Eloxx Pharmaceuticals Inc (NASDAQ: ELOX) posted topline results from the monotherapy arms of its Phase 2 trial of ELX-02 in Class 1 cystic fibrosis patients with at least one G542X nonsense allele mutation.
Eloxx delivered one-week ELX-02 data on 12 people with a G542X nonsense mutation who received ELX-02 at 1.5 mg/kg/day.
Sweat chloride, a biomarker of cystic fibrosis, fell by 5.4 mmol/L in recipients of ELX-02, causing the trial to meet one of its key secondary endpoints.
However, there was no change in lung function as measured by FEV1.
Eloxx attributed the missed FEV1 secondary endpoint to the short duration of the clinical trial.
The primary endpoints looked at safety and pharmacokinetics.
Eloxx said other groups did show short-term reductions in sweat chloride translate to long-term improvements in lung function.
Eloxx has begun dosing in a Phase 2 expansion arm, evaluating ELX-02 in combination with Vertex Pharmaceuticals Incorporated's (NASDAQ: VRTX) Kalydeco, putting it on course to deliver data in 1H of 2022.
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