US-based biopharmaceutical company Kashiv Biosciences has reported that a Phase I trial of its 125mg/mL pre-filled syringe injection, KSHB002, has achieved its primary endpoints.
In the trial, the abatacept biosimilar candidate KSHB002 showed pharmacokinetic equivalence to the reference product, Orencia.
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The randomised, open-label study enrolled 300 healthy adult male and female subjects and was divided into three parallel arms.
It aimed to evaluate the injection’s safety, immunogenicity and pharmacokinetics against Orencia, with all subjects receiving a subcutaneous dose.
According to the trial findings, the primary endpoints, maximum serum concentration (Cmax) and area under the concentration-time curve from time zero to infinity (AUC₀–∞) all fell within the bioequivalence range of 80%-125%.
In addition, the biosimilar’s safety and immunogenicity profiles were comparable to those of the reference product.
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By GlobalDataKashiv Biosciences is currently developing subcutaneous and intravenous formulations of the injection.
Kashiv Biosciences CEO Dr Sandeep Athalye said: “We are thrilled with the results of our Phase I study and are excited to move forward with our global Phase III efficacy and safety trial.
“This represents a pivotal step in advancing the evaluation of KSHB002 for patients with rheumatoid arthritis.”
Kashiv Biosciences provides global research and development, manufacturing, clinical, regulatory and intellectual property capabilities to advance patient care and expand access to affordable essential medicines.
Based in New Jersey, the company operates in India and the US, with a focus on delivering a portfolio of commercial and clinical-stage assets.
In July 2024, Kashiv Biosciences finished enrolling subjects in a Phase III study of ADL018, a biosimilar to Xolair.
The study enrolled 600 subjects worldwide and aims to assess the biosimilar’s efficacy in chronic idiopathic/spontaneous urticaria treatment in subjects who are symptomatic despite H1 antagonist treatment.
In the same month, the company entered an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialisation of ADL018 in the US.
