vTv Therapeutics Sees Positive Results From Dose Study for Psoriasis Treatment
By Chris Wack
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
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
vTv Therapeutics shares were up 31% to $2.32 in premarket
Write to Chris Wack at firstname.lastname@example.org
(END) Dow Jones Newswires
September 24, 2021 06:36 ET (10:36 GMT)
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