Published On: Apr 22, 2021
Last Updated On: Jul 8, 2021
April 22, 2021 10:52 AM Eastern Daylight Time
LAWRENCEVILLE, N.J.–(BUSINESS WIRE)–Asana BioSciences, a clinical stage biopharmaceutical company, announced that it will present additional positive results from a Phase 2b study evaluating the efficacy and safety of its investigational oral Janus kinase family (JAK) and spleen tyrosine kinase (SYK) inhibitor gusacitinib (ASN002) in adult patients with moderate-to-severe chronic hand eczema (CHE) in a late-breaking research program at the American Academy of Dermatology Virtual Meeting (AAD VMX 2021), to be held April 23 – 25, 2021.
The details of the presentation are as follows:
Study Title: Efficacy, Patient Reported Outcomes and Safety of Gusacitinib (ASN002) in Chronic Hand Eczema: Results of a Phase 2b, Randomized, Double-blind, Placebo-Controlled Study.
Presenter: Howard Sofen, M.D., Associate Clinical Professor of Medicine/Dermatology and Pediatrics, University of California, Los Angeles, and Chief of Dermatology at LA County/Olive View Medical Center United States
Session: Late Breaking Abstracts
Date/Time: 24th April 2021 /2:00 – 3:00 PM US EDT
Chronic hand eczema is often debilitating and affects approximately 10% of the U.S. population and millions of people worldwide. The Phase 2b study was a randomized, double-blind, placebo-controlled, parallel-group study evaluating oral gusacitinib (40 mg or 80 mg once daily) in moderate to severe CHE patients for up to 32 weeks, with the primary endpoint of mean modified total lesion severity score (mTLSS) at week 16 (NCT03728504). The physician global assessment (PGA) and pruritus were among the key secondary endpoints studied.
Howard Sofen, MD, the presenting and one of the lead investigators said, “The results of this trial are very impressive and provide evidence that gusacitinib may be an effective once-daily, oral treatment option for CHE patients who are unable to achieve adequate control with topical corticosteroids and other unapproved treatments. Gusacitinib showed a significant effect on mTLSS, PGA, pain, and pruritus at week 16. Rapid improvements in primary and secondary endpoints were observed during the first 2 weeks of treatment, and effects were sustained over the 32-week study. In addition, gusacitinib was effective in patients with chronic foot eczema and atopic dermatitis (as measured by vIGA in CHE patients who also had AD involvement) in this study. The most common treatment-emergent adverse events were upper respiratory tract infection, headache, nausea, and nasopharyngitis. No pulmonary embolism, opportunistic infections, malignancies, major adverse cardiovascular events, or deaths were reported in the study,” Dr. Sofen said.
About Asana BioSciences, LLC
Asana BioSciences is a clinical stage biopharmaceutical company based in Lawrenceville, NJ. Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.
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ASN004 is an antibody drug conjugate that targets the 5T4 oncofetal antigen, which is expressed in a wide range of malignant tumors but has very limited expression in normal tissues. ASN004 demonstrates robust and durable antitumor activity after single administration in multiple human tumor xenograft models. A First-in-Human Phase 1 trial is planned for the first half of 2021.
ASN008 is a novel, topical Na+-channel blocker with high functional selectivity for itch and pain sensing neurons without affecting motor neurons. In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief after a single application, which lasted between 8-12 hours, and no tachyphylaxis to this response was observed after 2 weeks of daily application (NCT03798561). ASN008 also has potential for the treatment of pain, urologic and other chronic conditions.
ASN009 is a selective antagonist of the purinergic P2X3 ion channel that is activated by extracellular ATP and involved in various pain, urological and respiratory disease conditions. Preclinical proof-of-concept has been demonstrated with ASN009 in a cough model. ASN009 is currently in preclinical development.
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