Report

IRLAB Therapeutics - Mesdopetam’s clinical roadmap laid out

IRLAB has submitted a request for an end-of-Phase II meeting (EoP2) with the FDA for its lead asset, mesdopetam, to chart the Phase III roadmap for the drug. According to FDA guidelines, the agency intends to respond to such requests within 14 days and schedule a meeting within 70 calendar days from the receipt of the request. We see the EoP2 meeting as an important inflection point for IRLAB to continue clinical development of mesdopetam after securing full ownership rights from Ipsen in August 2023. Management met a key efficacy secondary endpoint and the drug has shown dose-dependent anti-dyskinetic and anti-Parkinsonian effects, which support continued development, in our view. Our valuation currently assumes a 40% probability of success for mesdopetam in levodopa-induced dyskinesias (PD-LIDs) and we plan to revisit our assumptions following the results from the FDA meeting.
Underlying
IRLAB Therapeutics

IRLAB Therapeutics AB is a Sweden-based research and development company. It focuses on illnesses in the central nervous system and primarily on development of drugs to assist patients with Parkinson's disease. The Company possesses a research platform Integrative Screening Process (ISP), which aims to discover and develop drug candidates for the treatment of brain diseases. The Company operates projects on both clinical phase and preclinical phases. The primary projects are IRL790 and IRL752, both on clinical phase. The IRL790 project is a psychomotor stabilizer for the treatment of levodopa (L-dopa) amino acid that dyskinesia induces in Parkinson's Disease (PD-LIDs) and Parkinson Disease psychosis (PD-Psychosis). The IRL752 project aims at cortical enhancement for the treatment of Parkinson Disease Dementia (PD-D) and Behavioral and Psychological Symptoms of Dementia (BPSD).

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Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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