China-based Everest Medicines (HKG: 1952) has announced top-line results from a Phase I study in China, demonstrating that EVER206 (also known as SPR206), a novel intravenous polymyxin derivative, is well-tolerated with no evidence of acute kidney injury or new safety signals. The study supports Everest’s plans to initiate next-phase clinical development in China.
Study Results and Pharmacokinetics
The Phase I study in healthy Chinese subjects showed that EVER206 is well-tolerated, with pharmacokinetics comparable to those observed in the overseas Phase I study (SPR206-101). The absence of safety concerns underscores the potential of EVER206 as a safer alternative to existing polymyxin treatments, which are often associated with significant nephrotoxicity and neurotoxicity.
EVER206: Mechanism and Development
EVER206 is a potentially best-in-class polymyxin derivative designed to reduce toxicity, particularly nephrotoxicity, compared to polymyxin B and colistin. These antibiotics are frequently used as a last resort for treating multi-drug resistant (MDR) gram-negative bacterial infections, which pose a significant global health challenge. Under a licensing agreement with Spero, Everest Medicines holds exclusive rights to develop, manufacture, and commercialize EVER206 in Greater China, South Korea, and certain Southeast Asian countries. In July 2021, Spero granted Pfizer Inc. (NYSE: PFE) the rights to develop, manufacture, and commercialize EVER206 (SPR206) in ex-US and ex-Asia territories.
Future Outlook
With positive Phase I results, Everest Medicines is poised to advance EVER206 into the next phase of clinical development. This progress highlights the company’s commitment to addressing unmet needs in the treatment of MDR gram-negative infections, positioning EVER206 as a potential new standard of care.-Fineline Info & Tech
