Therapy Areas: AIDS & HIV
First Patient Dosed in NIH ACTIV-5/Big Effect Trial Evaluating Lenzilumab for COVID-19
29 October 2020 - - The first patient has been dosed at the Emory University School of Medicine in Atlanta, Georgia as part of the in the ACTIV-5 "Big Effect Trial" (ACTIV-5/BET) evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19, US-based clinical stage biopharmaceutical company Humanigen, Inc., (NASDAQ: HGEN) said.

Lenzilumab is Humanigen's lead product candidate and proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to optimize antibody properties.

ACTIV-5/BET, which is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, is designed to determine whether certain approved therapies or investigational drugs in late-stage clinical development show promise against COVID-19 and, therefore, merit advancement into larger clinical trials.

The adaptive, randomized, double-blind placebo-controlled trial evaluating lenzilumab with remdesivir will include up to 200 patients across as many as 40 treatment centers in the US.

There will be approximately 100 patients assigned to each study arm.

ACTIV-5/BET is being conducted in collaboration with the NIH's public-private partnership Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV) program.

The ACTIV partnership has evaluated approximately 400 therapeutic agents with a potential application for COVID-19 and developed a collaborative framework for prioritizing the most promising candidates, streamlining clinical trials, coordinating regulatory processes, and leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.

To date, ACTIV has designed five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.

The primary purpose of ACTIV-5/BET, a randomized, double-blind, placebo-controlled trial, is to evaluate the clinical efficacy of the different investigational therapeutics relative to the control arm in hospitalized adults based on the patients' clinical status at day 8.

The study's secondary point of evaluation is to evaluate the clinical efficacy of the different investigational therapeutics as assessed by the amount of time it takes for each patient to recover from COVID-19.


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