Nantes, France – May 15th, 2019
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 favorable results from the Single Ascending Dose (SAD) part of the Phase 1 trial (P188) that evaluated six single doses of IFB-088 administered by oral route. IFB-088, a selective inhibitor of stressed-induced PPP1R15A/PP1c phosphatase complex, is planned to be developed primarily for the treatment of Charcot-Marie-Tooth disease.
The SAD part of the double-blind, randomized, placebo-controlled Phase 1 trial evaluated the safety, tolerability and pharmacokinetics of six doses of IFB-088 in a total of 48 healthy volunteers. Results demonstrated IFB-088 to be well tolerated at doses ranging from 2.5 mg to 60 mg daily, with linear human pharmacokinetics over the dose range tested. IFB-088 was observed to show a favorable safety and tolerability profile with no serious adverse events at all doses tested within the trial.
Based on the favorable results of the SAD part, the Company is preparing to initiate the Multiple Ascending Dose (MAD) part of the Phase 1 study. The MAD will be conducted according to a double-blind, randomized, placebo-controlled, multi oral ascending dose design and will assess the safety, tolerability and pharmacokinetics of three doses of IFB-088 administered to healthy volunteers over 14 days.
Following the successful completion of the Phase 1 study planned by year end, InFlectis BioScience will transition the IFB-088 program into Phase 2 clinical trials to test the drug treatment in patients with Charcot-Marie-Tooth diseases 1A and 1B. Based on preclinical evidences and proofs of concept in CMT1A and CMT1B animal models, the European Commission and the Food and Drug Administration (FDA) have both already granted orphan drug designation (ODD) to IFB-088 for the treatment of Charcot-Marie-Tooth diseases. Additional preclinical data will be presented at Peripheral Nerve Society annual meeting in Genoa, Italy in June 2019 and will highlight the activity of IFB-088 as a potent and selective agent to improve the clinical signs of neuropathy in CMT1A and in CMT1B.
During the remainder of 2019, preparation for the phase 2 program of IFB-088 in Charcot-Marie-Tooth patients will also include a pre-Investigational New Drug meeting with the U.S. Food and Drug Administration and a Protocol Assistance with the European Medicines Agency to discuss the IFB-088 development strategy in CMT.
Last Updated: Thursday 15th August, 2019