vTv Therapeutics Inc. said it saw positive results from a multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 inhibitor for the treatment of psoriasis, in healthy adults.
The biopharmaceutical company said the trial enrolled 12 subjects in each of two dose cohorts, 15mg and 20mg, randomized to receive HPP737 or placebo orally once daily for 14 days.
Dose escalation up to 20mg/day demonstrated approximate dose proportional increases in exposure, while maintaining a favorable safety and tolerability profile with no dose limiting safety or tolerability findings observed. There were no serious adverse events and no discontinuations due to treatment emergent adverse events.
vTv said it believes that the current safety profile allows it to move forward in development with a drug that may achieve anti-inflammatory and anti-psoriatic responses without the significant safety issues of other PDE4 inhibitors.
With these results, vTv held a successful pre-IND meeting with the U.S. Food and Drug Administration Division of Dermatology and Dentistry. As a key outcome of the meeting, the company obtained acknowledgement that the completed studies appear reasonable to support the proposed dosing regimen of 20mg/day for 12 weeks.
The company also received feedback on the proposed safety monitoring and clinical trial endpoints. vTv plans to file an IND application later this year for a 12-week Phase 2 clinical trial evaluating the safety and efficacy of HPP737 in patients with moderate to severe psoriasis with study initiation targeted for early 2022.
