First Patient Dosed in TrialSpark's Phase 2 Trial of ASN008-201 in AD
ASN008 is a permanently charged sodium channel blocker that has been formulated in a polymer-based gel.
The first patient has been dosed in TrialSpark’s Phase 2 clinical trial for ASN008-201, a topical sodium channel blocker in development for pruritus associated with atopic dermatitis (AD).
This clinical trial is a randomized, double-blind, vehicle-controlled, Phase 2 trial to evaluate the anti-pruritic efficacy, safety, tolerability, and pharmacokinetics of ASN008 in adults with mild to moderate AD (NCT05870865).
Topline data for this trial is expected in 2024.
"We are thrilled to have dosed our first patient in this clinical trial," says Gavin Corcoran, Chief Development Officer at TrialSpark, in a news release. "Dermatology is a core focus area for our company, and there is enormous unmet patient need, so we're looking forward to progressing this clinical trial as efficiently as possible."
This clinical trial will enroll approximately 120 participants at around 28 study sites across the United States. Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25%, ASN008 gel 2.5%, ASN008 gel 5%, or matching vehicle twice a day for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period.
"We are grateful to the patients who are participating in this clinical trial and to the healthcare professionals who are working with us to advance our research," adds Benjamine Liu, TrialSpark CEO and Co-Founder. "Our company's mission is to bring new treatments to patients faster than ever before, and the contributions of patients, doctors, and sites are essential to achieving that goal."
In November 2022, TrialSpark announced the formation of Libertas Bio following the acquisition of a majority position in a portfolio of immunodermatology assets from Asana BioSciences. The Libertas Bio pipeline includes ASN008, as well as global rights to gusacitinib, an oral Phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema.
For more information about the clinical trial, please visit https://www.trialspark.com/trial/eczema.