MiMedx Group has randomised and enrolled the first patients in a Phase lll clinical trial to evaluate the safety and efficacy of AmnioFix Injectable in patients with recalcitrant plantar fasciitis pain.
The prospective, double-blinded, randomised controlled investigational new drug (IND) trial will enrol roughly 164 patients across 15 centres.
During the trial, patients will be randomised 1:1 in two treatment groups who will receive either a single injection of saline (placebo control) or a single injection of 40mg of AmnioFix Injectable.
The trial's primary efficacy endpoint is the change in visual analogue scale (VAS) score between the baseline and day 90, expressed as the difference in means between the two groups.
The study’s primary safety endpoint is the occurrence of adverse events, serious incidents, and unanticipated ill-effects during the first 180 days post-injection in the AmnioFix Injectable group versus the placebo-controlled group.
MiMedx Group chairman and CEO Parker Petit said: “For a long time, physicians treating musculoskeletal degeneration pain have highlighted the need for a new safe and durable first-line therapy, especially an injectable product.
“We believe AmnioFix Injectable meets this need and will quickly become the physician's product of choice for the vast majority of their patients.”
Top-line results from the new Phase lll trial are expected in the second half of next year.
After completing the trial, MiMedx is set to file a biologic licence application (BLA) with the US Food and Drug Administration for AmnioFix Injectable to treat moderate to severe plantar fasciitis pain by 2020.