Netherlands: The topical formulation of CY-002 was safe and manageable for daily treatment in patients with cutaneous warts, as per new findings from a randomized, placebo-controlled, first-in-human study, published in The Journal of the European Academy of Dermatology and Venereology.

CY-002 is a topical formulation of a new 27-amino acid alpha-helical tumour membrane-targeting peptide designed to deliver HPV-oriented, immune-targeted therapy in afflicted individuals. Treatments for cutaneous warts have traditionally focused on the destruction of epithelium rather than the targeting of HPV-infected keratinocytes. As a result, Lisa Pagan and colleagues carried out this trial to investigate the tolerability, safety, and effectiveness of topical CY-002 in people with cutaneous warts.

Potential participants were 18 years or older, in good health, and had 1, 3 mm cutaneous warts on their hands. A washout of wart-removing agents was necessary for 30-60 days prior to treatment with the topical formulation. Following the washout, participants made weekly visits to the clinical research facility for 28 days of at-home therapy, and were followed up on at 6- and 12-week intervals. Once daily, one droplet of 15–30 mg CY-002 1 percent or placebo cream was applied, followed by overnight occlusion, and treatment adherence, including safety and effectiveness data, was tracked using a mobile e-diary application.
The key findings of this study were as follows:
1. A total of 55 individuals were included in the trial, with 52 completing therapy and 49 completing follow-up.
2. Baseline and illness features were similar in all patients, while patients on placebo were more treatment-naive than those on CY-002, at 67.9% and 33.3%, respectively.
3. In both groups, the mean home treatment compliance was 27 doses (96.4%) of the 28 scheduled CY-002 doses.
4. Only two patients experienced moderate application site discomfort, and adverse events were comparable across groups.
5. Following CY-002 therapy, investigators noticed that 2 patients (7.7%) obtained full clearance and 4 (15.4%) had clearance of 1 of treated lesions, whereas full clearance was seen in 1 (3.8%) patient and 3 (11.5%) patients had clearance of 1 of the treated lesions.
In conclusion, in this trial, there was a substantial placebo response, and the gap between CY-002 and placebo did not approach statistical significance. Thinking about multiple medication delivery techniques might help in the creation of CY-002 for cutaneous warts.
Reference:
Pagan, L., Yfanti, C., Rijneveld, R., Todd, M., Jongste, P., Feijen, J., Klaassen, E., Bouwes Bavinck, J., Struijk, L., de Koning, M., Prestegarden, L., and Rissmann, R. (2022), Results of a randomized, placebo-controlled, first-in-human trial of topical CY-002 in patients with cutaneous warts. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.18291