Late last summer, Mydecine made headlines with the announcement of a major new trial using their MYCO-001 compound for smoking cessation. The study is a collaboration with the Johns Hopkins psychedelic research group, run by Dr. Matthew Johnson, a world leader in the field. It was an important step forward and we’ve been waiting for updates ever since.
Today the company reported the IRB (Institutional Review Board) has approved its Phase 2b study, paving the way for the next major step (FDA approval of its IND or Investigational New Drug application).
A good bit of news. Mydecine plans to submit the IND application in Q2 2022, hoping it will go into effect 30 days after submission. According to the press release (see below), “the Company will move rapidly into the patient recruitment phase upon FDA clearance. Mydecine’s Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as Q4 2023.”
This continuing pushing forward of their lead programs is extremely important. With advanced trials in the works on a huge indication like smoking addiction, and collaborations with top names like Johns Hopkins and Dr. Johnson, Mydecine has to keep the pedal to the metal. In tenuous times like these, with market prices hitting historic lows, supporters and investors need to be reminded of the potential — to both help people and offer serious returns.
With prices this depressed (Mydecine opened today at a very dainty $0.105) we need to keep the hope alive until the market can recover, and it’s announcements like these that will help retain confidence in the long term vision.
With this said, we’re anxiously waiting for Mydecine’s next capital raise. The firm has impressive potential but is running dangerously low on cash. The company secured a much-needed $5.5 million in financing back in December but something more significant is required.
We’ll let you know as soon as there’s news.
Mydecine Receives Conditional IRB Approval for Phase 2b Smoking Cessation Study
Clinical trial programs advance to further assess psychedelic-assisted psychotherapy utilizing lead drug candidate MYCO-001
March 24, 2022 07:30 ET | Source: Mydecine Innovations Group Inc.
DENVER, March 24, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced it has received conditional approval from the Institutional Review Board (IRB) for its multi-site Phase 2b smoking cessation trial. Johns Hopkins University will serve as the lead investigational site.
The Company reported the IRB has approved its Phase 2b smoking cessation study pending FDA approval of its Investigational New Drug (IND) application. Mydecine plans to submit the IND application in Q2 2022 and is hopeful it will go into effect 30 days after submission.
“We are beyond excited to share the news of our conditional IRB approval for our Phase 2b clinical trial. Upon the near-term clearance of our IND application, which is wholly owned by Mydecine, we will be the first commercial IND approved utilizing psilocybin for the indication of smoking cessation, and one of a small number of organizations with a commercial FDA IND approval, alongside COMPASS Pathways, MindMed, and Usona, for a Phase 2 or later stage study assessing a psychedelic compound for any indication. We have a strong patent and regulatory strategy to support this initiative as well as further subsequent approvals,” said CEO Josh Bartch.
“This conditional approval marks a significant milestone not only for Mydecine but for people around the globe. The total economic cost of smoking has been estimated to be more than $300 billion
per year in the United States alone. Our mission is to bring safer, more effective solutions to address nicotine dependence and other harmful addictions. This conditional approval brings us one step closer to potentially having a positive effect on millions of lives utilizing this innovative treatment program,” said Mydecine’s Chief Medical Officer Dr. Rakesh Jetly.
“Today’s accomplishment speaks to the perseverance and dedication of our team as we continue to build on our clinical and commercial potential,” added Mydecine’s Senior Director of Clinical and Regulatory Affairs Jessica Riggleman. “Our success is built upon a strategic collaboration between our contract research organization, manufacturer, investigators, advisors and regulatory consultants. We are diligently working together to submit our Investigational New Drug Application to the FDA for our multi-regional Phase 2b clinical trial.”
The Company will move rapidly into the patient recruitment phase upon FDA clearance. Mydecine’s Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as Q4 2023.
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About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.
Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, YouTube and Instagram.
For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com
Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com
For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.
