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Inflectis Bioscience receives approval from French regulatory authority to conduct a Phase 2 Clinical Trial for IFB-088 for ALS

01/10/2022
InFlectis Bioscience SAS, one of the Remiges' portfolio companies, developing orally available small molecule agents for neuromuscular diseases by harnessing the Integrated Stress Response (ISR), receives approval from the French Regulatory Authority ANSM to start a Phase 2 clinical trial evaluating IFB-088 for the treatment of Amyotrophic Lateral Sclerosis (ALS). The study is a double-blind, placebo-controlled, exploratory randomized clinical trial to assess the safety and efficacy of IFB-088 plus riluzole 100 mg, vs placebo plus riluzole 100 mg in patients with bulbar-onset ALS.

IFB-088 will be administrated orally two times a day (morning and evening uptakes) during six months in combination with riluzole, an approved drug for treating ALS in Europe. Safety will be monitored over the course of the study by a data and safety monitoring board. A minimum of 42 patients will be recruited, 28 receiving IFB-088 and 14 receiving placebo. The study principal objectives consist of assessing the safety of IFB-088 in patients with bulbar-onset ALS, and its efficacy at 50 mg/day plus riluzole 100 mg/day versus placebo plus riluzole 100 mg/day over a 6-month period.

This Phase 2 study will be conducted in France and Italy. InFlectis submitted the Clinical Trials Application (CTA) to the Italian Medicines Agency (AIFA) and is awaiting the approval.

IFB-088 safety has been tested in a Phase 1 clinical trial in 72 healthy volunteers. This randomized, double-blind, placebo-controlled, single- and multiple-dose (SAD and MAD) escalation study demonstrated that administration of IFB-088 was safe and well tolerated in adult male volunteers. No serious adverse events, dose-limiting toxicities, or clinically significant abnormalities were observed in 6 SAD cohorts of 8 subjects, with IFB-088 given orally as single doses ranging from 2.5 mg to 60 mg/day, and in 3 MAD cohorts of 8 subjects, with IFB-088 given orally at doses ranging from 15 to 50 mg/day for 14 consecutive days.

About IFB-088 (INN: Icerguastat)

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 targets the PPP1R15A/PP1c phosphatase complex, which is associated with ISR resolution and inflammation among the various ISRs induced by cellular stresses including endoplasmic reticulum stress and mitochondrial stress. IFB-088 acts specifically on stressed cells, by targeting the stress-induced PPP1R15A/PP1c phosphatase complex, and has a therapeutic effect by prolonging ISR regulating the protein translation rate in stressed cells to a level manageable by available cellular proteins, activating autophagy and other cell protective pathways associated with amelioration of endoplasmic reticulum stress and mitochondrial stress. IFB-088 is strikingly specific for stressed cells, avoiding persistent inhibition of protein synthesis in normal, non-stressed cells.