CorMedix Inc. (NYSE: CRMD) shares rose Wednesday, after the company disclosed positive results of its Neutrolin(R) Phase 3 LOCK-IT-100 study based on recommendation by the independent Data Safety Monitoring Board.
The company, based in Berkeley Heights, New Jersey, is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease.
It reported that, because the pre-specified level of statistical significance was reached and efficacy had been demonstrated, the DSMB recommended the study be terminated early. No safety concerns were reported by the DSMB based on the interim analysis.
The release also said the company will submit the results of the interim analysis to the U.S. Food and Drug Administration for its review.
According to CEO Khoso Baluch, "We are thrilled to have received the DSMB's recommendation that efficacy has been demonstrated. Once we have submitted the interim analysis results and DSMB's recommendation to the FDA, we will begin the dialogue on the appropriate next steps.”
The primary endpoint of the Phase 3 LOCK-IT-100 study is reducing the risk of occurrence of CRBSI by Neutrolin relative to the active control of heparin. The secondary endpoints are catheter patency, which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction, and catheter removal for any reason.
Shares in CorMedix hurtled higher by 10 cents, or 34.3%, to 38 cents in late morning Wednesday trading.
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