InFlectis BioScience received Orphan-Drug Designation from the U.S. Food and Drug Administration (FDA) for its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), IFB-088.
Nantes, France--(Newsfile Corp. - March 28, 2022) - InFlectis BioScience received Orphan-Drug Designation from the U.S. Food and Drug Administration (FDA) for its investigational treatment for Amyotrophic Lateral Sclerosis (ALS), IFB-088. In preclinical studies, IFB-088 has been shown to prolong the protective effect of the Integrated Stress Response, giving cells additional time to repair or eliminate mis-folded proteins that can result in diseases such as ALS. The Company plans to initiate a Phase 2 trial in Europe (France and Italy) this summer. Orphan drug designation provides for tax credits for qualified clinical trials and extended market exclusivity for up to seven years as a way to encourage companies to develop treatments for rare conditions.
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Key Takeaways:
- IFB-088 has been granted Orphan-Drug Designation from the FDA in the treatment of Amyotrophic Lateral Sclerosis (ALS).
- IFB-088 is a first-in-class small molecule thought to prolong the protective effect of the Integrated Stress Response, a pathway that prevents buildup of misfolded disease-causing proteins.
- InFlectis, who obtained authorization to start a phase 2 trial in Europe (France and Italy) in patients with bulbar-onset ALS, expects to enroll the first patient this summer before initiating a larger study in the US and worldwide.
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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 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.
InFlectis BioScience is a clinical stage company committed to the development of innovative therapeutics harnessing the Integrated Stress Response (ISR) for the treatment of a broad range of diseases. Based in Nantes in Western France, InFlectis BioScience is part of the science park of the economic area of Nantes Atlantique.
Contacts:
Philippe Guédat
philippeguedat@inflectisbioscience.com
Pierre Miniou
pierreminiou@inflectisbioscience.com
Francina Agosti, Ph.D.
francina@octaviant.com
Source: Inflectis
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