(By Balaseshan) BioMimetic Therapeutics Inc. (NASDAQ: BMTI), which develops products to heal musculoskeletal injuries and diseases, said it has began a phase 2 Augment Chronic Tendinopathy clinical trial to treat tennis elbow.
The company initiated enrollment in a phase 2 clinical trial to assess the safety and efficacy of Augment Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis, commonly known as tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S.
Augment Chronic Tendinopathy (ACT) is being developed to treat chronic tendon injuries, or tendinosis. The target indication for this clinical trial is lateral epicondylitis, commonly referred to as tennis elbow.
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Lateral Epicondylitis is an inflammation of the tendons that join the forearm muscles on the outside of the elbow. The forearm muscles and tendons become damaged from overuse, or in some cases trauma, leading to pain and tenderness on the outside of the elbow.
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.
The trial 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.
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The product candidate is aimed at the large tendinosis market for which there is significant unmet clinical need with limited effective long-term treatments currently available.
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.
BMTI is trading up 2.01% at $7.60 on Thursday. The stock has been trading between $1.87 and $7.85 for the past 52 weeks.