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.”
ABOUT IFB-088 (also known as Sephin1)
IFB-088 is a first-in-class orally available small molecule drug candidate with a validated mechanism of action and a promising pharmacokinetic profile for targeting the central and peripheral nervous system. IFB-088 improves protein homeostasis following a stress (e.g., misfolded protein accumulation, oxidative stress, etc.) activating the Unfolded Protein Response or the Integrated Stress Response observed in several neurodegenerative disorders, including CMT.
IFB-088 is targeting the stress-induced PPP1R15A/PP1c phosphatase complex involved in dephosphorylation of translation initiation factor eIF2α. Thus, IFB-088 regulates the protein translation rate in stressed cells to a level manageable by available cellular proteins that assist in protein folding (so-called “chaperones”), thereby restoring proteostasis. IFB-088 is strikingly specific for stressed cells, avoiding persistent inhibition of protein synthesis in normal, non-stressed cells.
ABOUT THE IFB-088 PHASE 1 P188 CLINICAL TRIAL
The Phase 1 P188 clinical trial, conducted in France, was a randomized, double-blind, placebo-controlled, single (SAD) and multiple ascending dose (MAD) study of IFB-088, designed to evaluate the safety, tolerability and pharmacokinetics of IFB-088 in healthy subjects. The study enrolled 72 adult male volunteers into 6 SAD cohorts of 8 subjects, with IFB-088 given orally as single doses ranging from 2.5 mg to 60 mg daily, and 3 MAD cohorts of 8 subjects, with IFB-088 given orally at doses ranging from 15 to 50 mg/day for 14 consecutive days.