ago, Axsome Therapeutics (NASDAQ: AXSM) realized more than $200 million when it closed on its public offering. And this summer Relmada Therapeutics Inc. (NASDAQ: RLMD) uplisted to trade on the Nasdaq Global Select Market.

• Cybin’s reverse takeover creates new publicly traded company focused on development of psychedelic therapeutics targeting neurological, psychiatric conditions.
• Recent research observed that psilocybin treatment had “more than four times greater effect” than usual antidepressant medications.
• Cybin R&D pipeline includes multiple studies and trials.

Focused on Breakthrough Psilocybin Therapeutics

Staggering amounts of big money are moving into the drug-development sector, and Cybin Inc. is seeing its share. The leading life sciences company recently announced that it completed a reverse takeover transaction announced last month; the company also expects to start trading common shares on the NEO exchange as soon as week under the symbol CYBN.

According to Cybin, the reverse takeover of Clarmin Explorations Inc. will result in a unique public company. The new company will focus on psychedelic drug development, unique delivery mechanisms, and improved novel compounds and protocols that may finally offer relief to the millions that suffer from depression and other psychiatric or neurological conditions.

“We are very pleased to have completed the Reverse Takeover and to have received conditional approval to list CYBIN’s shares on the NEO Exchange,” said Cybin CEO Doug Drysdale. “We anticipate it will help us to enhance our visibility within the investment community and broaden our investor base, with the goal of building long-term shareholder value. It also represents an important step forward in advancing our development plans. We believe in the application of psychedelic therapies and look forward to advancing them and our other product candidates.”

In addition, Cybin Inc. previously announced the closing of a private placement offering resulting in aggregate gross proceeds of CDN$45 million. Cybin plans to use the net proceeds from this offering to further develop the company’s psychedelic therapies and nutraceutical products, as well as for working capital and general corporate purposes. The offering included participation from several new investors including RA Capital Management, Janus Henderson Investors, Kearny Venture Partners, LifeSci Venture Partners and Bail Capital.

Effect ‘More than Four Times Greater’

In a world where one out of every four people struggle with a diagnosable mental disorder, people are desperately searching for answers. Cybin is working to identify answers and address an enormous unmet medical need. The company is intent on becoming the first life sciences company to bring an effective psilocybin therapeutic drug to market targeting major depressive disorder (MDD), and a recent study may indicate that Cybin’s focus is spot on.

Earlier this month, an article in the journal JAMA Psychiatry reported the remarkable findings of a study featuring the hallucinogen psilocybin. During the study, 27 patients received two doses of psilocybin on different days and also received about 11 hours of psychotherapy; half the participants began treatment immediately while the other half began treatment eight weeks later. The research team observed that the treatment had an effect “more than four times greater” than the typical antidepressant medications.

“There was a significant reduction in depression in the immediate-treatment group compared to those in the waitlist,” reported Alan Davis, an author of the study and a faculty member at both Johns Hopkins University and Ohio State University in an NPR article titled “Rigorous Study Backs a Psychedelic Treatment for Major Depression.”

“The effect happened within one day after the first session and sustained at that reduced level through the second psilocybin session all the way up to the one-month follow-up,” Davis continued.

“The study is notable for its scientific rigor,” said Charles F. Reynolds III, MD, distinguished professor emeritus of psychiatry at the University of Pittsburgh’s School of Medicine. “It offers, I think, a good deal of promise as a feasible approach to treating particularly chronic forms of depression.” Reynolds also observed that the emergence of treatments such as psilocybin may signal a new era in treatments.

At the Vanguard of Research

The JAMA report noted that additional research and study on all aspects psilocybin is warranted, and Cybin has already made significant strides. Earlier this year, Cybin entered into a feasibility agreement with IntelGenx Corp. for the development of an orally dissolving film for the delivery of pharmaceutical-grade psilocybin. This could become a groundbreaking advancement not just for the delivery psilocybin therapeutics but also for more effective treatments of mental disorders.

“Compared to oral psilocybin capsules, which are subject to variable intestinal absorption and high first-pass metabolism in the liver, the systemic bioavailability of orally dissolving psilocybin film is expected to be quite high,” said Cybin chief medical officer, Jukka Karjalainen MD. “Additionally, the dose of psilocybin administered by an orally dissolving film is expected to be a fraction of the requirement in oral capsules. These features have the potential to increase both the safety and efficacy of psilocybin when administered in this manner.”

As part of that agreement, Cybin is currently involved in an oral-film bioequivalence study designed to compare molecular delivery of psilocybin through its fast-acting oral films in contrast to capsules. This is just one of the several clinical trials and studies in the company’s rapidly growing pipeline.

The Cybin pipeline also includes:

• A phase 2a and phase 2b clinical trial to fast track drug approval targeting Major Depressive Disorder (MDD).
• A clinical safety and efficacy study targeting microdosing that may lead to a clinical trial for anxiety, ADHD and overall cognitive flexibility
• A phase 2 clinical trial targeting addition through the delivery of psilocybin through an oral film, with further studies leveraging a transdermal, “slow-dose” delivery mechanism.

Mental disorders have long been misunderstood, attributed to possession by evil or to personal shortcomings comings. Science has debunked the stigmas and revealed that typically a chemical imbalance occurs in the brain. The progress in therapeutics has come a long way from exorcisms and shamans yet millions still suffer. New therapeutics are coming that may well provide relief to the suffering and opportunity to the savvy.

Smart Players Attracting Attention

Cybin isn’t the only company making headway in this area. Other smart players are seizing opportunities to attract investors and strengthen their position in the space.

Praxis Precision Medicines Inc. (NASDAQ: PRAX) closed on its upsized initial public offering of 11,500,000 shares of common stock. The clinical-stage biopharmaceutical company translates genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal imbalance. The shares began trading on the Nasdaq Global Select Market on Oct. 16, 2020, under the ticker symbol PRAX. Praxis has established a broad portfolio, including five disclosed programs across multiple CNS disorders including depression, epilepsy, movement disorders and pain syndromes.

AbbVie Inc. (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that it has completed its acquisition of Allergan plc following receipt of regulatory approval from all required authorities. The acquisition creates biopharmaceutical company with leadership positions in five key therapeutic areas: immunology, hematologic oncology, neuroscience and Allergan aesthetics. The new company will have a robust portfolio of on-market and pipeline assets well-positioned for sustainable long-term growth,

Axsome Therapeutics (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of CNS disorders, closed its underwritten public offering of 2,300,000 shares of common stock for $87 per share. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, including one — AXS-05 — that is currently in a phase 3 trial and is being developed for MDD. “Over the past several months, we continued to advance our AXS-05 and AXS-07 product candidates towards NDA submissions in major depressive disorder and migraine, and intensified our commercial launch readiness activities,” reported Axsom CEO Herriot Tabuteau, MD.

Relmada Therapeutics Inc. (NASDAQ: RLMD) started trading in July 2020 on the Nasdaq Global Select Market. A clinical-stage company developing novel therapies for the treatment of CNS diseases, Relmada has a lead program focused on REL-1017 (dextromethadone), an N-methyl-D-aspartate (NMDA) receptor antagonist in development for the treatment of depression. NMDA receptor antagonists may have utility in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.

With drug development capturing significant investor interest and support, the timing couldn’t be better for companies intent on making a difference in the lives of millions of people who suffer from mental disorders.

For more information about Cybin, please visit Cybin Inc.

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