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

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.

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/company/irlab-therapeutics

Länk till analysen i sin helhet: https://www.edisoninvestmentresearch.com/research/report/irlab-therapeutics362172/preview