Citius Pharmaceuticals Inc (NASDAQ: CTXR) will continue with its Mino-Lok phase 3 clinical trials following the recommendation by IDMC (Independent Data Monitoring Committee).
IDMC did not find any safety issues. Therefore, it has not suggested any modifications to the power or the sample size to meet the primary objective.
Recommends continuing Phase 3 Pivotal Superiority Trial
Citius CEO, Myron Holubiak, is pleased with the IDMC’s thoughtful guidance and analysis after reviewing the interim study results. He said it received IDMC recommendation as expected to continue Phase 3 Pivotal Superiority study without any modifications.
It is the third recommendation by IDMC. The company faces hurdles in satisfying the safety and efficacy after each review. However, IDMC did not suggest any modifications for the sample size in its third recommendation.
Myron said the company would achieve the primary endpoint with a favorable recommendation from the IDMC.
Citius is expediting efforts to continue Phase 3 clinical trial to cure patients with catheter-related infections. Myron stated it is the most extensive clinical study ever conducted by the company to salvage catheters.
The clinical trial outcome is essential in deciding antibiotic locks to treat people suffering from catheter-related infections. Citius is working on a path to critically ill patients with an effective and safe treatment option to address the complications. In addition, it eliminates the high costs associated with replacing the infected catheters.
The company will expedite its efforts to conclude the trial with the easing of COVID-19 restrictions. In addition, it will discuss with the US FDA and seeks its direction for a favorable outcome.
IDMC will assess the safety of treatment besides protecting participants’ interests. Therefore, each IDMC recommendation is based on the strict parameters outlined in the charter.
The phase 3 clinical study is an open-label, randomized, multi-center, and blinded trial to assess the safety and efficacy of Mino-Lok.
Mino-Lok is an antibiotic lock treatment combining edetate disodium with minocycline. The main objective of this clinical trial is to determine the time between the failure of a catheter and TOC.
Identifies 144 subjects
The company identified that 144 patients meet the criteria to conduct a randomized clinical trial in a 1:1 ratio to receive either standard of care antibiotic lock therapy or Mino-Lok therapy. Therefore, it will administer one MLT dose daily for the subjects in the Mino-Lok trial.