PhaseBios Phase 1 PB2452 clinical trial results published in the NEJM
Category: #health  By Pankaj Singh  Date: 2019-03-18
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PhaseBios Phase 1 PB2452 clinical trial results published in the NEJM

PhaseBio Biopharmaceuticals Inc., a U.S.-based clinical-stage biopharmaceutical company, has reportedly announced that results of its Phase 1 clinical trial  of PB2452, which is a new reversal agent for the anti-platelet drug ‘ticagrelor’, have been published in the NEJM (New England Journal of Medicine). The results have been published in a specific paper presented by Dr. Deepak Bhatt, Executive Director, Interventional Cardiovascular Programs at Brigham & Women’s Hospital, during a clinical research session at the 68th ACC (Annual Scientific Session) of the American College of Cardiology, New Orleans.

As per authentic sources, the Phase 1 clinical trial – which is a randomized, first-in-human, placebo-controlled and double-blind – evaluated the efficacy, safety and pharmacokinetics of the intravenous, ticagrelor reversal agent PB2452 in health volunteers. Sources added that 64 volunteers aged between 18 to 50 years allegedly received either placebo or PB2452. The results apparently depicted that PB2452 reversed ticagrelor’s anti-platelet effects, with no drug-related adverse events, infusion-related reactions or dose-limiting toxicities reported. The only treatment-emergent adversative event most frequently reported was the infusion site bruising of about 8.3 per cent and there were no further unfavorable events reported resulting in hospitalization or drug discontinuation.

Dr. Bhatt was quoted saying that patients taking the ticagrelor for lessening any cardiac event’s risk, currently have no effective method to reverse the drug’s antiplatelet effects that in turn, enhances the risk of major, spontaneous bleeding.

PB2452, for the uninitiated, is a novel, human monoclonal antibody and antigen-binding fragment that is designed for reversing ticagrelor’s anti-platelet activity in the event of urgent surgeries and major bleeding.

According to John Lee, Ph.D., M.D., Chief Medical Officer, PhaseBio, the company has received quite some motivation with the clinically-meaningful results of the latest trial that highlight PB2452’s potential to provide immediate, sustained reversal of the ticagrelor antiplatelet activity and moreover address essential unmet medical needs. He further stated that the company expects to initiate a similar Phase 2a trial in this year’s first half and to continue evaluating PB2452.



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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