MindMed (OTCMKTS:MMEDF) has announced the completion of a pre-Investigational New Drug (IND) meeting with the FDA for lysergic acid diethylamide (LSD) development as anxiety disorder therapy.
MindMed on a pathway to develop anxiety disorder therapy
This successful completion of the meeting with the FDA is a huge step for MindMed and it offers confidence and regulatory clarity as the company advances the clinical development program. The company is planning to open the IND in August 2021 with the Phase 2b clinical study to evaluate experiential LSD doses in anxiety disorder.
J.R Rahn, the company’s Co-CEO and Co-Founder said that the FDA is among the most impactful agencies for regulated drug development globally. Rahn said that MindMed is looking forward to working with the FDA on a psychedelic-assisted therapies pathway in compliance with guidelines. He added that the company plans to commence its Phase 2b study for Project Lucy in 2021.
MindMed has also provided preliminary analyzed data for its addiction treatment program assessing the ibogaine derivative 18-MC that the company named Project Layla. According to preliminary Phase, 1 Single Ascending Doses (SAD) and Multiple Ascending Dose (MAD) studies data the drug was well tolerated and safe at the doses that the company has tested so far without any serious adverse events. Based on these encouraging results the company has indicated that it will continue to dose escalation to collect higher dosing data. After a review of additional data, the company will commence Phase 2a proof of concept study.
MindMed completes short term prospectus
Recently the company announced the filing of a short form prospectus with the Canadian securities commissions in all provinces except Quebec further to its previously announced offering. According to the restated and amended agreement, Canaccord Genuity Corp the lead underwriter, and CIBC Capital Markets have agreed to buy 18.2 million units of MindMed. They will purchase the units on a bought deal basis at CAD$4.4 per unit for total proceeds of around CAD$80.08 million. MindMed also granted them an over-allotment option to buy another 15% of the units.