Everest Medicines Announces Partner Providence Reports Positive Top-Line Data from Phase 2 Primary Immunization Trial for mRNA COVID-19 Vaccine Candidate in Adults – PR Newswire

by | Oct 19, 2022 | COVID-19

— Levels of neutralizing antibodies generated by PTX-COVID19-B were non-inferior to Comirnaty®—- PTX-COVID19-B was well tolerated with no safety signals—- Everest is filing IND applications for phase 3 clinical trials for booster indication–
SHANGHAI, Oct. 19, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest”, or the “Company”), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that its partner Providence Therapeutics Holdings Inc. (“Providence”) reported positive top-line data from a Phase 2 study evaluating the safety, tolerability and immunogenicity of its mRNA COVID-19 vaccine candidate, PTX-COVID19-B. Everest licensed the rights to PTX-COVID19-B for Greater China, Southeast Asia and Pakistan, from Providence in 2021 as part of a broad partnership to develop mRNA products globally leveraging the technology platform.
PTX-COVID19-B demonstrated non-inferiority compared to Comirnaty®, Pfizer’s and BioNTech’s U.S. FDA-approved mRNA vaccine, with respect to the geometric mean titer (GMT) ratio of neutralizing antibodies observed two weeks after the second of two intramuscular injections. Additionally, PTX-COVID19-B was generally well-tolerated, with a safety and tolerability profile similar to Comirnaty®.
The Phase 2 study recruited 565 participants aged 18 to 64 years at multiple sites in Canada and South Africa. PTX-COVID19-B was administered to 374 study participants and was generally well tolerated, with a tolerability profile similar to Comirnaty®. The overall incidence of all-cause solicited adverse events (AEs) was similar between both treatment groups after the first and second doses: 71.6% and 59.0% for PTX-COVID19-B and 74.2% and 62.4% for Comirnaty®, respectively. Solicited local AEs after the first and second doses were 62.6% and 53.8% for PTX-COVID19-B and 65.1 …

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