Vitae heralds success in psoriasis, hoping to dispel safety concerns

Vitae Pharmaceuticals ($VTAE) said its in-development psoriasis treatment proved its worth in a short study, looking to calm concerns about the drug's safety and advance it into a bigger trial.

The drug, VTP-43742, is an oral therapy Vitae believes could eventually disrupt the high-dollar market for injectable treatments like Novartis' ($NVS) Cosentyx, potentially treating psoriasis and a handful of related autoimmune diseases.

In a four-week proof-of-concept trial, the tablet provided what Vitae said was a "clear signal of efficacy" by reducing psoriasis severity compared with placebo, though the difference fell short of statistical significance. Vitae argues that psoriasis therapies don't generally show their full strength until around week 12, and the company believes VTP-43742's performance over the course of a month demonstrates its potential in a longer trial.

Vitae is now planning to start a 16-week study in the second half of this year.

Perhaps most important to the biotech's investors, however, are the trial's safety results. Vitae said its oral treatment led to no serious side effects and was well tolerated at both 350 mg and 700 mg per day. Four patients in the high-dose group saw enzyme elevations that often point to liver damage, but each case was reversible, according to the company. No drug-related cardiac abnormalities were observed in the trial, Vitae said.

The concern over VTP-43742's safety stems from Vitae's surprise announcement earlier this month that it enrolled just 34 psoriatic patients in the trial instead of a previously planned 60. The move led many, including Stifel analyst Thomas Shrader, to conclude that Vitae had run into a toxicity issue, sending the biotech's shares down more than 40%.

And that proved to be true. Vitae told analysts on a conference call Wednesday that it had initially planned to test a third, larger dose of VTP-43742 but decided against it in light of the enzyme elevations it saw in the 700-mg group.

The latest top-line data sent Vitae's shares up more than 40% in after-hours trading on Wednesday, helping the company make up some ground but falling short of canceling out its losses earlier this month.

Vitae's pitch with VTP-43742 is that the drug could undercut a new class of autoimmune treatments that rely on injected antibodies to tamp down inflammation. Cosentyx, approved last year,  has posted stellar efficacy in clearing up psoriasis and psoriatic arthritis by blocking the activity of an inflammatory protein called interleukin-17. Vitae's oral candidate targets an upstream protein called RORγt to interrupt the secretion of IL-17 in the first place, and the company believes it has a chance to hit the market with an easier-to-use alternative.

"While the autoimmune market is currently dominated by injectable antibody therapy, we believe VTP-43742 has the potential to expand utilization of oral therapy in a variety of autoimmune disorders, such as psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease with an effective, safe and well tolerated, once-a-day agent," Vitae CEO Jeff Hatfield said in a statement.

- read the announcement