Actionable news
0
All posts from Actionable news
Actionable news in MDXG: MiMedx Group, Inc,

MiMedx Files With The FDA To Initiate Its Investigational New Drug Achilles Tendonitis Phase 3 Clinical Trial

MARIETTA, Ga., Aug. 4, 2017 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has filed with the Food and Drug Administration (FDA) to initiate its Investigational New Drug (IND) Phase 3 Achilles Tendonitis clinical study.

The Achilles Tendonitis clinical trial will study MiMedx's AmnioFix® Injectable in a Phase 3, Prospective, Double Blinded, Randomized Controlled Trial of the Micronized dHACM Injection as Compared to Saline Placebo Injection in the Treatment of Achilles Tendonitis. The Company expects patient enrollment to commence in the next few months.

The trial will enroll approximately 158 study patients with moderate to severe pain due to Achilles Tendonitis with failed conservative treatment for at least one month. The IND Phase 3 clinical study objective is to determine the safety and effectiveness of AmnioFix Injectable as compared to the 0.9% Sodium Chloride USP placebo injection control for the treatment of moderate to severe pain due to Achilles tendonitis.

The filed primary efficacy endpoint of this study will be the change in Visual Analog Scale (VAS) score for patients between baseline and Day 90 expressed as the difference in means between the AmnioFix Injectable versus placebo-treated group. The primary safety endpoint will be the incidence of Adverse Events, Serious Adverse Events, and Unanticipated Adverse Events during the first 180 days post injection in the AmnioFix Injectable group versus the placebo-treated group.

The Achilles Tendonitis study will be the second IND Phase 3 trial for MiMedx AmnioFix Injectable. MiMedx plans to submit a Biologic License Application (BLA) to the FDA...


More