Final Data Report: Eloxx Touts Improved Lung Function For Cystic Fibrosis Candidate

Eloxx Pharmaceuticals Inc ELOX announced the final data assessment from the Phase 2 trial of ELX-02, the company's lead investigational product candidate.

ELX-02 was tested in combination with ivacaftor with Class 1 Cystic Fibrosis patients.

The assessment includes a reanalysis using a change in ppFEV1 from Day 1 instead of baseline. Multiple patients experienced disease progression between screening and treatment.

ELX-02 demonstrated clinically relevant improvement in ppFEV1, a standardized assessment to evaluate lung function. 

Initial topline results from this trial were reported last September.

The ELX-02 combo was well tolerated, but did not achieve statistical significance for efficacy endpoints.

Results from the final analysis of 13 patients evaluable versus 11 at the time of initial assessment are summarized below:

Six of 13 patients entered the trial from the monotherapy arm and had a decrease in lung function (annualized -4.26% reduction in ppFEV1) due to disease progression.

Treatment with ELX-02 stabilized disease overall and resulted in a clinically relevant increase in ppFEV1 in six of thirteen patients based on a change in ppFEV1 at the end of treatment at Day 35 compared to the start of treatment at Day 1.

Topline data previously confirmed biological activity. Patients with higher baseline sweat chloride levels had increased responses to treatment as indicated by sweat chloride concentration.

ELX-02 was generally well tolerated in the trial. No treatment-related serious adverse events were noted.

Price Action: ELOX shares are up 2.44% at $7.15 during the premarket session on the last check Thursday.