- Mydecine recently reported a positive Pre-IND meeting with the FDA for the MYCO-001 smoking cessation study
- According to the Center for Disease Control (“CDC”), tobacco is the leading cause of preventable deaths in the U.S.
- Following the FDA meeting, the company now intends to perform a Phase 2b study and then a Phase 3 study instead of a seamless Phase 2/3 clinical trial
- Mydecine plans to submit a request for breakthrough therapy status with its IND submission
Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) has continually taken steps toward fulfilling its mission to become a trusted source of safe and effective medication-based treatments for mental health and addiction disorders by developing drug candidates, partnering to advance research, and more.
Under the stewardship of Dr. Matthew W. Johnson, Ph.D., a Professor of Psychiatry and Behavioral Sciences at the Johns Hopkins University (“JHU”) contracted last September (https://ibn.fm/SnsIY), for example, Mydecine plans to conduct a placebo-controlled study evaluating the science and efficacy of MYCO-001, its lead psilocybin-based drug candidate, in treating nicotine dependence, subject to the fulfillment of certain conditions, including a Pre-Investigational New Drug (“IND”) meeting with the Federal Drug Administration (“FDA”) as well as successful IND and breakthrough therapy status submissions.
Most recently, Mydecine reported a positive Pre-IND meeting held on February 28 (https://ibn.fm/Ze5ci). Following this meeting, the company has decided to undertake a Phase 2B study and then a Phase 3 study instead of the initial approach wherein it intended to conduct the study as part of a seamless Phase 2/3 clinical trial. The company’s new approach of separating the trials enables them to publish data after each study rather than waiting until both phases are complete.
“We had an extremely positive meeting with the FDA in regards to our proposed smoking cessation study. The FDA provided helpful feedback on our study design that we will implement,” commented Mydecine CEO Josh Bartch in a March 1 news release. “We are now working rapidly in preparing our IND submission of the 2B portion of the study, which we believe will be next month. Once cleared, we will move swiftly into patient recruitment.”
In addition to the positive feedback, Mydecine also highlighted its plans to submit a request for breakthrough therapy designation with its IND submission. According to the company, psilocybin-assisted treatment has shown marked advantages over available therapies for tobacco addiction, including a substantial increase in safety and efficacy. Data from JHU’s ongoing studies, in fact, show that psilocybin-assisted treatments are 2-3 times more effective in treating nicotine addiction than existing treatments.
With the Center for Disease Control (“CDC”) stating that tobacco use is the leading cause of preventable death in the United States (https://ibn.fm/t2lwh), a breakthrough designation could go a long way in remedying the situation. Equally, Mydecine’s Phase 2B and Phase 3 trials could provide the data needed to support this goal.
According to Bartch, Mydecine has worked on the proposed smoking cessation study over the last two years and has even partnered to move its R&D forward. For instance, last August, Mydecine signed a five-year master collaboration research agreement with the JHU School of Medicine. Under the terms of the partnership, Dr. Johnson would spearhead research on the therapeutic use of psychedelics. This agreement would allow JHU and Mydecine to further advance research on novel psychedelic-based therapies for mental health conditions and addiction disorders (https://ibn.fm/UUpvC).
Mydecine announced MYCO-001, composed of 99% pure psilocybin, early last year. The company intends to administer MYCO-001 as a possible treatment for post-traumatic stress disorder (“PTSD”) as well as nicotine addiction and is, in fact, the only biotech company targeting smoking cessation as an indication. Its planned clinical trials will build off Dr. Johnson’s ongoing research, which has evidenced an 80% efficacy rate at six months (https://ibn.fm/dIsLY).
For more information, visit the company’s website at www.Mydecine.com.
NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF
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