Mydecine Provides Company Update; Welcomes New Board Member
Mydecine Innovations Group (NEO: MYCO)(OTCMKTS: MYCOF), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today provided an update on clinical trial and drug development initiatives, and appointed a new member to its Board of Directors.
As we near the end of the second quarter, I’m proud of the progress our team has made despite the volatile and uncertain market conditions. Our focus remains on creating value for our shareholders by focusing on efforts to set Mydecine up for future success. We believe our recent consolidation will make the company’s share position more appealing to a broader range of investors moving forward; as well as face less resistance in the positive movement of the stock price. We have significantly decreased our burn rate since Q4 2021, in order to have sufficient capital available to meet our next clinical trial and drug development milestones.Mydecine CEO Josh Bartch
Mydecine closed two separate financings in May 2022 for a total of $4.5 CAD in gross proceeds to the company.
The Company also announced today the appointment of Todd Heinzl to its board of directors to replace Independent Director, Gordon Neal. Mr. Heinzl holds over 30 years of experience in the investment, merchant banking, and financial services industry. Mr. Heinzl’s expertise centers around assisting globally minded small and mid-cap companies by developing adequate corporate governance policies.
Clinical Trial Update
“Based on feedback from the FDA during our pre-IND meeting in February, we’ve pivoted our clinical trial strategy from a seamless Phase 2/3 design, to a Phase 2b and subsequent Phase 3 study,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly. “We have increased the number of subjects for the Phase 2b trial and are optimistic that it will be considered a pivotal study by the FDA. By separating our single seamless trial into two, we also gain the advantage of making protocol adjustments between Phase 2b and Phase 3. This pivot has pushed our trial timeline slightly; however, it allows us to publish clinical data after the Phase 2b study rather than waiting for the entire Phase 2/3 study to be completed and could ultimately increase our speed to market.”
The Company plans to submit full Breakthrough Therapy Status and Investigational New Drug applications in early Q4 2022 and hopes to gain full clearance within 30 days after submission.
Drug Development Update
In January, Mydecine announced it completed a target based 5-HT2A model for its artificial intelligence (AI) and machine learning (ML) drug discovery program. Today the Company shares that it has completed the 5-HT2B model and intends to develop the entire family of serotonin receptors.
“As we continue to complete more target based models for our AI program, we exponentially increase our ability to produce viable drug candidates and diversify our molecule portfolio with long term treatment options that can reduce known risks. Mitigating the risk of valvulopathy due to long term activation of the 5-HT2B receptor, which is linked to heart valve disease, is one example,” said Chief Scientific Officer Rob Roscow.
Past research has shown there is strong correlation between binding to the 5-HT2B receptor and heart valve tissue fibrosis. By filtering its lead drug candidates against both receptor models, the Company can more efficiently filter out drug candidates that have strong binding affinity to the 5-HT2A receptor but weak or no binding to the 5-HT2B receptor. This process leads to increased likelihood of desired outcomes.
“Our lead drug candidates are showing strong promise in receptor selectivity. Preclinical data of our new chemical entities (NCEs) continues to support our initial hypothesis that these new families of molecules are safer and offer more control than the first generation psychedelic compounds. Our NCE program continues to gain interest from groups in the psychedelic space, who are specifically excited about our psilocin prodrugs, as we believe they offer a very quick regulatory pathway,” Roscow added.
The Company’s AI-driven drug discovery program is led by Principal Investigator Dr. Khaled Barakat out of the University of Alberta. The University of Alberta is ranked top 3 globally for AI research and considered Canada’s number one Computing Science Department.
Learn more about Mydecine’s drug development efforts by clicking here.
To view the original press release in its entirety click here