ASN008 / Asana BioSci, Formation Bio - LARVOL DELTA

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=131 | Completed | Sponsor: TrialSpark | Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=131 | Active, not recruiting | Sponsor: TrialSpark

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: TrialSpark | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: TrialSpark

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

TrialSpark Announces First Patient Dosed in Phase 2 Clinical Trial for ASN008-201 in Atopic Dermatitis (PRNewswire) - "TrialSpark, Inc. announced today that the first patient has been dosed in its Phase 2 clinical trial for ASN008-201...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...Topline data for this trial is expected in 2024."

P2 data • Trial status • Atopic Dermatitis • Dermatology

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. (PubMed, J Pharmacol Exp Ther) - P1 | "We investigated the dose-response, time to onset, and duration of action of ASN008 topical gel, which targets small afferent sodium channels, in a murine model of pruritus in which scratching behavior is induced by intradermal injection of chloroquine into the nape of the neck of C57BL/6 mice. SIGNIFICANCE STATEMENT: ASN008 gel produces a dose-dependent reduction of scratching in a mouse model of pruritus, with a rapid onset and long duration of action, and may prove to be an effective, once or twice-daily treatment for a variety of pruritic conditions in humans, including non-histaminergic itch. ASN008 topical gel is currently under investigation in Phase 1 clinical studies to evaluate safety, tolerability, pharmacokinetics and preliminary anti-pruritic efficacy in atopic dermatitis patients (ClinicalTrials.gov ID: NCT03798561)."

Journal • Preclinical • Anesthesia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Asana BioSciences announces topical sodium channel blocker ASN008 achieves positive results for the treatment of pruritus in atopic dermatitis; and provides update on JAK/SYK inhibitor gusacitinib in phase 2 studies for chronic hand eczema and AD (Businesswire) - P1, N=24; NCT03798561; Sponsor: Asana BioSciences; P2, N=19; NCT03728504; Sponsor: Asana BioSciences; "Dr. Robert Bissonnette, dermatologist, President-Elect of International Eczema Council and President of Innovaderm Research said that 'Patients with CHE suffer greatly from this disease, which limits the ability to work and perform activities of daily living. JAK/SYK inhibitors, such as gusacitinib, have great potential for the treatment of CHE as they can impact several pathways involved in skin inflammation.' As for treatment of itch in clinical practice, Dr. Bissonnette also said that 'There are numerous causes of chronic itch, and our current treatment armamentarium has limited efficacy in most cases. New treatments to control itch are desperately needed.'"

P1 data • P2 data • Atopic Dermatitis • Dermatology • Immunology • Pruritus

Study to Evaluate ASN008 Topical Gel (TG) (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Asana BioSciences; Active, not recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Pruritus

Study to Evaluate ASN008 Topical Gel (TG) (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: Asana BioSciences; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

ASN008, a sodium channel blocker, is well-tolerated after topical administration to healthy normal subjects in a first-in-human (FIH) clinical trial. (EADV 2019) - No abstract available.

Clinical • P1 data

Study to Evaluate ASN008 Topical Gel (TG) (clinicaltrials.gov) - P1; N=32; Recruiting; Sponsor: Asana BioSciences; Active, not recruiting ➔ Recruiting; Trial completion date: Nov 2019 ➔ May 2020; Trial primary completion date: Sep 2019 ➔ Mar 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date

Study to Evaluate ASN008 Topical Gel (TG) (clinicaltrials.gov) - P1; N=32; Active, not recruiting; Sponsor: Asana BioSciences; Not yet recruiting ➔ Active, not recruiting; N=68 ➔ 32

Clinical • Enrollment change • Enrollment closed

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 (AAD 2019) - " Non-histaminergic scratching behavior is induced by intradermal injection of chloroquine (CQ) into the nape of the neck of adult male C57Bl65 mice. Topical application of ASN008 gel produces a dose-dependent reduction of scratching in a mouse model of pruritus, with a rapid onset and long duration of action. These results suggest that topical ASN008 gel may prove to be an effective, once-daily treatment for a variety of pruritic conditions in humans, including non-histaminergic itch."

Preclinical

Study to Evaluate ASN008 Topical Gel (TG) (clinicaltrials.gov) - P1; N=68; Not yet recruiting; Sponsor: Asana BioSciences

Clinical • New P1 trial