Kashiv BioSciences Concludes Patient Enrollment for Phase III Study of ADL018, a Biosimilar to XOLAIR® (omalizumab)
Friday, July 26, 2024
Kashiv BioSciences, LLC has completed patient enrollment for its Phase III clinical trial of ADL018, a biosimilar candidate to XOLAIR®. This pivotal trial is designed to assess how ADL018 compares to XOLAIR® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria (CSU) who have persistent symptoms despite H1 antagonist treatment. The study has enrolled 600 participants across various global sites (NCT05774639). Additionally, the Phase 1 pharmacokinetics/pharmacodynamics study in healthy volunteers was successfully concluded in June 2023 (NCT05413161).
Kashiv, expressed, “We are pleased to announce that we have completed patient enrollment for our global Phase III trial of ADL018. This achievement underscores our commitment to advancing our biosimilar pipeline and offering cost-effective therapeutic solutions.”
Kashiv, remarked, “Reaching this milestone for our Phase III trial of ADL018 is a major accomplishment, reflecting the strength of our team. We are dedicated to completing this study successfully and are excited about the potential of ADL018 to benefit patients with CSU and other chronic conditions treated with omalizumab.”
ADL018 is a humanized monoclonal antibody aimed at blocking IgE from binding to FcεR on mast cells and basophils. It is being developed as a biosimilar to XOLAIR® (omalizumab), which is an injectable medication used for treating CSU in individuals aged 12 and older who remain symptomatic despite H1 antagonists. Omalizumab is also indicated for moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies. ADL018 will align with the pharmaceutical forms, dosage strength, route of administration, and dosing schedule of omalizumab as approved in the U.S. and EU. According to IQVIA, XOLAIR® had global sales of approximately $4.5 billion in the twelve months preceding March 2024.
Source: businesswire.com
