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Emergency Use Authorization requested for leronlimab

August 15, 2020 by Janice Reichert

On August 12, 2020, Cytodyn requested that the Food and Drug Administration grant an Emergency Use Authorization for leronlimab for mild to moderate COVID-19 based on data from the Phase 2 CD10 study (NCT04343651). In this study, patients were randomized to receive weekly doses of 700 mg leronlimab or placebo, both of which were administered via subcutaneous injection. Top-level results of the study showed that, in patients with Total Clinical Symptom Scores of ≥ 4 at baseline (higher scores equate to poorer health state), at Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group (90% on leronlimab arm vs. 71% on placebo). The EUA request was disclosed in an investment community conference call that will be available until September 12, 2020.

  • Leronlimab is a humanized IgG4 antibody targeting C-C chemokine receptor type 5.

Filed Under: COVID-19 Tagged With: antibody therapeutics, clinical, COVID-19, Emergency Use Authorization, Food and Drug Administration, leronlimab

‘Antibodies to watch in 2016’ now free

February 8, 2016 by Janice Reichert

The current late-stage clinical pipeline includes over 50 antibody therapeutics that are listed in the latest installment of the ‘Antibodies to watch’ article series. ‘Antibodies to watch in 2016’ is now freely available on the mAbs website.

Find the article here

mAbs is a journal of the Society, and a special subscription rate of US $63 is available for Society members. To receive the special rate, contact the publisher Taylor & Francis at 1 (800) 354-1420 (Fax: (215) 207-0046) or customerservice@taylorandfrancis.com

Filed Under: Ab news, Phase 3 pipeline Tagged With: antibodies, clinical, pipeline

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