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Everest Medicines Announces Approval of Investigational New Drug Application by China NMPA for SPR206

Friday, September 24, 2021

Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia, announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the People's Republic of China has approved the investigational new drug (IND) application under Class One category for SPR206 (also known as EVER206), a novel, intravenous next-generation polymyxin product candidate in development for the treatment of multi-drug resistant (MDR) gram-negative bacterial infections.

"The emergence of antibiotic drug resistance and hospital-acquired infection caused by it are a significant global health issue and are also an area of critical and growing concern globally over last decades," said Sunny Xu Zhu, Chief Medical Officer for Infectious Disease at Everest Medicines. "To combat this issue, Everest is developing and locally manufacturing a novel antibiotic to address infections caused by drug-resistant microorganisms. We are pleased with the IND approval of SPR206 as a Class One innovative drug, which underscores the initiation of independent development of SPR206 led by Everest in China and marks an important milestone for this potentially best-in-class innovative polymyxin antibacterial drug. The IND approval allows Everest Medicines to initiate the clinical development of SPR206 in its territory and fulfill the goal of providing new weapons for physicians in the future to address this critical unmet clinical need."

"The manufacture of SPR206 drug substance (DS) and drug product (DP) for the China Phase 1 clinical trial were completed in five months domestically, which demonstrates our commitment to evolve Everest into a fully integrated pharmaceutical company," said Steven Hu, PhD, Chief Technology Officer of Everest Medicines. "We will continue to support the future development of SPR206 through a local manufacturing pathway to accelerate the drug development process."

Spero Therapeutics previously reported data from its first Phase 1 double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial of SPR206 suggesting that SPR206 is well-tolerated, with no evidence of nephrotoxicity at doses within the anticipated therapeutic range for MDR gram-negative bacterial infections. In June 2021, Spero initiated two Phase 1 trials of SPR206, to assess the intrapulmonary pharmacokinetics after intravenous infusion of SPR206 in healthy subjects, as well as the safety and pharmacokinetics in subjects with different renal function after intravenous infusion of SPR206. Data from both clinical trials are expected by early 2022. Everest will start the planned clinical program in China shortly and expect Phase 1 study results in 2022.

About SPR206

SPR206 is a potentially best-in-class, novel polymyxin derivative that was designed to reduce the toxicity, especially nephrotoxicity, compared to that observed clinically with polymyxin B and colistin. Polymyxins are antibiotics frequently used as a last resort for challenging MDR gram-negative infections, but they are associated with significant neurotoxicity and nephrotoxicity. A series of animal studies, in vitro studies and studies in healthy subjects have been completed to-date that demonstrate a favorable safety profile for SPR206 and in-vitro and in-vivo studies indicate the antibacterial activity of SPR206 is similar or superior to polymyxin B or colistin.

Under an earlier licensing agreement with Spero, Everest Medicines has exclusive rights to develop, manufacture and commercialize SPR206 in Greater China, South Korea and certain Southeast Asian countries (the "Territory") for the treatment of MDR gram-negative bacterial infections. Spero has granted Pfizer Inc. (NYSE: PFE) the rights to develop, manufacture, and commercialize SPR206 in ex-U.S. and ex-Asia territories in July 2021.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asia markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations in Asia and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules and vaccine, many of which are in late stage clinical development. The Company's focused areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.

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