Lux Biosciences reports positive results for phase 3 uveitis therapy clinical program

JERSEY CITY, N.J. — Based on positive integrated safety profile results from Lux Biosciences' three phase 3 clinical trials of voclosporin, a twice daily 0.4 mg/kg dosing regimen of the drug appears suitable for treating chronic noninfectious uveitis, the company announced in a press release.

Previously called LX211, Luveniq (voclosporin) is an oral form of a next-generation calcineurin inhibitor for treating various forms of non-infectious uveitis that require systemic treatment, including posterior, intermediate and panuveitis. The drug, which is a corticosteroid-sparing agent, allows for the tapering of systemic corticosteroids to 5 mg or less per day, the release said.

The three randomized, double-masked, dose-ranging, placebo-controlled clinical trials comprising the LUMINATE (Luveniq uveitis multicenter investigation of a new approach to treatment) program have enrolled a total of 558 patients at 56 sites in seven countries. Specifically, the LX211-01 trial included 218 patients with active non-infectious uveitis with posterior disease, the LX211-02 trial included 232 patients with clinically quiescent disease and the LX211-03 trial included 108 patients with active uveitis with anterior disease.

Of the three doses studied, the twice daily 0.4 mg/kg dose yielded the most suitable safety profile.

In the LX211-01 study, the twice daily 0.4 mg/kg dose met the primary endpoint of superiority to placebo for average change from baseline in vitreous haze at week 16 and week 24.

In the LX211-02 study, which employed an analysis that accounted for data censoring due to discontinuations unrelated to efficacy, the twice daily 0.4 mg/kg dose statistically significantly reduced the recurrence of inflammation against placebo by 50% at 6 months, which confirmed the positive results from the LX211-01 trial. However, the study did not meet the primary endpoint of all-cause therapeutic failure at 6 months due to discontinuations unrelated to inflammation.

In the LX211-03 study, the efficacy of all dosing groups did not split during the steroid taper; all groups improvement by more than one step average reduction in anterior chamber cells from baseline.

In all three trials, the twice daily 0.4 mg/kg dose had a relatively small effect on renal function; only 1.3% of patients discontinued therapy due to hypertension. Other adverse events included headache, diarrhea and infections, which were similar in incidence to placebo. The drug had no apparent effect on IOP, cataract formation or endothelial cell density, according to the release.

Following a full data analysis, Lux Biosciences plans to submit results of the clinical program for publication, present results at upcoming conferences and prepare submissions for approval. If approved, the drug would be the first corticosteroid-sparing agent to be commercialized for treating uveitis in the United States.