Kashiv Biosciences Announces Positive Phase 1 Study Outcomes for ADL018, a Biosimilar Candidate for Xolair® (Omalizumab)
Wednesday, July 05, 2023
Kashiv Biosciences, LLC ("Kashiv" or the "Company") has announced the successful completion of a Phase 1 clinical study for ADL018, a biosimilar candidate to Xolair® (omalizumab), in healthy volunteers.
Dr. Sandeep Gupta, CEO of Kashiv, expressed satisfaction with the positive Phase 1 results for ADL018, stating that it represents a significant milestone for the company in its mission to develop high-quality biosimilar products that are accessible and improve the lives of patients. Kashiv plans to initiate a Phase 3 study for chronic spontaneous urticaria (CSU) patients soon and is actively seeking global commercial partners to maximize the drug's potential. According to IQVIA®, Xolair® generated approximately $4.0 billion in worldwide sales and $2.8 billion in U.S. sales for the 12-month period ending December 2022.
The Phase 1 study was a randomized, double-blind, comparative pharmacokinetic (PK) study where subjects received ADL018, EU-approved omalizumab, or US-licensed omalizumab via subcutaneous injection. The primary objective was to demonstrate PK similarity by evaluating the area under the concentration-time curve from time zero to infinity (AUCinf) and maximum serum concentration (Cmax), as well as assessing safety and tolerability. Secondary objectives included investigating the pharmacodynamic (PD) activity (total and free IgE levels) and immunogenicity among the three treatment groups.
Dr. Chandramauli Rawal, COO of Kashiv, emphasized that all comparisons of the primary endpoints (AUCinf and Cmax) yielded 90% confidence intervals (CIs) of the geometric least squares means ratio that fell within the pre-defined equivalence margin of 0.80-1.25. Additionally, IgE levels, safety profiles, and immunogenicity were comparable across the three treatment groups. Dr. Rawal highlighted that the successful completion of this study further demonstrates Kashiv's R&D team's excellent capabilities in developing biosimilar and complex products.
ADL018 is a monoclonal antibody designed to inhibit the binding of IgE to the high-affinity IgE receptor (FcεRI) on mast cells and basophils. It is being developed as a biosimilar candidate to XOLAIR® (omalizumab), an injectable prescription medicine approved for the treatment of chronic spontaneous urticaria (CSU) in individuals aged 12 and older who have uncontrolled hives despite H1 antihistamine treatment. Xolair® is also approved for the treatment of moderate to severe persistent asthma in individuals aged 6 and older whose asthma symptoms are not well controlled with inhaled corticosteroids, as well as chronic rhinosinusitis with nasal polyps in individuals aged 18 and older.
ADL018 has the same pharmaceutical form, dosage strength, route of administration, and dosing regimen as the United States and European Union (EU)-approved omalizumab.
