IRLAB Therapeutics - Mesdopetam Phase IIb top-line data
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). The drug did not meet the primary outcome of the study, change in daily hours of ‘ON time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia compared to placebo with statistical significance. However, the results confirmed the safety and tolerability of mesdopetam and met the secondary efficacy endpoint in demonstrating significant anti-dyskinetic effects as measured by the Unified Dyskinesia Rating Scale (UDysRS), a clinically recognised scale for measuring dyskinesias. We believe the importance of the secondary endpoint should not be overlooked; FDA approval of Gocovri in PD-LID was based on two pivotal studies assessing changes in the UDysRS as the primary outcome, demonstrating its clinical relevance. IRLAB’s stock dropped c 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development. Based on this news, our valuation and estimates are under review.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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