Savvy Companies Making Moves in Drug-Development Space

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Nov 12, 2020, 08:30 ET

NEW YORK, Nov. 12, 2020 /PRNewswire/ -- Drug development means big money these days as big pharma and life science companies work to discover treatments that make a difference in the world. Investors are showing strong interest in the drug-development industry, and savvy companies are also making strategic M&A moves to strengthen their positions in the growing space. Life sciences company Cybin Inc. (NEO: CYBN) (Cybin Profile) exemplifies what is happening. The company, which focuses on developing psychedelic therapeutics along with unique delivery mechanisms that target depression as well as other psychiatric and neurological condition, just completed a reverse takeover. Other announcements in the drug-development space also shine a spotlight on the action taking place in this dynamic sector. Johnson & Johnson (NYSE: JNJ) just completed the acquisition of Momenta Pharmaceuticals Inc. H. Lundbeck AS ADR (OTC: HLUYY) finalized its acquisition of Alder BioPharmaceuticals, a company committed to transforming migraine treatment and prevention. Karuna Therapeutics Inc. (NASDAQ: KRTX) executed an underwritten public offering of 2,600,000 shares of its common stock, and Sage Therapeutics Inc. (NASDAQ: SAGE) hosted an exclusive event to discuss its research and development strategy as well as provide clinical progress in its key programs.

Company's reverse takeover forms publicly traded company focused on psychedelic therapeutics.
Groundbreaking research reports that psilocybin treatment had "more than four times greater effect" than typical antidepressant medications.
Multiple studies and trials create strong Cybin pipeline.

Click here to view the custom infographic of the Cybin editorial.

An Innovative Public Company

Significant amounts of money are being invested in the drug-development sector, and Cybin Inc. (NEO: CYBN) could see significant benefits. The leading life sciences company recently completed a reverse takeover, and just this month, Cybin start trading common shares on the NEO exchange under the symbol CYBN.

Cybin management notes that the reverse takeover of Clarmin Explorations Inc. will result in an innovative public company focused on psychedelic drug development, unique delivery mechanisms, and improved novel compounds and protocols that could 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."

Previously Cybin announced the closing of a private placement offering resulting in aggregate gross proceeds of CDN$45 million. The company intends to use the net proceeds from this offering to 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.

An Enormous Unmet Need

Depression is often a little-discussed secret, but it is estimated that more than 17 million adults in the United States alone experienced at least one major depressive episode last year, and one out of every four people struggle with a diagnosable mental disorder. The need for treatment options is clear. Cybin is committed to finding answers to address this enormous unmet medical need. The company is working to become the first life sciences company to bring an effective psilocybin therapeutic drug to market targeting major depressive disorder (MDD).

Earlier this month, an article in the journal JAMA Psychiatry reported the remarkable findings of a study featuring the hallucinogen psilocybin, which appears to support Cybin's efforts. During the study, 27 patients received two doses of psilocybin on different days and also received more than 10 hours of psychotherapy. The group was divided into two groups, with one group receiving treatment immediately while the second group waited for a period of time. The research team reported that the psilocybin treatment had an effect "more than four times greater" than the typical antidepressant medications.

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

"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.

Game-Changing Advancements

In the JAMA article, the author stated the need for additional research and study on all aspects psilocybin in order to confirm the results. Those efforts are well underway at Cybin. The company has already entered into a feasibility agreement with IntelGenx Corp. for the development of a sublingual film for the delivery of pharmaceutical-grade psilocybin. The results of partnership could lead to game-changing advancement not only for the delivery of psilocybin therapeutics but also for treatments of other types 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 [sublingual] psilocybin film is expected to be quite high," said Cybin chief medical officer, Jukka Karjalainen MD. "Additionally, the dose of psilocybin administered by a [sublingual] 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."

The agreement with IntelGenx is one of the several clinical trials and studies in the company's rapidly growing pipeline. Other trials and studies include the following:

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 a sublingual film, with further studies leveraging a transdermal, "slow-dose" delivery mechanism.

An innovator with expertise in one of the most promising options for mental disorders, Cybin appears to be moving forward quickly in the research and development space.

The Pursuit of Treatments

Other companies are joining Cybin in the pursuit of more effective treatments to provide help to those suffering from all types of illnesses and disorders. In doing so, these companies are making strategic moves to increase their funding and strengthen their portfolios.

Johnson & Johnson's (NYSE: JNJ) acquisition of Momenta Pharmaceuticals Inc. broadens the leadership of Janssen Pharmaceutical Companies in the autoimmune diseases space. The move also provides a major catalyst for sustained growth. "We're delighted to welcome Momenta's talented team to the Janssen Pharmaceutical Companies of Johnson & Johnson and to begin our work together to further advance patient care in autoantibody-driven diseases," said Jennifer Taubert, executive vice president and worldwide chairman of pharmaceuticals for Johnson & Johnson. "We anticipate multiple launches, many of which would be first-in-class indications in rare diseases and areas of significant unmet need."

In a move designed to enhance its brain-disease therapy options, H. Lundbeck AS ADR (OTC: HLUYY) acquired Alder BioPharmaceuticals. Alder brings eptinezumab to the table. Eptinezumab is an investigational monoclonal antibody (mAb) that is administered as a quarterly 30-minute IV infusion. The transaction should significantly accelerate and strengthen the build of Lundbeck's pipeline. Alder submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab last year, and the FDA approved Vyepti(TM) (eptinezumab-jjmr) as the first and only intravenous preventive treatment for migraine in February of this year.

A clinical-stage biopharmaceutical company, Karuna Therapeutics Inc. (NASDAQ: KRTX) late last year announced a public offering of common stock. Karuna is committed to developing novel therapies with the potential to transform the lives of people with disabling and potentially fatal neuropsychiatric disorders and pain. The company is working to deliver more effective and better-tolerated treatments for large and underserved patient populations. Its lead product candidate, KarXT, is under development as an investigational treatment for schizophrenia and dementia-related psychosis.

Sage Therapeutics Inc. (NASDAQ: SAGE) provided an innovative look at its research and development strategy during its September 2020 "FutureCast: An R&D Portfolio Review." The program also provided an overview the company's progress in its key depression, neurology, and neuropsychiatry franchise programs. "The team at Sage continues to follow the science with a fundamentally different approach, using our strong medicinal chemistry and focus on translational data to efficiently approach drug development," said Sage CEO Jeff Jonas, MD. "We continue to focus on areas where our early clinical data suggest the potential for meaningful patient benefit, not just incremental change."

A focus on drug development and meeting the needs of an underserved and suffering population looks to be a promising place to be.

For more information about Cybin, please visit Cybin Inc.

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