Item 7.01. Regulation FD Disclosure.
OnApril 4, 2022 ,PhaseBio Pharmaceuticals, Inc. (the "Company") issued a press release entitled "PhaseBio Announces Positive Results from Phase 2b Trial for Bentracimab." The full text of the press release (the "Press Release") is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.
Item 8.01. Other Events.
On
The Phase 2b clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, which enrolled a total of 205 older volunteers (50-80 years old), with 154 subjects receiving bentracimab and 51 subjects receiving placebo, after all were pretreated with dual antiplatelet therapy composed of ticagrelor and low-dose aspirin. The primary efficacy endpoint for the Phase 2b clinical trial was reversal of ticagrelor's inhibition of platelet function in actively treated subjects versus placebo as measured using the point-of-care VerifyNow® PRUTest® platelet function assay (VerifyNow). In the Phase 2b clinical trial, bentracimab significantly restored platelet function within five minutes of administration (p<0.001), as measured by multiple assays including VerifyNow. The reversal results were tightly correlated across all assays used in the study to measure platelet function. There were no drug-related serious adverse events or thrombotic events reported in the Phase 2b clinical trial. Overall, bentracimab appeared well tolerated, with subjects reporting only non-serious adverse events. The most-commonly reported adverse events were injection site bruising and headache, with similar rates seen in both the placebo and active-treatment arms. There was no significant difference between bentracimab and placebo for any of the adverse events reported.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description 99.1 Press Release, datedApril 4, 2022 , entitled
"PhaseBio Announces Positive
Results from Phase 2b Trial for Bentracimab". 104 Cover page interactive data file (formatted as Inline XBRL).
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