First Patient Dosed in Clinical Trial Combatting Pruritus

The first patient has been dosed in a clinical trial evaluating the efficacy of ASN008-201 in the treatment of atopic dermatitis (AD)- related pruritus.

TrialSpark Inc., a technology-driven pharmaceutical company, announced the news via a press release.¹ The double-blind, randomized, and vehicle-controlled phase 2 clinical trial, known as the Soothe Study for Eczema-Related Itch, is exploring the efficacy of a new investigational drug, ASN008-201, a topical sodium channel blocker, in relieving AD-related itch, as well as determining its efficacy, safety, tolerability, and pharmacokinetics.

It is expected to enroll approximately 120 adult participants with mild to moderate AD. Participants are required to have persistent pruritus related to their AD and to have an AD diagnosis for at least 12 months prior to the start of the trial.

The 8-week trial is set to take place across 28 sites within the United States. Following a 28-day screening period, eligible participants will be randomized to receive a dose of ASN008-201 or a vehicle on a twice-daily basis for 28 days. Treatment groups will include ASN008 gel 1.25%, ASN008 gel 2.5%, ASN008 gel 5%, or a vehicle control. Participants have a 75% chance of receiving the investigational drug containing active ingredients.

A 28-day follow-up period will take place after the treatment period.

This is not the first time ASN008 has been investigated in AD and pruritus. In 2020, a study² was published evaluating the efficacy of ASN008 in a mouse model. The phase 1 trial, conducted by Asana BioSciences, resulted in a reduction of scratching behavior.

Topline data for the trial is expected in 2024.

Reference

1. TrialSpark. (2023, May 23). TrialSpark announces first patient dosed in phase 2 clinical trial for ASN008-201 in atopic dermatitis. PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/trialspark-announces-first-patient-dosed-in-phase-2-clinical-trial-for-asn008-201-in-atopic-dermatitis-301832396.html#:~:text=NEW%20YORK%2C%20May%2023%2C%202023,with%20atopic%20dermatitis%20(AD).
2. Ramachandran R, Thompson SK, Malkmus S, Mieda T, Lin JH, Gupta S, Yaksh TL. Topical Application of ASN008, a Permanently Charged Sodium Channel Blocker, Shows Robust Efficacy, a Rapid Onset, and Long Duration of Action in a Mouse Model of Pruritus. J Pharmacol Exp Ther. 2020 Sep;374(3):521-528. doi: 10.1124/jpet.120.265074. Epub 2020 Jul 2.