Hamlet BioPharma has announced positive results from its Phase II clinical trial evaluating anakinra, an Interleukin-1 (IL-1) receptor antagonist, as an immunotherapy for recurrent acute cystitis. The study, conducted in collaboration with the University of Giessen, compared anakinra to traditional antibiotic treatment and found similar clinical outcomes, suggesting a potential new approach to managing this common infection while reducing reliance on antibiotics.
Immunotherapy as an Alternative to Antibiotics
The Phase II study was a randomized trial that assigned patients with recurrent acute cystitis to either anakinra or antibiotic treatment. The primary endpoint was the clinical outcome, measured by symptom reduction, recurrence rate, and quality of life. The results indicated that both treatments led to significant improvements in these measures, with no statistically significant difference between the two groups.
"The results illustrate the strong potential of IL-1RA treatment for this important disease," said Florian Wagenlehner, Professor of Urology, University of Giessen.
Addressing Antibiotic Resistance
Urinary tract infections, particularly acute cystitis, affect approximately 50% of women during their lifetime, with many experiencing recurrent infections. The increasing prevalence of antibiotic-resistant strains poses a significant challenge. The World Health Organization recognizes antibiotic resistance as a major threat to global health, emphasizing the urgent need for novel treatment strategies.
Hamlet BioPharma's research explores the possibility of treating bacterial infections by enhancing the body's natural antibacterial defenses through immunotherapy. This approach could potentially decrease the demand for antibiotics in this patient population and, consequently, mitigate the risk of antibiotic resistance.
The Role of IL-1 in Cystitis
The study's focus on anakinra, an IL-1 receptor antagonist, is based on the understanding that IL-1 plays a crucial role in the inflammatory response associated with acute cystitis. By modulating the immune response and reducing inflammation, anakinra aims to alleviate symptoms and prevent recurrence without directly targeting the bacteria.
"The clinical results confirm our extensive molecular studies, identifying IL-1 and IL-1RA as essential regulators of acute cystitis," said Ines Ambite, PhD, Project manager at Hamlet BioPharma.
Future Directions
Hamlet BioPharma plans to submit a more comprehensive analysis of the study results for publication. This will provide further insights into the mechanisms of action and the potential benefits of immunotherapy in managing recurrent acute cystitis. The company has a portfolio of 15 drug projects.
