Mind Medicine (NEO: MMED) this morning issued a brief update related two products within its research pipeline. Firstly, the company has completed a meeting with the US Food and Drug Administration in relation to its LSD assisted therapy for anxiety. And secondly, Mindmed has completed analyzing preliminary data for its 18-MC phase 1 clinical study.
In terms of its LSD assisted therapy for the treatment of anxiety, the company has concluded its pre-investigational new drug meeting with the FDA. The meeting was said to be a success, with the company indicating that it intends to file an application for a new IND with the agency in August 2021. If approved, the IND would see the company conducted a phase 2b clinical trial to evaluate the use of LSD against anxiety.
Speaking to Project Layla, which is Mind Medicine’s ibogaine-derived formulation known as 18-MC, the company is said to have completed analysis of preliminary data for the planned addiction treatment program. Both the Single Ascending Dose study as well as the Multiple Ascending Dose study have reportedly demonstrated that the drug is safe and well tolerated at the current dosages test, with no serious adverse effects.
Dose escalation is as a result expected to continue for the 18-MC trials, and upon additional data being reviewed, the company will look to initiate a Phase 2a proof of concept study. The company has indicated that a meeting with the FDA has been confirmed to discuss the development of the drug.
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Mind Medicine last traded at $4.57 on the Neo Exchange.
Information for this briefing was found via Sedar and MindMed. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
