The Phase I trial (NCT05413161) was a randomised, double-blind, comparative pharmacokinetic study evaluating ADL018 compared to EU-approved omalizumab and US-licensed omalizumab. A total of 306 participants were divided into three treatment arms to receive one of the three drugs via subcutaneous injection.
The primary objective of this study was to demonstrate pharmacokinetic similarity by assessing the area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax). Safety and tolerability were also compared between the three groups.
Kashiv’s COO Dr Chandramauli Rawal stated: “For all comparisons of primary endpoints (AUCinf and Cmax), the 90% confidence intervals (CIs) of the geometric least squares means ratio were fully contained within the pre-defined equivalence margin of 0.80-1.25. The IgE levels, safety profiles and immunogenicity were also comparable among the three treatment groups.”
Xolair is approved to treat chronic spontaneous urticaria (CSU) in patients aged 12 years and over who persistently experience hives with H1 antihistamine treatment. It is also approved to treat asthma unresponsive to inhaled corticosteroids and chronic rhinosinusitis with nasal polyps in adults.
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Kashiv has already had two biosimilars approved to market by the US Food and Drug Administration (FDA), namely Releuko (a biosimilar to Amgen’s Neupogen) and Fylnetra (a biosimilar to AbbVie’s Humira). The company said it has a pipeline of seven biosimilars.
Kashiv’s CEO Dr Sandeep Gupta said: “This [study] is a significant step for Kashiv towards achieving its mission of developing high-quality, biosimilar products that are widely accessible and improve patients’ lives.
“We are looking forward to initiating dosing in the global Phase III study soon in chronic spontaneous urticaria (CSU) patients. In parallel, we are actively seeking commercial partners globally to maximise the potential of this drug.”