Augment for Tennis Elbow: BioMimetic Commences Enrollment

BioMimetic Therapeutics, Inc. has announced it has initiated enrollment in a Phase II clinical trial to assess the safety and efficacy of Augment Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis, aka tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S. and will evaluate the safety and therapeutic potential of escalating doses of a one-time injection of pure recombinant human platelet-derived growth factor (rhPDGF-BB) homodimer solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow.

“We have seen promising pre-clinical data with ACT and believe the initiation of this Phase II dose finding clinical trial is the logical next step in the development of our sports medicine program, ” said Dr. Samuel Lynch, BioMimetic president and CEO, in the January 3, 2013 press release. “ACT has the potential to help millions of patients suffering from painful inflammation of the tendon at the outer border of the elbow resulting from overuse of lower arm muscles or trauma.”

The primary efficacy endpoints will be derived from a combination of pain and disability assessments as measured by the Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder and Hand (DASH) Score and the Patient Rated Tennis Elbow Evaluation (PRTEE), along with sincerity of effort measured by grip strength testing. These clinical outcome measures will be used to detect changes in pain and function up to 24 weeks from baseline. Adverse event reporting, including incidence, relationship with treatment and severity will be recorded throughout the study to evaluate safety of the drug. The product candidate will be reviewed by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

Kearstin Patterson, senior director of Corporate Communications, told OTW, “We hope the large unmet clinical need for long-term treatment of tennis elbow will translate into swift enrollment of 100 patients. Additionally, we hope to receive positive feedback from the surgeons involved in the trial, many of whom are key opinion leaders in the space and recognize the potential value of a biologic to treat this painful condition of the ECRB tendon, which makes many daily activities a challenge for millions of patients.”