Therapy Areas: Vaccines
National Institutes of Health Launches its ACTIV-5 "Big Effect Trial" Evaluating Humanigen's Lenzilumab as Potential COVID-19 Therapy
13 October 2020 - - The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, launched its ACTIV-5 "Big Effect Trial" (ACTIV-5/BET), 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, US-based clinical stage biopharmaceutical company Humanigen, Inc., (NASDAQ: HGEN) said.

ACTIV-5/BET, which will enroll at as many as 40 US sites, will evaluate lenzilumab with remdesivir, compared to placebo and remdesivir, in hospitalized COVID-19 patients with approximately 100 patients assigned to each study arm. Humanigen is providing lenzilumab for the study, which is fully funded by NIH.

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.

ACTIV is public-private partnership that has evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized the most promising candidates, designed and harmonized five adaptive master protocols for ACTIV clinical trials, and selected numerous NIH-supported networks to launch these clinical trials to test prioritized therapeutic candidates.

Master protocols allow coordinated and efficient evaluation of multiple investigational agents as they become available, but within the same clinical trial structure, across multiple study sites.

Adaptive protocols swiftly weed out experimental drugs that do not demonstrate effectiveness and identify those that do.

Adaptive master protocols reduce administrative burden and cost, provide a flexible framework to rapidly identify drugs that work, and rapidly move additional experimental agents into the trial.

In addition to lenzilumab from Humanigen, compounds currently included in the ACTIV protocols include remdesivir from Gilead (NASDAQ: GILD), LY-CoV555 from Eli Lilly (NYSE: LLY), Apixaban from Bristol Myers Squibb Co. (NYSE: BMY) and Eli Lilly and company, and Risankizumab from Boehringer Ingelheim/AbbVie Inc (NYSE: ABBV).

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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