The Cuban biotechnology drug Jusvinza is progressing through a Phase III clinical trial for rheumatoid arthritis treatment, marking a significant milestone for the innovative therapeutic developed by the Center for Genetic Engineering and Biotechnology (CIGB). The trial, expected to complete soon, will determine the drug's definitive approval for treating this debilitating autoimmune condition.
Dr. María del Carmen Domínguez Horta, who has led the research project at CIGB for nearly four decades, confirmed that the main study site is the Rheumatology Service of the 10 de Octubre Clinical and Surgical Hospital in Havana. The placebo-controlled, double-blind trial includes patients with moderate rheumatoid arthritis referred by rheumatology specialists from western provinces, with Dr. Dinorah Prada serving as the lead clinical investigator.
Strong Safety Profile Demonstrated
Initial results from the Phase III trial show that Jusvinza maintains a good safety profile, with only mild and reversible adverse events reported. This builds on earlier evidence from the Mariana study, conducted in five eastern provinces and Camagüey following the drug's conditional medical registration in September 2023.
The Mariana study, led by Dr. Osvaldo Calisté Manzano, involved 534 patients with moderate and severe rheumatoid arthritis. According to Dr. Domínguez Horta, "The effects observed consisted of a significant improvement of the clinical picture, while the excellent safety of the drug was ratified."
Expanding Clinical Applications
Dr. Gillian Martínez Donato, the project manager, revealed that clinical studies are being extended beyond rheumatoid arthritis to explore Jusvinza's potential in other autoimmune diseases. The research team is currently focused on demonstrating the drug's effects in ankylosing spondylitis, systemic lupus erythematosus, and inflammatory bowel diseases, with plans to initiate clinical phases for these conditions.
"We also have evidence in real-world studies of patients with a severe state of rheumatoid arthritis, who have had benefits with Jusvinza treatment," Martínez Donato noted. The drug is designed as a therapeutic rather than preventive treatment, targeting patients who already have autoimmune diseases with the goal of achieving remission.
Respiratory Disease Applications
Building on experience gained during the COVID-19 pandemic, where Jusvinza demonstrated effectiveness in controlling hyperinflammation in severe and critical patients, researchers have initiated clinical trials for respiratory conditions. Phase II-III clinical studies are underway for acute respiratory distress syndrome of various etiologies, including trauma and bacterial or viral diseases, as well as severe community-acquired pneumonia.
During the pandemic, Jusvinza received emergency use authorization for critical, severe, and moderate COVID-19 patients, successfully preventing progression to more severe disease stages.
Addressing Significant Medical Need
Rheumatoid arthritis affects approximately 135,000 people in Cuba and represents a substantial global health burden. According to World Health Organization data cited in the research, around 18 million people worldwide had the disease in 2019, with approximately 70% being women and 55% over age 55.
The chronic, autoimmune, systemic disease typically appears between ages 40 and 60, most commonly affecting joints in the hands, wrists, feet, ankles, knees, shoulders, and elbows. Without timely treatment, advanced-stage rheumatoid arthritis can severely damage joint structures and surrounding tissues, significantly impacting patients' ability to perform daily tasks.
Future Prospects
Dr. Domínguez Horta emphasized that Jusvinza's availability positions Cuba to benefit tens of thousands of patients in the near future. Once definitive registration is obtained and sufficient quantities are produced, patients will be able to live with this chronic disease without abandoning work and while maintaining full quality of life.
The research team continues to investigate Jusvinza's mechanism of action and pharmacological properties, recognizing the drug's potential broad spectrum for treating acute and chronic inflammatory diseases. Results have been published in high-impact scientific journals, highlighting the prestige achieved by Cuban biotechnology in this therapeutic area.
With the Phase III trial nearing completion, definitive registration for massive use in Cuba is expected next year, potentially providing a new treatment option for thousands of patients suffering from rheumatoid arthritis and other autoimmune conditions.
