Humanigen Inc (fka HGENQ)

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NIH/NIAID Locks ACTIV-5/BET-B Database

https://ir.humanigen.com/English/news/news-details/2022/NIHNIAID-Locks-ACTIV-5BET-B-Database/default.aspx

SHORT HILLS, N.J.--(BUSINESS WIRE)-- Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a late-stage clinical biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, confirms that notice was received today from the National Institute of Allergy and Infectious Diseases (NIAID) that they have completed database lock for the Big Effect Trial of lenzilumab (BET-B) being conducted as part of the National Institutes of Health (NIH) public-private partnership Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV). NIH/NIAID has cleaned and locked the blinded data in the study. This significant milestone allows NIH/NIAID to complete topline analysis. Humanigen expects to receive topline results from NIH/NIAID in July.

“Locking the database marks a crucial step in the process of NIH/NIAID completing the evaluation of lenzilumab for patients hospitalized with COVID-19 and reporting the results of its study. We look forward to being able to share topline results once received from NIH/NIAID,” said Cameron Durrant, Chairman and Chief Executive Officer, Humanigen.

Lenzilumab is an investigational product and is not approved or authorized in any country.

About ACTIV-5/BET-B

The Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) is a National Institutes of Health (NIH) directed public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. ACTIV is led by a working group of senior scientists representing government, industry, non-profit, philanthropic, and academic organizations and is pursuing five fast-track focus areas most ripe for opportunity, one of which is accelerating clinical testing of the most promising vaccines and treatments. Within this focus area ACTIV-5 (Big Effect Trial, BET) is a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints to evaluate whether certain therapies, approved or investigational, show promise treating patients hospitalized with COVID-19.

Within ACTIV-5, lenzilumab is the first and only anti-human GM-CSF treatment to be tested in ACTIV as a concomitant therapy with remdesivir compared with placebo plus remdesivir. Lenzilumab was selected from among 400 compounds that were considered for investigation in ACTIV. The study began in October 2020 and was comprised of hospitalized patients who need medical care for COVID-19 pneumonia and randomized (1:1) to the treatment groups. Patients receive a loading dose of 200-mg intravenous (IV) remdesivir on day 1 followed by a 100-mg once-daily IV maintenance dose up to a 10-day total course while hospitalized. Lenzilumab (or placebo) is administered at 600-mg IV lenzilumab infusion every 8 hours starting on Day 1 for a total of three doses. Patients hospitalized with COVID-19 and requiring oxygen supplementation were recruited from 63 sites across the U.S. and two sites in South Korea. The pre-specified primary analysis population consists of patients in the intent to treat (ITT) population with a CRP<150 mg/L and age<85 years not requiring mechanical ventilation or ECMO at baseline. The primary endpoint is the proportion of patients, in the primary analysis population, that died or required mechanical ventilation or ECMO through day 29.