Evommune Announces Strategic Collaboration with Maruho to Develop and Commercialize MRGPRX2 antagonist EVO756 in Japan

2023-09-27

临床2期引进/卖出临床申请

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 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