Report

IRLAB Therapeutics - Despite shift, mesdopetam still on track for Ph III

IRLAB has secured full global rights ownership of mesdopetam, the company’s leading asset, which was previously out-licensed to Ipsen. All preclinical studies and Phase I, Ib, IIa and IIb trials were completed as part of this collaboration. Full ownership, including associated intangibles and materials, will return to IRLAB in exchange for future (low single-digit) royalties on future product sales. With Ipsen’s support, IRLAB is preparing for an end of Phase II meeting with the FDA, which we view as a key inflection point. Irlab believes mesdopetam is Phase III-ready and the revised arrangement with Ipsen may provide more flexibility to better leverage its ongoing Integrative Screening Process (ISP) platform. Ipsen has supported the preparation for Phase III, including upscale manufacturing, and three Phase III-preparatory Phase I studies: a pharmacokinetic, a drug-to-drug interaction and a mass balance study.
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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