After reviewing available data, Bayer decided to abandon its Phase II development of eliapixant as the benefit-risk profile was not worthwhile.
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Bayer announced that it was abandoning Phase II development of eliapixant, which was being developed for four indications: endometriosis, refractory chronic cough, overactive bladder and diabetic neuropathic pain. The company reviewed available data and decided the benefit-risk profile was not worthwhile.
Eliapixant is a P2X3 receptor antagonist. It came out of a strategic partnership with Evotec SE. The companies continue to collaborate on other projects. ATP-dependent P2X3 receptors play a significant role in the sensitization of nerves and pain pathways. It is also believed that excessive P2X3 receptor activation is involved in neurogenic inflammation.
On January 24, 2022, Merck announced that the U.S. Food and Drug Administration (FDA) had sent them a Complete Response Letter (CRL) for their New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough. Like eliapixant, gefapixant is a P2X3 receptor antagonist. Although Merck did not describe details of the CRL, they did say it was not related to the drug’s safety. The drug was approved in Japan under the brand name Lyfnua.
Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, stated, “We remain committed to advancing gefapixant for patients with refractory or unexplained chronic cough and will work with the FDA to address the agency’s feedback. We believe there is a significant unmet need to help patients manage their chronic cough, as there are no available treatment options indicated in the U.S. specifically for this condition.”
The statements by Bayer and Evotech indicated that Evotec would regain all the rights to all P2X3 assets, and Evotec would continue to analyze the data as soon as it was available to determine the next steps. The company stated, “This decision has no impact on the overall strategic goals as outlined in Action Plan 2025.”
Evotec began calling its strategic frameworks Action Plans in 2009, starting with Action Plan 2012. The latest is called “Action Plan 2025 — The data-driven R&D Autobahn to Cure.” The company said, in describing it, that “we are not just dealing with today’s challenges, but also look ahead to anticipate how the industry is going to evolve. We want to understand what actions we need to take in order to maintain and even further expand our leadership position.”
The Action Plan 2025 is made up of eight “building blocks to improve innovation and accelerate Evotec.” They include integrated data-driven R&D; industrialized high-throughput multi-omics platform (EvopanOmics); advanced data analysis and prediction platform; EVOcells, from cells to therapies; EVOgenes, from genes to therapies; EVOaccess, Just — Evotech Biologics & J.POD — Biologics for all; EVOequity, BRIDGEs & operational venturing; and EVOroyalty, co-own and share products.
The company noted, “These building blocks perfectly fit our strategy to increase innovation and accelerate growth of Evotec as we progress towards 2025. All elements get usage of best possible human databases and modern artificial intelligence instruments to accelerate the drug discovery & development projects.”
BELLUS Health is developing BLU-5937, a P2X3 receptor antagonist, for the treatment of refractory chronic cough. On December 13, 2021, the company announced statistical significance on the primary endpoint of the Phase IIb SOOTHE trial for refractory chronic cough.
And Shionogi is developing sivopixant, a P2X3 receptor agonist for refractory/unexplained chronic cough and neuropathic pain.
