Nantes, France, December 19, 2022: InFlectis BioScience SAS, a clinical-stage company developing innovative therapeutics for neuromuscular diseases by harnessing the Integrated Stress Response (ISR), dosed the first patient with IFB-088 in combination with riluzole as part of the phase 2 clinical trial for the treatment of bulbar-onset Amyotrophic Lateral Sclerosis (ALS), a rare neurological disease with no curative treatment to date.
“Dosing the first patient represents an important step toward developing a new treatment to potentially slow progression in the bulbar-onset population of ALS patients by modulating the ISR,” said Philippe Guédat, Ph.D., Founder, President, Chief Executive Officer of InFlectis BioScience. “We look forward to completing enrollment across 17 trial sites in Italy and France and reporting our findings as expeditiously as possible.”
The study, named TRIALS (Treatment combining Riluzole and IFB-088 in bulbar Amyotrophic Lateral Sclerosis), is a double-blind, placebo-controlled, exploratory randomized clinical trial to assess the safety and efficacy of IFB-088 plus riluzole, vs placebo plus riluzole in patients with bulbar-onset ALS. IFB-088 will be administrated orally two times a day for six months in combination with riluzole, a drug approved in Europe for treatment of ALS.
The TRIALS study is supported in part by AFM-Téléthon, a patient organization fighting rare neuromuscular diseases. The Principal Investigator in France is Prof. Shahram Attarian from Hospital La Timone in Marseille while the Principal Investigator in Italy is Prof. Giuseppe Lauria from the Istituto Neurologico Carlo Besta, Fondazione IRCCS, in Milan.
Bulbar-onset ALS accounts for approximately 25 to 30% of patients diagnosed with ALS and it is the most aggressive form of the disease with a shorter life expectancy compared to spinal-onset ALS. It is characterized by difficulties in chewing, swallowing or speaking as initial signs and symptoms.
About the TRIALS study
This phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group will enroll 50 patients diagnosed with bulbar-onset ALS, aged 18 and older. Study participants will receive study treatment on top of riluzole (standard of care). The primary endpoint for the study will be safety and tolerability. Secondary endpoints will include efficacy and biomarkers.
“We are pleased to have dosed the first patient in the TRIALS study, which will inform on the potential role of IFB-088 for the treatment of bulbar-onset ALS,” said Anne Visbecq, M.D., Chief Medical Officer of InFlectis BioScience. “Results expected by the end of Q1 2024 will provide the first proof of concept for the therapeutic potential of IFB-088.”
For additional information about the TRIALS study and to learn more about eligibility, patients can visit https://clinicaltrials.gov/ct2/show/NCT05508074.
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 capable of crossing the blood brain barrier to target the central and peripheral nervous system. IFB-088 acts on the ISR by targeting the stress-induced PPP1R15A/PP1c phosphatase complex and regulating the protein translation rate in stressed cells to a level manageable by available cellular proteins that assist in protein folding. IFB-088 is strikingly specific for stressed cells, avoiding persistent inhibition of protein synthesis in normal, non-stressed cells.