Kashiv Biosciences has announced positive results from its Phase I clinical trial of KSHB002, an abatacept biosimilar candidate. The trial met its primary endpoints, demonstrating pharmacokinetic equivalence to the reference product, Orencia. This development marks a significant step forward in the evaluation of KSHB002 for treating rheumatoid arthritis.
The randomized, open-label study enrolled 300 healthy adult male and female subjects, divided into three parallel arms. The study assessed the safety, immunogenicity, and pharmacokinetics of a 125 mg/mL pre-filled syringe injection of KSHB002 compared to Orencia, with all subjects receiving a single subcutaneous dose.
Bioequivalence Confirmed
The trial results indicated that the primary endpoints, maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC0–∞), fell within the bioequivalence range of 80%-125%. This confirms that KSHB002 achieves similar drug levels in the body as Orencia.
Safety and Immunogenicity
In addition to pharmacokinetic equivalence, the study found that the safety and immunogenicity profiles of KSHB002 were comparable to those of Orencia. This is a crucial factor for biosimilars, as it indicates that KSHB002 is not expected to elicit a different or more pronounced immune response than the reference product.
Future Development
Kashiv Biosciences is currently developing both subcutaneous and intravenous formulations of KSHB002. The company is planning to advance KSHB002 into a global Phase III efficacy and safety trial.
"We are thrilled with the results of our Phase 1 study and are excited to move forward with our global Phase 3 efficacy and safety trial," said Dr. Sandeep Athalye, CEO of Kashiv Biosciences. "This represents a pivotal step in advancing the evaluation of KSHB002 for patients with rheumatoid arthritis."
About Abatacept and Rheumatoid Arthritis
Abatacept is a costimulation modulator used to treat rheumatoid arthritis, a chronic autoimmune disease affecting approximately 1% of the world's population. Current treatments aim to reduce inflammation and slow disease progression. A biosimilar version of abatacept could offer a more affordable treatment option for patients.
