PhaseBio reveals Phase 2a study results for PB2452 in older patients
Category: #health  By Paroma Bhattacharya  Date: 2019-06-19
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PhaseBio reveals Phase 2a study results for PB2452 in older patients

The new data is consistent with the formally published Phase 1 trial data of younger subjects treated with ticagrelor alone

PhaseBio Pharmaceutical Inc., a clinical stage biopharmaceutical company that focuses on developing and commercializing novel therapies for orphan diseases, recently announced the positive preliminary data for PB2452 from the Phase 2a clinical trial, which is its first trial that includes both older (ages 50-64) and elderly (ages 65-80) patients on dual antiplatelet therapy of low-dose aspirin and ticagrelor.

Apparently, the trial subjects resemble the patient population who are more likely to be treated with ticagrelor and if approved, probably benefit from PB2452. The trial witnessed statistically important reversal of ticagrelor 5 minutes within the initiation of PB2452 infusion and it sustained for more than 20 hours. Within 15 minutes of PB2452 infusion, platelet function was normalized, and it remained so for more than 20 hours.

Reportedly, PB2452 has seemingly tolerated the Phase 2a trial well till date, with only minor adverse events being reported. PhaseBio’s formerly published Phase 1 trials showed results similar to these new data, the trial of which was conducted in healthy younger volunteers who were treated with no aspirin but ticagrelor alone. 

There were three assays in the Phase 1 trial to measure its efficacy and the same were used to measure the efficacy of PB2452 during Phase 2a trial, with results demonstrating high correlation from all three assays in both the trials.

John Lee, M.D., Ph.D., PhaseBio’s Chief Medical Officer, said that at present, it is recommended the patients who take antiplatelet therapies like ticagrelor stop their regimen for minimum 5 days before the supposed surgery to avoid the risk of major bleeding. This is not an option for patients who require an emergency or urgent surgery.

There are no methods to reverse the antiplatelet agents’ effects for patients who are experiencing major bleeding. The approval of PB2452 could address the unmet medical needs by having the safety profile of ticagrelor enhanced. It has the potential to become the sole antiplatelet therapy with a specific reversal agent to be on the market, Lee added.

 

Source Credit- https://investors.phasebio.com/news-releases/news-release-details/phasebio-announces-positive-preliminary-results-phase-2a



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Paroma Bhattacharya

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Paroma Bhattacharya

Paroma currently works as a content developer for Algosonline, MSF and a series of alike platforms. Fortified with a post-graduation degree in Journalism and Mass Communication, she delved head long into a writing career, creating resourceful and information enriched ...

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