NFlection Therapeutics’ NFX-179 Gel Demonstrates Safety and Significant Reduction in p-ERK, a Key Biomarker Driving Neurofibroma Tumor Growth, in Positive Data From a 28-Day Phase 2a Clinical Trial
Excerpt from the Press Release:
WAYNE, Pa., May 26, 2021 /PRNewswire/ — NFlection Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on the development of targeted therapies for rare disorders driven by aberrant activation of the RAS pathway (RASopathies), today announced positive results from a 28-day, Phase 2a, multicenter, randomized, double-blind, parallel-group, vehicle-controlled clinical trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of NFX-179 Gel in subjects with NF1. Topical application of NFX-179 Gel is designed to deliver a proprietary “soft” (metabolically labile) MEK inhibitor to cNF tumors to suppress the overactivation of the Ras/Raf/MEK/ERK pathway in these tumors while avoiding the systemic toxicities of orally administered MEK inhibitors, which have not been approved for this indication.
In the trial, 48 subjects were randomized in a 1:1:1:1 ratio to receive once-daily NFX-179 Gel at 0.05%, 0.15%, or 0.5%, or placebo (vehicle), for 28 days. The primary endpoints were safety, tolerability and suppression of p-ERK, a key biomarker known to promote the growth of cNF tumors.
NFX-179 Gel was well tolerated. No serious adverse events were reported, and no adverse events were classified as related to NFX-179 Gel. All adverse events were mild to moderate and occurred at similar frequencies in the treatment and vehicle groups. Orally administered MEK inhibitors have common adverse effects of rash, diarrhea, peripheral edema and fatigue. Unlike systemic MEK inhibitors, which can cause severe acneiform rash, acneiform rash was not observed during treatment with NFX-179 Gel. Forty seven of the 48 subjects completed the trial; one subject withdrew from the trial due to COVID-19 infection.
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