chymase

Efficacy and safety of EP262 to be assessed in a randomized, placebo-controlled study in ~90 patients Second of three clinical proof-of-concept studies to be initiated in second half of 2023 SAN DIEGO--(BUSINESS WIRE)-- Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CSU, a Phase 2 clinical proof-of-concept study of EP262 in subjects with chronic spontaneous urticaria (CSU). By blocking activation of MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria (hives) and atopic dermatitis (eczema). EP262 represents a novel, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the side effects observed with other approaches. “Chronic spontaneous urticaria is a debilitating condition driven by activation of mast cells, and there is growing evidence that non-IgE mediated mast cell activation via MRGPRX2 may play an important role in the disease,” said Christian Weyer, M.D., M.A.S, Chief Medical Officer at Escient. “We are excited to initiate Phase 2 clinical development of EP262 for CSU, as it has the potential to become a much needed, once daily oral treatment option that is safe and able to alleviate the spontaneous occurrence of itchy hives via a novel, highly targeted mechanism.” CALM-CSU is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics of EP262 in approximately 90 patients with CSU who are inadequately controlled with H1-antihistamines. Patients will be randomized, in a 1:1:1 ratio, to treatment with EP262 50 mg, EP262 150 mg, or placebo, administered orally, once daily for 6 weeks, followed by an off-treatment follow-up period. The primary efficacy endpoint is the change from baseline in the urticaria activity score over 7 days (UAS7), a validated and widely used measure of disease activity. More information about this study is available on (Identifier: NCT6077773). About EP262 EP262 is a potent, highly selective once-daily small molecule antagonist of MRGPRX2, a receptor expressed on mast cells that is activated by numerous ligands, including many peptides released from sensory neurons as well as other cell types. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Escient’s preclinical data demonstrates that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell-mediated diseases, with an initial focus on chronic urticarias and atopic dermatitis. About Chronic Urticaria Chronic urticaria, defined as urticaria persisting for more than 6 weeks, manifests with very itchy hives that may vary in size and can significantly impact a patient’s quality of life by interfering with sleep and daily activities. Some patients with chronic urticaria may also develop swelling deeper under the skin or in other tissues (angioedema). There are two main forms of chronic urticaria. In chronic spontaneous urticaria (CSU), hives occur spontaneously, without known triggers. In chronic inducible urticaria (CIndU), hives are induced by specific triggers such as cold exposure (cold urticaria) or touch (symptomatic dermographism), among others. About Escient Pharmaceuticals Escient Pharmaceuticals is a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Based in San Diego, California, Escient is led by an experienced management and scientific team and funded by top-tier life science investors. Visit to learn more. View source version on businesswire.com: Contacts Aaron Mishel Chief Financial Officer Escient Pharmaceuticals, Inc. ir@escientpharma.com Source: Escient Pharmaceuticals, Inc. View this news release online at:

Evommune to receive up to $60 million in upfront and milestone payments, and is eligible for tiered royalty payments on future sales of EVO756 in Japan Company provides pipeline update: Based on Phase 2a results of EVO101 in atopic dermatitis, Evommune will no longer pursue this program and will focus its resources on rapidly advancing its broad pipeline of systemically administered product candidates PALO ALTO, Calif., Sept. 27, 2023 /PRNewswire/ -- Evommune, Inc., a biotechnology company discovering and developing new ways to treat immune-mediated inflammatory diseases, today announced that it has entered into a strategic collaboration with Maruho Co., Ltd, to exclusively develop and commercialize EVO756 in Japan. Under the terms of the agreement, Evommune is eligible to receive up to $60 million in upfront and customary milestone payments. In addition, Evommune is eligible to receive meaningful royalties on future sales of EVO756 in Japan. EVO756, Evommune's MRGPRX2 antagonist, is an investigational therapy targeting MRGPRX2 for multiple inflammatory conditions, with the potential to be a first-in-class oral treatment for a variety of mast cell mediated disease, as well as diseases involving sensory neuron mediated cutaneous itch. Evommune is currently completing the final stages of non-clinical development and expects to submit an Investigational New Drug (IND) Application for EVO756 to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023. The Company plans to initiate clinical programs for various diseases in early 2024, subject to clearance by the FDA. "With three out of five people worldwide dying as a result of chronic inflammatory diseases, Evommune is aiming to pioneer new ways to treat, and gain control over, inflammation. We are laser-focused on developing therapies that not only address symptoms but also halt progressive disease, and EVO756 is well on its way," said Luis Peña, President, and Chief Executive Officer. "We are thrilled to enter into this collaboration with Maruho, a globally respected organization that has developed and commercialized pharmaceuticals in Japan for over 100 years. We believe that this is the start of a long term, multifaceted relationship between Evommune and Maruho, with the potential to accelerate development and access to EVO756 for patients in Japan and around the world." Separately, following a review of results from its Phase 2a trial evaluating the safety and efficacy of a small molecule interleukin 1 receptor-associated kinase 4 (IRAK4) inhibitor, EVO101, in adults with mild-to-moderate AD, Evommune has decided to discontinue development of the program in AD and focus its resources on advancing its pipeline of systemically administered product candidates which have multiple milestones expected over the next several years. Mr. Peña continued, "We executed a robust and well-controlled Phase 2a study of EVO101 designed to show significant improvement over standard of care, and this allowed us to make an efficient decision based on the data." About EVO756 EVO756 is a potent, highly selective small molecule antagonist of mas-related G-protein coupled receptor X2 (MRGPRX2). MRGPRX2 is most abundantly found on mast cells and peripheral sensory neurons. MRGPRX2 can trigger IgE-independent activation (degranulation), which can lead to a variety of symptoms depending on the tissue that is affected. This receptor is unique in that it can respond to a wide variety of ligands, including neuropeptides, proteases, cytokines, antimicrobial peptides and others. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Evommune's pre-clinical data demonstrates that by blocking activation of MRGPRX2 and degranulation of mast cells, EVO756 has the potential to be a first-in-class oral treatment for a variety of mast cell mediated diseases. In addition, due to its unique function on peripheral sensory neurons, EVO756 could provide fast relief of itch associated with inflammatory diseases, such as atopic dermatitis, by blocking MRGPRX2. EVO756 represents a new, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the serious side effects observed with other approaches. About Evommune, Inc. Evommune, Inc., a Palo Alto based biotech company, is creating game-changing science to treat immune-mediated inflammatory diseases by discovering, developing, and delivering therapies that address symptoms and halt progressive disease. For more information, please visit Evommune.com. Contact: Paul Laland 415.519.6610 Paul.laland@evommune.com

