Amneal Pharmaceuticals announces results from trial evaluating ADL-018

Amneal Pharmaceuticals (AMRX) highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR, developed by Kashiv BioSciences. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR in patients with Chronic Idiopathic Urticaria, CIU, or Chronic Spontaneous Urticaria, CSU, who remained symptomatic despite treatment with H1 antihistamines. Omalizumab, a humanized monoclonal antibody that targets free IgE, is indicated for the treatment of severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. It is typically administered in a hospital or clinic setting. The clinical study achieved its primary and secondary endpoints by establishing equivalence of therapeutic endpoints and comparable safety between ADL-018 and XOLAIR. Participants received subcutaneous doses of either 150 mg or 300 mg every four weeks for a 24-week period. The primary efficacy measure was the change from baseline in the weekly itch severity score at Week 12 between the treatment arms of ADL-018 and the reference product.