Late-breaking science bodes improvements

In four Late-breaking Research presentations, researchers presented significant developments for treating plaque psoriasis, Candida nail infections, and prurigo nodulari.

Expanding indications
Data showing that a biologic currently used in psoriatic arthritis may be effective in plaque psoriasis made headlines during the first Late-breaking Clinical Trial session on Saturday.

Early results from the CIMPASI-1 and CIMPASI-2 trials suggest that certolizumab may be effective in treating chronic plaque psoriasis. Certolizumab is approved by the Food and Drug Administration for psoriatic arthritis and other inflammatory diseases, but not for plaque psoriasis.

The trials compared 200 mg and 400 mg of certolizumab every two weeks against placebo in patients with moderate to severe chronic plaque psoriasis. Alice B. Gottlieb, MD, PhD — professor of dermatology at New York Medical College — reported the initial 16-week trial results. Both trials will run for 144 weeks, including an open-label segment.

PASI 75 responder rates were 66.6 percent for the 200 mg dose and 75.8 percent for the 400 mg dose versus 6.5 percent for placebo in CIMPASI-1. CIMPASI-2 had similar results: 81.4 percent for the 200 mg dose and 82.6 percent for 400 mg versus 11.6 percent for placebo.

PGA 0/1 responder rates were 47 and 57.9 percent versus 4.2 percent for placebo in CIMPASI-1; in CIMPASI-2, they were 66.8 percent for 200 mg and 71.6 percent for 400 mg versus 2 percent for placebo.

“There is clinically meaningful and statistically significant improvement with certolizumab,” Dr. Gottlieb said. “And when you ask patients, the results were very, very good from their perspective.”

Positive results for Candida nail infection
Phase II results for a novel fungal CYP51 inhibitor indicate the oral product is safe and effective in eliminating Candida albicans nail infections. The trial compared four formulations of VT-1161 against placebo for 48 weeks. An ongoing follow-up phase will track outcomes to 96 weeks.

“We have a drug that is clinically very effective as well as very safe,” said Amir Tavakol, PhD, chief development officer for Viamet. “None of the patients stopped treatment due to an adverse event.”

The trial compared 300 mg and 600 mg doses over both 12 and 24 weeks. An intent-to-treat analysis showed a complete cure rate up to 42 percent in the treatment arms compared to zero in the placebo arm. Cure rates hit 51 percent among patients who completed the entire course. Phase III trials are planned for later this year.

New topical for plaque psoriasis
Benvitimod, a novel nonsteroidal cream, showed superiority to placebo and calcipotriol ointment in patients with mild to moderate plaque psoriasis. A phase III trial compared 1% Benvitimod to calcipotriol 0.005% and placebo over 12 weeks of treatment and a 48-week open label follow-up phase. At week 12, benvitimod showed 51.2 percent PASI75 compared to 37.9 percent for calcipotriol and 14.5 percent for placebo.

The two active agents showed clear superiority to placebo from week two, said Jian Zhong Zhang, MD, professor and chair of dermatology, People’s University Hospital in Beijing. Benvitimod began to show growing superiority to calcipotriol at week six. Nearly half of patients, 49.2 percent, remained in remission at the end of the follow-up period.

Benvitimod also had the highest rate of adverse events. The most common adverse events were mild, moderate, and transient erythema, as well as stinging and warmth at application sites.

Serlopitant successful against prurigo nodularis
In one of the largest randomized controlled trials to date of serlopitant, the small molecule agent showed good safety and efficacy against prurigo nodularis (PN). The agent blocks the tachykinin neurokinin 1 receptor (NK1-R), an important pathway for the perception of pruritus.

PN is often refractory to first line treatments, such as topical steroids, but second line therapy includes systemic agents with significant safety issues, such as thalidomide and gabapentin, said Sonia Stander, MD, PhD, professor of clinical neurodermatology at the University of Munster in Munster, Germany.

The study compared serlopitant 5 mg daily to placebo over an eight-week treatment period and two weeks of follow-up in 127 patients with refractory NP. Serlopitant was superior for reducing pruritus at two weeks with increasing superiority over the course of the trial.

“The efficacy and safety findings in the TCP-102 study support further investigation of serlopitant for the treatment of pruritus in patients with PN,” Dr. Stander said.

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