October 27, 2020 -- Nektar Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application for its interleukin-2 (IL-2) pathway agent NKTR-214 (Bempegaldesleukin) for evaluation in a phase IB clinical study in adult patients with mild COVID-19 infection.
Enrollment in the randomized, double-blind, placebo-controlled study is expected to begin in early November. The trial will enroll up to three cohorts of 10 patients each, who will receive increasing doses of the drug with the goal of evaluating safety and tolerability and to identify a recommended dose for future studies. The study will be conducted at various sites in the U.S.
Bempegaldesleukin is an investigational cluster of differentiation 122 (CD122)-preferential IL-2 pathway agonists that stimulates the immune system through proliferation of lymphocytes. It is currently being evaluated in six separate late-stage clinical trials for patients with melanoma, renal cell carcinoma, and bladder cancer.
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