Trial Profile
A phase II/III trial of MYCO-004 for Smoking Cessation
Status:
Planning
Phase of Trial:
Phase II/III
Latest Information Update: 12 Apr 2023
Price :
$35
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At a glance
- Drugs Psilocybin (Primary)
- Indications Smoking withdrawal
- Focus Therapeutic Use
- 31 Mar 2023 According to a Mydecine Innovations Group media release, the Company is donating the drug product for the NIDA trial and plans to have the MYCO-004 Phase II trial at JHU in lieu of the originally planned MYCO-001 trial, as part of the 5-year research collaboration agreement.
- 09 Jun 2022 According to a Mydecine Innovations Group media release, by separating single seamless trial into two, the company gain the advantage of making protocol adjustments between Phase 2b and Phase 3 and pushed 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.
- 09 Jun 2022 According to a Mydecine Innovations Group media release, based on feedback from the FDA during our pre-IND meeting in February, the company pivoted clinical trial strategy from a seamless Phase 2/3 design, to a Phase 2b and subsequent Phase 3 study. clinical trial strategy from a seamless Phase 2/3 design, to a Phase 2b and subsequent Phase 3 study. The company has increased the number of subjects in this trial and is optimistic that it will be considered a pivotal study by the FDA.