Biopharmaceutical firm MiMedx Group has obtained approval from the US Food and Drug Administration (FDA) for the initiation of its investigational new drug (IND) Phase IIb clinical trial of AmnioFix Injectable in patients with osteoarthritis of the knee.
AmnioFix Injectable is a micronised dehydrated human amnion chorion membrane altered minimally for the protection of collagen matrix and its natural properties.
Being developed to decrease formation of scar tissue and improve healing, the investigational candidate is processed through the firm’s Purion Process, which combines cleaning, dehydration, and sterilisation.
The prospective, double-blinded, randomised Phase IIb trial will compare the safety and effectiveness of the injectable to saline (0.9% sodium chloride) placebo.
With plans to commence enrolment in the next quarter, the trial will include around 318 subjects.
MiMedx Group CEO Parker Petit said: "This knee osteoarthritis study is the fourth IND trial conducted by MiMedx for our AmnioFix Injectable.
"We are pleased to receive the FDA's notification that we can proceed with another IND study in the Orthopedic/Sports Medicine area.
"We are excited about our progress in moving our focus into the biopharmaceutical market, and we look forward to keeping our shareholders apprised on our future study results."
The trial’s primary efficacy endpoints are changes in the Visual Analogue Scale (VAS) score and Western Ontario and McMaster Universities (WOMAC) osteoarthritis index between baseline and day 90.
During the 12 months after injection, the trial will evaluate primary safety endpoint as the proportion of AmnioFix-related adverse events, serious adverse events, and unanticipated adverse events.