Vitae starts Phase I multiple ascending dose trial of VTP-43742 to treat autoimmune disorders

These autoimmune disorders include psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications.

The company intends to conduct this multiple ascending dose clinical trial in two populations.

In the trial’s first part, the safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple ascending doses of VTP-43742 will be evaluated in healthy human volunteers.

The trial’s second, proof-of-concept portion will see the company evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical efficacy profile of multiple ascending doses of VTP-43742 in psoriatic patients, with top-line clinical efficacy results from those patients expected by the end of this year.

The trial coincides with an ongoing Phase I single ascending dose study of VTP-43742, which the company started in June and for which results are expected in the second half of this year.

Vitae chief scientific officer Dr Richard Gregg said: "The initiation of this second Phase I study of Vitae’s ROR?t inhibitor marks significant progress for this exciting first-in-class product candidate.

"Our team looks forward to examining whether VTP-43742 can provide a safe and effective oral treatment option for a broad range of patients with serious autoimmune conditions."

In preclinical trials, VTP-43742 has showed potent inhibition of IL-17 secretion from Th17 cells, was highly selective versus other ROR isotypes, and has a predicted human oral dosing schedule of once-a-day.