N30 Pharmaceuticals, Inc. ("N30 Pharma") announced today that it has begun oral dosing of N91115 in a Phase 1 clinical trial. N91115, a novel inhibitor of S-nitrosoglutathione reductase (GSNOR), is being developed for the treatment of cystic fibrosis (CF). In preclinical studies, N91115 has been shown to rescue or "correct" F508del-CFTR, the most commonly occurring mutation in CF. It is the first oral GSNOR inhibitor to enter clinical development, and represents an important step forward in the development of more effective treatments for this serious disease.
The randomized, double-blind, placebo-controlled, Phase 1 study of orally administered N91115 will evaluate the safety, tolerability and pharmacokinetics of multiple ascending doses in healthy volunteers. The trial will assess several dose levels in up to 40 healthy adults.
N30 Pharma is also conducting a multicenter, dose escalation, safety study of N6022, its intravenous GSNOR inhibitor, in patients who are homozygous for F508del-CFTR. That study is currently enrolling the final cohort, at the highest dose, with completion expected in the second quarter of this year.
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