VBL Therapeutics to discontinue development of compound for psoriasis, ulcerative colitis

VBL Therapeutics announced that it plans to discontinue development of its experimental Lecinoxoid compound, VB-201, since phase 2 studies evaluating its treatment in patients with psoriasis and ulcerative colitis did not meet primary endpoints.

“We are disappointed by the outcome of these phase 2 studies in psoriasis and ulcerative colitis,” Dror Harats, MD, CEO of VBL Therapeutics, said in a company press release. “Immune-inflammatory conditions are difficult-to-treat diseases with a limited array of effective treatments.”

One hundred and ninety-four patients with moderate-to-severe plaque psoriasis were evaluated in a randomized, double-blind study of the safety and efficacy of VB-201 at 80-mg or 160-mg daily dosage for 24 weeks. Psoriasis Area Severity Index (PASI) 50, or the proportion of patients who achieved at least 50% improvement from baseline PASI score, at weeks 16 and 24 was the study’s primary efficacy endpoint. Among the patients studied, VB-201 had no effect compared with placebo for primary and secondary endpoints at either dose level tested, according to the release.

In a separate study evaluating 112 patients with mild-to-moderate ulcerative colitis, VB-201 was dosed at 160 mg daily for 24 weeks, with a primary endpoint of disease remission at 12 and 24 weeks. Again, VB-201 had no statistically significant effect compared with placebo on the study’s primary or secondary endpoints.

In both studies, VB-201 was safe and well-tolerated, with no drug-related serious adverse events, according to the release.

Reference: www.vblrx.com.