Restore Mind Medicine
Categorical Failure of MM-110 Program
2015
The FDA stated that key preclinical safety trials were
required prior to initiating human trials in MM-110 but
FDA allowed the use of low doses in patients pending
completion of the preclinical safety studies.
As mice were dying at human-equivalent
dose of 20 mg.
Jan 2021 - June 2021
While Barrow was CDO, the MM-110 trial was
amended to allow dosing of patients at doses of
upwards of 1,200 mg.
April 2020
Dr. Freeman started a low-dose (<20 mg) Phase I trial into
MM-110 and left MindMed while dosing was at 8mg.
Jan 2022
MindMed announced its Phase I MM-110 trial was completed. In this
trial, MindMed dosed patients at over 660 mg - more than 35x
higher than the dose allowed by the FDA without the required safety
studies, which were never completed.
Source: Company SEDAR Filings, Company SEC Filings, MindMed Press Releases, Clinical trials.gov. See [3]
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