Bone Therapeutics treated the first patients in a pivotal JTA-004 Phase III clinical study in Hong Kong. Tweny other clinical trial sites in Europe are expected to resume recruitment activities as COVID-19 lockdown measures are gradually lifted.
The controlled, randomized, double-blind trial will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic knee pain vs. placebo or Hylan G-F 20 (Synvisc, Sanofi Genzyme). The company expects to enroll over 675 patients with mild to moderate symptomatic knee osteoarthritis.
JTA-004 is a formulation of intra-articular injectables comprising a mix of plasma proteins, hyaluronic acid and a fast-acting analgesic to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phase II study involving 164 patients, JTA-004 showed an improved pain relief at three and six months vs. Hylan G-F 20.
“The resumption of the JTA-004 phase III study with the start of patient recruitment is a very important development for patients suffering from the chronic and underserved condition of knee osteoarthritic pain and seeking novel treatments that could be provided by our enriched protein solution,” said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. “The regulatory authorities in five countries approving this trial reinforces the need for better alternatives to the existing treatments for this highly prevalent knee condition. The resumption of the phase III study would support Bone Therapeutics undertaking ongoing and future business discussions, and will also form a sound basis for our interactions with the US Food and Drug Agency.”