InFlectis BioScience Announces Promising Results for IFB-088 in a Phase 2a Clinical Study in Bulbar-Onset ALS Patients
February 06, 2025 7:08 AM EST | Source: Reportable, Inc.
Nantes, France--(Newsfile Corp. - February 6, 2025) - InFlectis BioScience SAS, a drug discovery company pioneering development of therapeutics harnessing the Integrated Stress Response (ISR) for a spectrum of neurological diseases, today announced the successful completion of its P288ALS TRIAL study (NCT05508074). This study was designed as a randomized, double-blind, placebo-controlled, parallel-group phase 2a trial comparing its drug candidate IFB-088 (25 mg BID) plus riluzole with placebo plus riluzole, in patients afflicted with bulbar-onset ALS, a particularly severe ALS subtype.
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Key Takeaways:
- Promising results reported for IFB-088 in a Phase 2a clinical study in bulbar-onset ALS Patients.
- Biomarker evidence highlights IFB-088 impact on integrated stress response and oxidative pathways.
- These findings confirm the hypotheses raised from preclinical studies and strongly support the premise of moving IFB-088 to pivotal study.
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About IFB-088 (icerguastat)
InFlectis is developing IFB-088 (also named sephin1), a first-in-class, multi-functional, brain-penetrant, orally administered small molecule that selectively inhibits the dephosphorylation of eIF2. By doing so, IFB-088 amplifies the integrated stress response (ISR), acting as a formidable shield against various cellular stresses, including endoplasmic reticulum (ER) stress which is a hallmark of neurodegeneration. IFB-088 also selectively antagonizes NMDA receptors containing the NR2B subunit, which are involved in glutamate excitotoxicity that triggers calcium influx, mitochondrial dysfunction, and ROS production, and ultimately contributes to neurodegeneration. IFB-088 also reduces mitochondrial ROS production in an NMDAR-independent manner. Hence, IFB-088 normalizes dysregulated calcium homeostasis and oxidative stress to provide neuroprotection in different diseases context. This approach holds promise for designing disease-modifying therapeutics to fight intractable diseases such as ALS.
About Bulbar-Onset ALS
ALS is increasingly being recognized as a heterogeneous disease. To optimize assessment in a small study, InFlectis has focused IFB-088 development to date on bulbar-onset ALS patients, who account for ~30% of all ALS patients and represent a more homogeneous patient population. Bulbar ALS is a distinct phenotype identified with specific clinical parameters; disease onset primarily affects the brainstem, impacting muscles responsible for speech, swallowing, and limb functions. Patients experience slurred speech (dysarthria) and difficulty swallowing (dysphagia) early in the disease progression. Bulbar-onset ALS usually exhibits a rapid evolution and poor prognosis (~26 months from symptom onset to death). Treatment options remain a high unmet medical need for this patient group.
About the ALS ASSOCIATION
The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about the ALS Association, visit our website at als.org.
About AFM-T'el'ethon
The French Muscular Dystrophy Association (AFM) - AFM-Telethon - is a major player in biomedical research for rare diseases in France and worldwide. It currently funds about 350 research programs and 40 clinical trials in different genetic diseases affecting the eye, blood, brain, immune system, motor neurons and muscles... The AFM-Telethon has also created three research and development institutes dedicated to gene therapy, stem cells and myology. To learn more visit www.afm-telethon.fr/en
Source: Inflectis
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