Cuban scientists are advancing a Phase III clinical trial of Jusvinza, a synthetic peptide with immunomodulatory and anti-inflammatory properties, for the treatment of rheumatoid arthritis patients. The expansive study now covers a larger number of patients throughout the country, including the eastern region of Cuba.
The drug achieved a significant regulatory milestone in September when it received sanitary registration from the Cuban regulatory authority for rheumatoid arthritis treatment. According to the State Center for the Control of Medicines and Medical Devices, Jusvinza demonstrated quality, safety, and efficacy in the proposed indication after a rigorous evaluation process.
Clinical Trial Progress and Patient Outcomes
Dr. Raúl Cepero Morales, a specialist in Rheumatology, reported that patients included in the trial have experienced improved quality of life due to the drug's immunomodulatory and anti-inflammatory effects, even before completing the full treatment course. The specialist emphasized that better results are expected in the long term.
The trial has demonstrated a favorable safety profile, with no adverse effects registered in the first four doses administered to patients. This safety record has eliminated the need to suspend administration of the therapy in any cases during the initial treatment phase.
Trial Design and Enrollment
Camagüey province has achieved the highest enrollment with 212 volunteers participating in the Phase III study. The treatment protocol involves an initial series of four doses administered over the first month, followed by monthly doses for six months. Patients who received their first doses have now completed the fourth dose, marking the completion of the first month of treatment.
The current Phase III trial represents an expansion of earlier research that began before the COVID-19 pandemic. The study's scope has been broadened to include more patients across different regions of Cuba, providing a more comprehensive evaluation of the drug's effectiveness in diverse patient populations.
Drug Development Background
Jusvinza was developed by the Center for Genetic Engineering and Biotechnology as a synthetic peptide. During the COVID-19 pandemic, the drug received Emergency Use Authorization for treating severe and critical COVID-19 patients, based on its mechanism of action and pharmacological properties.
The transition from emergency use during the pandemic to formal registration for rheumatoid arthritis treatment represents a significant advancement in the drug's clinical development pathway. The regulatory approval was granted after comprehensive evaluation of clinical evidence supporting its use in rheumatoid arthritis patients.
