Gusacitinib

NEW YORK, May 23, 2023 /PRNewswire/ -- TrialSpark, Inc. announced today that the first patient has been dosed in its 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. Atopic dermatitis is a chronic inflammatory skin disease, and pruritus is the most burdensome and prevalent symptom in patients suffering from AD. Treating atopic itch, which impacts more than 16.5 million patients in the US, has historically been a challenge due to an incomplete understanding of the multiple mechanisms underlying its pathogenesis. "We are thrilled to have dosed our first patient in this clinical trial," said Gavin Corcoran, Chief Development Officer at TrialSpark. "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," said 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." For more information about the clinical trial, please visit . 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, and cardiometabolic diseases. TrialSpark is actively growing its development pipeline. In November 2022, the company 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. TrialSpark also announced the formation of Highline Bio following the acquisition of worldwide rights to sprifermin - a potential first-in-class disease modifying treatment for osteoarthritis - from Merck KGaA, Darmstadt, Germany. Media Contact: [email protected] BD/Partnerships Contact: [email protected] SOURCE TrialSpark

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