Sironax announced that the U.S. Food and Drug Administration designated its SARM1 inhibitor SIR2501 as a Fast Track product for chemotherapy-induced peripheral neuropathy, a common, nerve-damaging side effect of certain chemotherapies.
Fast Track designation can enable more frequent interactions with the agency, a rolling NDA or BLA review, and potential priority review and accelerated approval to expedite development and review for serious conditions with unmet need. The company claims SIR2501 is a first-in-class allosteric SARM1 inhibitor designed to maintain the enzyme in an inactive state to protect nerves while avoiding adverse effects seen with orthosteric inhibitors.
SIR2501 showed strong neuroprotective effects in multiple preclinical models and that global Phase 1b/2 clinical trials in CIPN and ALS are ongoing. Sironax, founded in 2017, also lists SIR4156 and SIR9900 among its development programs, and the designation highlights the unmet treatment need in CIPN.
