IRLAB communicated today that it has completed all the IRL757 preclinical studies and development work needed to start a Ph 1 trial in apathy in Parkinson's Disease and other neurological disorders. The company is currently preparing a Ph 1 clinical trial application (CTA) to be submitted to regulatory authorities. IRLAB also communicated today that The Michael J. Fox Foundation for Parkinson's Research (MJFF) has awarded a grant amounting to over USD 2m to IRLAB to support the Ph 1 study of IRL757 in apathy.
Mesdopetam's EOP2 meeting requested to the FDA
On a separate note, IRLAB announced on Monday that it has submitted a request for the end-of-Ph 2 (EOP2) meeting with the FDA for mesdopetam in PD-LIDs. The FDA is expected to respond to the request within 14 calendar days and schedule the meeting within 70 calendar days from receipt of the meeting request, therefore we expect the meeting to take place in Q1'24e. In the EOP2 meeting, the FDA will review mesdopetam's safety/tolerability, as well as evaluation of the plans for proceeding into a Ph 3 development. Beyond this, the other important near-term milestone is the data of the Ph 2b study in PD-falls with pirepemat, expected in Q2'24e.
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