Topical Formulation CY-002 Safe and Tolerable in Cutaneous Warts

Lisa Pagan, PhD

New data from a randomized, placebo-controlled, first-in-human trial of CY-002 indicated that the topical formulation was safe and tolerable for daily use in patients with cutaneous warts.

The topical treatment CY-002 is a formulation of a novel 27-amino acid alpha-helical tumor membrane-targeting peptide intended to achieve HPV-oriented, immune-targeted treatment in affected patients.

Typically, treatments for cutaneous warts have focused on the destruction of epithelium as opposed to the targeting of HPV-infected keratinocytes.

With this first-in-human proof-of-concept clinical study, an investigative team led by Lisa Pagan, PhD, Department of Dermatology at Leiden University Medical Center, in The Netherlands, explored the safety, tolerability, and efficacy of topical CY-002 in adults with cutaneous warts.

Eligible patients were 18 years or older who were generally healthy with ≥1, ≥3 mm cutaneous warts on the hand. Prior to being treated with the topical formulation, washout of wart-removing products was required for 30-60 days.

Following the washout, patients made weekly visits for the clinical research unit during at-home treatment of 28 days, and were included in 6- and 12-weeks of follow up.

One droplet of 15–30 mg CY-002 1% or placebo cream was applied once daily, followed by overnight occlusion, and treatment adherence, which included safety and efficacy data, was monitored via a mobile e-diary application.

A total of 55 patients were enrolled in the study, 52 of whom completed treatment and 49 who finished follow-up. In all patients, baseline and disease characteristics were similar, though patients on placebo were more treatment-naïve than those treated with CY-002, at 67.9% and 33.3%, respectively (P=0.009).

Of the 28 planned doses of CY-002, the mean home treatment compliance was 27 doses (96.4%) in both groups. Only 2 patients reported mild application site irritation, and adverse events were similar between groups.

Investigators observed that 2 patients (7.7%) achieved full clearance and 4 (15.4%) had clearance ≥1 of treated lesions following CY-002 treatment, while full clearance was observed in 1 (3.8%) patient and 3 (11.5%) patients had clearance ≥1 of treated lesions following placebo.

A ≥50% lesion volume reduction was recorded in 21 CY-002-treated warts (41%) and 13 lesions (25%) following placebo (P = 0.0962), and HPV viral load decreased within the first week after treatment initiation.

The team attributed the high placebo responses to CY-002 group being comprised of few treatment-naïve patients compared to the placebo group.

“A high placebo response was observed in this study and the difference between CY-002 and placebo did not reach statistical significance,” they wrote. “Considering different drug delivery strategies may aid the development of CY-002 for cutaneous warts.”

The study, "Results of a randomized, placebo-controlled, first-in-human trial of topical CY-002 in patients with cutaneous warts," was published online in JEADV.