US-based biotechnology company Cellphire Therapeutics has stopped enrolling subjects in its CRYPTICS trial of CLPH-511 following feedback from an independent data monitoring committee.
The feedback was given on pre-planned interim analysis of safety and efficacy data from more than 150 subjects, indicating positive outcomes.
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The CRYPTICS trial is assessing CLPH-511, an investigational cryopreserved platelet product designed for treating uncontrolled haemorrhage in individuals who are undergoing cardiopulmonary bypass surgery.
It has reportedly achieved its primary efficacy endpoint of 24-hour chest tube drainage, demonstrating CLPH-511’s statistical non-inferiority compared with the standard room temperature control platelet product, with a one-sided significance level lower than p-value 0.00965.
Cellphire described the results as a ‘significant step forward’ in the development of bleeding management solutions, helping the company meet its aim of offering a long-shelf-life platelet alternative to improve access to essential care worldwide.
With the end of subject enrolment, the company anticipates the final trial visits and the collection of data by the second quarter of this year.
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By GlobalDataIt expects to provide further updates as it continues to develop cryopreserved platelet products and other technologies derived from platelets.
Cellphire Therapeutics chief medical officer Dr Damien Bates said: “The outcome of the interim analysis brings us a step closer to having a widely available alternative to conventional platelets for the treatment of acute haemorrhage.
“We are encouraged by the progress of the CRYPTICS study and remain committed to addressing the challenges associated with platelet shortage and wastage.”
The development of CLPH-511 is being supported by the US Army Medical Research and Development Command under Contract W81XWH20C0030.
Based in Maryland, Cellphire develops platelet-derived therapies to address critical needs in acute bleeding during cardiac surgery, traumatic brain injuries, trauma and other clinical scenarios.
In addition to CLPH-511, the company’s portfolio includes CLPH-211, a platelet-derived, freeze-dried haemostatic agent.
