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Alloksys fails to stop kidney injury in heart surgery patients, but subgroup spurs phase 3 plans

2023-08-24

临床2期临床3期

Alloksys Life Sciences plans to start a 400-patient phase 3 clinical trial in the third quarter.

Alloksys Life Sciences’ enzyme-based drug candidate has failed to reduce the rate of acute kidney injury in patients undergoing cardiac surgery. But, while the phase 2b missed its primary endpoint, the Dutch biotech seized on an efficacy signal in a subgroup to make the case for moving into phase 3 immediately.

Alloksys Life Sciencesdomized 271 patients undergoing cardiothoracic surgery to receiacute kidney injuryandidate based on the enzyme alkaline phosphatase, or placebo. Subjects received a bolus of the drug candidate or placebo before surgery, followed by a 24-hour infusion. Because the enzyme has anti-inflammatory effects, Alloksys thinks it may prevent organ damage related to critical care.

Alloksys’ phase 2b failed to show the candidate prevents acute kidney injury in the overRESCAPpulation, causing the study to miss itsalkaline phosphataseet, the biotech buried that key finding and focused on the results in a subgroup of patients who had a normal renal filtration rate at baseline.Alloksys

Alloksysubgroup, “RESCAP exhibited a 70% reduced probabilacute kidney injury

Based on the findings, Alloksys plans to start a 400-patient phase 3 clinical trial in the third quarter. The biotech is tweaking the administration of RESCAP in an attempt to extend the subgroup efficacy signal to patients who have abnormal renal filtration rates at baseline.

“We anticipate that by Alloksysg the administration of RESCAP in the planned phase 3 follow-up trial, it will also prove to be effective for patients with more severe chronic kidney disease before surgery. We firmly believe that the RESCAP intervention has the potential to really impact critical care practices during and after major surgeries,” CEO Ruud Brands said in a statement.

Alloksys plans to file for approval on the strength of RESCAPase 3 data, preferably with a strategic partner. The drug candidate is derived from calf intestines, and tchronic kidney disease supply that can be scaled up.

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