MiMedx Group has enrolled the first patient in its Phase IIb clinical trial evaluating the safety and efficacy of AmnioFix Injectable as a treatment for pain associated with Osteoarthritis (OA) of the knee.
The investigational new drug (IND) trial is a double blinded, randomised controlled study that will enrol around 318 patients at 20 centres.
In the trial, patients will be randomised 1:1 in two treatment groups including a single injection of saline (placebo control) or a single 40mg dose of AmnioFix Injectable.
The trial’s co-primary efficacy objects are the change in visual analog scale (VAS) score and the change in Western Ontario and McMaster Universities (WOMAC) osteoarthritis index between baseline and day 90 expressed as the difference in means between each group.
Its primary safety objective is the incidence of adverse, serious adverse, and unanticipated adverse events during the first 12 months post-injection in the AmnioFix Injectable group versus the placebo-controlled group.
MiMedx Group president and COO Bill Taylor said: “Given the lack of treatment options for patients with knee OA, and the high risks associated with using opioids to manage pain, AmnioFix Injectable has the opportunity to address a significant unmet clinical need by providing physicians and their patients with a new, safe, effective and durable front-line therapy for treating OA knee pain.
“In addition, we believe AmnioFix Injectable has the potential to become a blockbuster therapeutic biologic, with long-term peak revenue potentially reaching $4bn for musculoskeletal pain management within the more than $12bn US joint pain injection market.”
OA of the knee is a degenerative and irreversible condition, which is related to pain, restricted mobility, and ultimately leads to joint instability.