The on-going COVID-19 pandemic has negatively impacted the current ecosystem of clinical trials as a whole. New or on-going clinical trials have essentially stopped in most nations across the globe except for COVID-19. However, as on-going lockdown measures are gradually being lifted; companies have started resuming these clinical trials.
As per the latest news, Bone Therapeutics, a bone cell therapy organization that specializes in addressing unmet medical needs in the in orthopedics, has reportedly commenced treating the first patient in JTA-004 phase III clinical trial at Hong Kong SAR after a slight relaxation in lockdown measures was introduced.
According to sources, JTA-004 is the company’s next generation of intra-articular injectable developed for treating osteoarthritic pain in the knee. The JTA-004 phase III clinical trial is a randomized, controlled, and double-blind trial. It will assess the potential of an intra-articular, single injection of JTA-004 to decrease osteoarthritic pain compared to other leading existing osteoarthritis treatment in the market like placebo or Hylan G-F 20.
Reportedly, Bone Therapeutics will conduct this study in around 20 centers in six European nations along with Hong Kong SAR. The company has already granted approval to begin the JTA-004 phase III clinical trial in five of the seven territories. It anticipates getting approval in the other two nations in the next month.
Speaking on which, Miguel Forte, MD, Ph.D., CEO at Bone Therapeutics said that the resumption of the JTA-004 phase III clinical trial with the start of patient recruitment is a crucial development for patients suffering from the underserved and chronic condition of knee osteoarthritic pain and seeking new treatments that could be offered by its enriched protein solution.
Mr. Forte added that the regulatory authorities in five nations are approving this clinical trial reinforces the need for improved alternatives to the present treatments for this extremely prevalent knee condition. The recommencement of phase III clinical trial would support the company undertaking on-going and upcoming business discussions and would also form a sound basis for its interactions with the US FDA (Food and Drug Administration), states Mr. Forte.