Gusacitinib

NEW YORK, Nov. 29, 2022 /PRNewswire/ -- TrialSpark announced today 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 now includes global rights to gusacitinib, an oral Phase 3-ready dual JAK/SYK inhibitor in development for chronic hand eczema, and ASN008, a Phase 2-ready topical sodium channel blocker in development for pruritus associated with atopic dermatitis. Libertas Bio will continue the development of these assets, leveraging TrialSpark's tech-enabled drug development capabilities to bring these therapies to patients faster and more efficiently. Financial terms of the transaction were not disclosed. After acquiring a portfolio of immunodermatology assets from Asana BioSciences, TrialSpark forms Libertas Bio. Gusacitinib has the potential to be the first oral therapy approved in the US for the treatment of chronic hand eczema (CHE). In a phase 2b study, Gusacitinib 80mg was shown to have a statistically significant and potentially clinically meaningful improvement across both primary and secondary endpoints and was well tolerated. CHE is an underserved condition with high unmet need, impacting up to 10% of adults, with no approved treatments in the US and few available off label options. CHE has a significant negative impact on quality of life, including psychosocial health and workforce productivity, and can lead to a number of comorbidities such as sleep disturbance and depression. ASN008 has shown promising efficacy data in pruritus (itch) associated with atopic dermatitis, and is a Phase 2-ready complementary pipeline program to gusacitinib. Chronic itch is a hallmark of atopic dermatitis, which impacts more than 16.5 million patients in the US. ASN008 has the potential to be used in combination with other topical and systemic therapies in atopic dermatitis, as well as a meaningful opportunity to expand into other itch and pain related indications. "We are excited about the opportunity to add these important products to our portfolio of development assets," said Dr. Gavin Corcoran, TrialSpark's Chief Medical Officer. "Both chronic hand eczema and itch are conditions that negatively affect the lives of the patients that have them, as well as their families. An effective treatment has the potential to improve the quality of life for both." Beyond gusacitinib and ASN008, the transaction also included a preclinical dual JAK/SYK inhibitor named ASN011. Libertas Bio is open to in-licensing additional complementary products to build a differentiated pipeline focused on immunodermatology treatments. Prior to this transaction, TrialSpark has in-licensed multiple assets, deploying capital and pursuing the development of drug programs as part of its mission to bring new treatments to patients faster and more efficiently. As part of its business development strategy, TrialSpark uses balance sheet capital to develop, acquire and/or license assets, leveraging its in-house drug development engine to run trials significantly faster and more efficiently than industry standards. TrialSpark is actively pursuing partnerships with both small biotech and larger pharma companies through flexible and creative collaboration structures, maximizing the potential value of drug candidates for all stakeholders through faster and more efficient clinical development programs. For example, the company recently partnered with global pharmaceutical company Sanofi to jointly acquire and develop novel therapies. TrialSpark is focused on clinical stage assets in rheumatology, dermatology, CNS, and cardiometabolic diseases, with a focus on chronic diseases that are treated outside of a hospital setting. About TrialSpark Founded in 2016, TrialSpark is a tech-driven pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data. The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases. Contacts TrialSpark Business Development: jorge.ramirez@trialspark.com TrialSpark Press Inquiries: lily@trialspark.com

April 22, 2021 14:52 UTC 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. ASN003 is in Phase 1 development for BRAFV600 mutated metastatic melanoma, metastatic colorectal and advanced non-small cell lung cancer, and advanced solid tumors with PI3K pathway alterations (NCT02961283). 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.