First of three clinical proof-of-concept studies to be initiated in second half of 2023 Study will evaluate EP262 in ~30 patients with symptomatic dermographism and cold urticaria using an open-label design and objective endpoints SAN DIEGO--(BUSINESS WIRE)-- Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in CALM-CIndU, an open label Phase 1b clinical proof-of-concept study of EP262 in subjects with chronic inducible urticaria (CIndU). By blocking activation of MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell mediated diseases with an initial focus on chronic urticaria (hives) and atopic dermatitis (eczema). EP262 represents a novel, targeted approach to the treatment of these disorders with the potential for once-daily oral administration without the side effects observed with other approaches. “Chronic inducible urticaria is a debilitating condition driven by activation of mast cells in response to common triggers that are exceedingly difficult to avoid in daily life, resulting in an urgent need for novel therapeutic options,” said Dr. Martin Metz, Professor of Dermatology and Allergy at Charité, Universitätsmedizin in Berlin, Germany. “MRGPRX2 antagonism with EP262 is an exciting and promising therapeutic approach in that it targets a novel pathway to specifically block non-IgE-mediated mast cell activation with once-daily oral dosing.” CALM-CIndU is an open-label Phase 1b study designed to evaluate the safety, tolerability and pharmacodynamics of EP262 in approximately 30 patients with either symptomatic dermographism or cold urticaria, the two most common forms of CIndU. Pharmacodynamic assessments include changes from baseline in disease-specific provocation thresholds that are used as objective markers both diagnostically and pharmacodynamically to quantify disease severity and response to treatment. EP262 will be administered orally, once daily, at a 150 mg dose for 4 weeks, followed by an off-treatment follow-up period. More information about this study is available on (Identifier: NCT06050928). “Initiation of the CALM-CIndU study marks another important milestone in our quest to evaluate and harness the therapeutic potential of MRGPRX2 antagonism in a broad range of mast cell-mediated disorders,” said Christian Weyer, M.D., M.A.S, Chief Medical Officer of Escient. “Following the successful completion of our Phase 1 first-in-human study earlier this year, our team is on track to initiate additional clinical proof-of-concept studies in chronic spontaneous urticaria and atopic dermatitis in the coming months.” About EP262 EP262 is a potent, highly selective once-daily small molecule antagonist of MRGPRX2, a receptor expressed on mast cells that is activated by numerous ligands, including many peptides released from sensory neurons as well as other cell types. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Escient’s preclinical data demonstrates that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell-mediated diseases, with an initial focus on chronic urticarias and atopic dermatitis. About Chronic Urticaria Chronic urticaria, defined as urticaria persisting for more than 6 weeks, manifests with very itchy hives that may vary in size and can significantly impact a patient’s quality of life by interfering with sleep and daily activities. Some patients with chronic urticaria may also develop swelling deeper under the skin or in other tissues (angioedema). There are two main forms of chronic urticaria. In chronic spontaneous urticaria (CSU), hives occur spontaneously, without known triggers. In chronic inducible urticaria (CIndU), hives are induced by specific triggers such as cold exposure (cold urticaria) or touch (symptomatic dermographism), among others. About Escient Pharmaceuticals Escient Pharmaceuticals is a clinical-stage company focused on developing novel therapeutics to address a broad range of neurosensory-inflammatory disorders. The company’s pipeline includes two first-in-class small molecule antagonists targeting MRGPRX2 for the treatment of various mast cell mediated disorders and MRGPRX4 for cholestatic pruritus. Based in San Diego, California, Escient is led by an experienced management and scientific team and funded by top-tier life science investors. Visit to learn more. View source version on businesswire.com: Contacts Aaron Mishel Chief Financial Officer Escient Pharmaceuticals, Inc. ir@escientpharma.com Source: Escient Pharmaceuticals View this news release online at: