Kashiv Biosciences, LLC, a global leader in biopharmaceutical innovation, today announced that their abatacept biosimilar candidate, KSHB002, has successfully met the primary endpoints in its Phase 1 clinical trial. The trial demonstrated pharmacokinetic equivalence to the US-licensed and EU-authorized reference product, ORENCIA®.
KSHB002, a 125 mg/mL pre-filled syringe injection, was evaluated in a randomized, open-label study involving 300 healthy male and female adults. The study was designed with three parallel arms and assessed the pharmacokinetics, safety, and immunogenicity of KSHB002 compared to the reference product. All participants received a single subcutaneous dose.
The results demonstrated that both primary endpoints, maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC₀–∞), were within the 80-125% bioequivalence range, confirming pharmacokinetic equivalence. Furthermore, the safety and immunogenicity profiles of KSHB002 were comparable to those of ORENCIA®.
Kashiv Biosciences is developing the proposed abatacept biosimilar as both subcutaneous and intravenous formulations.
“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. This represents a pivotal step in advancing the evaluation of KSHB002 for patients with rheumatoid arthritis,” stated Dr. Sandeep Athalye, CEO of Kashiv Biosciences.
About Kashiv Biosciences:
Kashiv Biosciences, LLC is a vertically integrated biopharmaceutical company with a diverse portfolio of commercial and advanced clinical-stage assets. Operating in the United States and India, Kashiv Biosciences leverages robust infrastructure and highly skilled teams to deliver global R&D, clinical, manufacturing, regulatory, and IP capabilities. Our mission is to advance patient care and improve access to affordable essential medicines.
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Contacts
Dr. Paras Vasanani
paras.vasanani@kashivbio.com
www.kashivbiosciences.com
