Results show IFB-088 is safe and well tolerated in healthy volunteers Data supports initiation of Phase 2 trial in Charcot-Marie-Tooth disease
January 7, 2020
Nantes, France – InFlectis BioScience SAS, a drug discovery company committed to the development of innovative therapeutics harnessing the Integrated Stress Response for the treatment of a broad range of diseases, today announced the results of its Phase 1 study of IFB-088, an oral small molecule targeting the stress-induced PPP1R15A/PP1c phosphatase complex, in 72 healthy volunteers. Results of this randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study (SAD/MAD) demonstrated that administration of IFB-088 was safe and well tolerated. No serious adverse events, dose-limiting toxicities, or clinically significant abnormalities were observed. The pharmacokinetic parameters were consistent with data derived from extensive studies in animal models.
Anne Visbecq, Chief Medical Officer of InFlectis BioScience SAS, said: “We are very pleased with the outcomes of the IFB-088 Phase 1 trial, which confirm the good tolerance profile of IFB-088 even in high dose groups. No safety concern has been identified and pharmacokinetics were as expected.”
“Results from this study provide the first clinical data for IFB-088 and creates a path forward for its evaluation as a potential first-in-class oral therapeutic treatment of CMT disease,” commented Philippe Guédat, Ph.D., President and Chief Executive Officer, InFlectis BioScience. “We look forward to working towards a U.S. and EMA IND filing in the coming months.”