Kashiv BioSciences, LLC today announced the completion of patient enrollment for its Phase III clinical trial of ADL018, a biosimilar candidate to XOLAIR®. This pivotal study aims to compare the efficacy, safety, tolerability, and immunogenicity of ADL018 with XOLAIR® in patients with chronic idiopathic/spontaneous urticaria (CSU) who remain symptomatic despite taking H₁ antagonists. This clinical trial enrolled total 600 patients across multiple sites globally (NCT05774639). The Phase 1 PK/PD study in healthy volunteers was successfully concluded in June 2023 (NCT05413161).

“We are delighted to announce the completion of patient enrollment for our global Phase III trial of ADL018, our most advanced biosimilar candidate following the FDA approval of Releuko® and Fylnetra® in 2022. This milestone underscores our commitment to advancing our biosimilar pipeline and providing cost-effective therapeutic options,” said Dr. Sandeep Gupta, Chief Executive Officer of Kashiv.

“The completion of enrollment for our Phase III trial of ADL018 is a significant achievement for Kashiv, highlighting exceptional capabilities of our team. We are focused on the successful completion of this study and are excited about the potential impact of ADL018 on patients suffering with CSU and other chronic conditions for which omalizumab is approved,” said Dr. Chandramauli Rawal, Chief Operating Officer of Kashiv.

About ADL018

ADL018, a humanized monoclonal antibody designed to inhibit the binding of IgE to FcεR on the surface of mast cells and basophils, is being developed as a biosimilar to XOLAIR® (omalizumab), an injectable prescription medicine approved to treat CSU in individuals aged 12 and older who continue to have hives uncontrolled by H1 antagonists. Omalizumab is also approved for treating moderate to severe persistent asthma in individuals aged 6 and older whose asthma symptoms are not well controlled with inhaled corticosteroids, chronic rhinosinusitis with nasal polyps in individuals aged 18 and older, and IgE-mediated food allergy in adult and pediatric patients aged 1 year and older.

ADL018 matches the pharmaceutical presentations, dosage strength, route of administration, and dosing regimen of the U.S. and EU-approved omalizumab. According to IQVIA, worldwide sales of XOLAIR® in the twelve months preceding March 2024 were approximately $4.5 billion.

About Kashiv BioSciences, LLC

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with comprehensive capabilities in global R&D, clinical development, regulatory affairs, and manufacturing of biosimilars and other complex products. The Company has a robust pipeline of more than eight biosimilars, alongside multiple 505(b)(2) and complex peptide generic products in development. Kashiv is headquartered in Piscataway, NJ with R&D and GMP manufacturing facilities in Piscataway, FDA-approved GMP manufacturing facilities in Chicago, IL, and state-of-the-art R&D infrastructure in Ahmedabad, India. Kashiv is establishing a robust network of strategic commercial partnerships, enhancing our global reach, and harnessing local expertise across key markets including US, Europe, Australia, Latin America and Canada.

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