Vitae announce RORyt Inhibitor VTP-43742 phase 1 results

[Fred]

Here's a potential treatment for psoriasis, psoriatic arthritis, and other autoimmune disorders. VTP-43742 is Vitae's first-in-class, wholly owned product candidate for the potential treatment of a variety of autoimmune disorders and orphan diseases.

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Vitae Pharmaceuticals, a clinical-stage biotechnology company, today announced positive top-line results from its Phase 1 single ascending dose clinical study of VTP-43742 in autoimmune disorders. VTP-43742 is Vitae's first-in-class, wholly owned RORγt inhibitor being developed for the treatment of a range of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis and irritable bowel disease (IBD), as well as numerous orphan diseases.

In this double-blind, randomized, placebo-controlled study that evaluated the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profile of single oral doses of VTP-43742 in 53 healthy human volunteers, VTP-43742 was safe and generally well tolerated at all dose levels across a 60-fold dose range. No serious adverse events were reported and there were no drug-related clinical laboratory or electrocardiogram (ECG) abnormalities.

VTP-43742 was also evaluated in an ex vivo assay for its ability to inhibit the production of pro-inflammatory cytokine IL-17A in blood obtained from study subjects. Subjects receiving VTP-43742 showed a dose-dependent suppression of RORγt dependent IL-17A production by more than 90 percent, with the effect largely sustained over the full 24-hour measurement period.

In animal studies, steady inhibition of RORγt was necessary to achieve full therapeutic efficacy, indicating the importance of a relatively long plasma half-life. The plasma half-life of VTP-43742 was observed to be approximately 30 hours in this clinical trial, supporting the potential for effective once-a-day dosing in humans.

"VTP-43742's robust and sustained lowering of IL-17A production observed in the ex vivo blood assay, paired with its favorable safety, tolerability and PK profile, demonstrate that this first-in-class drug candidate has the potential to safely and effectively treat a range of autoimmune conditions," said Dr. Richard Gregg, Chief Scientific Officer of Vitae. "We are extremely encouraged by the PK and PD data, and look forward to reporting additional clinical results, including top-line proof-of-concept data in psoriasis patients, by the end of the year."

Vitae is currently conducting a Phase 1 multiple ascending dose clinical trial of VTP-43742, which was initiated in August 2015. This trial includes both healthy human volunteers and patients with moderate to severe psoriasis. The Company plans to begin dosing psoriatic patients in the second half of 2015, with top-line clinical efficacy results expected by the end of 2015.

Source: vitaepharma.com

[AmandaL]

Don't know if I trust them. It's inflammatory bowel disease not irritable

[Fred]

Don't know if I trust them.  It's inflammatory bowel disease not irritable  

Good observation Amanda, I can see your point.

Tut Tut Vitae Pharmaceuticals, you should spend a little time checking what you say.  

*That'll make the Brandwatch Bot get a little excited.