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news.Capstone Therapeutics has completed a limited analysis of a subset of data from its ongoing Phase 2a clinical trial of AZX100, in trocar site scarring following arthroscopic shoulder surgery. Based on this analysis, the clinical trial is expected to continue to its planned 12-month endpoints.
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AZX100 clinical trial is conducted to study the ongoing safety of AZX100. Additionally, Capstone is expected to evaluate the quality of the clinical trial dataset in order to guide future studies and to determine whether continuation of the trial would be futile from a statistical perspective.
Capstone Therapeutics’ ongoing AZX100 Phase 2 clinical trial in trocar site scarring (OL-ASCAR-03) is a double-blind, placebo within-patient controlled, multi-center dose ranging study assessing the safety and preliminary efficacy of AZX100 in trocar sites of subjects who have undergone arthroscopic shoulder surgery.
Randolph Steer, president of Capstone, said: “We have met our objectives for this preliminary analysis of our trocar site scarring trial. Following a limited review of the data by an independent statistician examining AZX100 safety and the quality of the dataset, we have been advised to continue the trial.
“The primary endpoint is the 12-month Patient and Observer Scar Assessment Scale (POSAS) score; secondary endpoints include a series of independently-analyzed, validated, objective measurements of the scar throughout the 12-month post-surgical period.”