Pharmaceutical & Life Sciences News

NIH’s Experimental Ebola Medicine Clears Initial Safety Testing (1)

Jan. 25, 2019, 3:16 PMUpdated: Jan. 25, 2019, 9:46 PM

The first Ebola treatment could be on its way to crossing the finish line, as initial testing of a taxpayer-funded experimental treatment has shown it’s safe in adults.

The promising findings of the experimental treatment known as “mAb114" appear in the Jan. 24 issue of The Lancet as the Democratic Republic of the Congo continues to grapple with an outbreak in North Kivu Province. There have been 689 cases and 422 deaths since August, according to the latest surveillance data from the World Health Organization.

While a number of experimental treatments and vaccines are in the works, the Food and Drug Administration has not yet approved any Ebola-related products.

Ridgeback Biotherapeutics announced last month that it licensed the product from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, which means the Miami-based biotechnology company will likely be submitting the application to the FDA to get mAb114 onto the market. But first, mAb114 has to make it past more clinical testing.

“These are important findings which will help to guide and shape our development plan,” Ridgeback Chief Executive Officer Wendy Holman told Bloomberg Law Jan. 25. The fact that the study demonstrates mAb114 was well tolerated and can be easily and rapidly infused “is essential for caregivers in a busy Ebola Treatment Unit. But most importantly, it is critical for patients who are in need of life saving care.”

When asked about the timing for bringing the product to market, Holman said Ridgeback and its partners “are dedicated to working as fast and carefully as possible to bring mAb114 to licensure. We look forward to collaborating with regulators to safely expedite this program for the benefit of the patients who are in such great need.”

The latest findings are based on a phase I study on 18 adults, which represents the first time researchers introduce a test product into humans to determine safety and dosing levels. The study still has to demonstrate that it’s safe and effective in phase II or phase III trials, which are larger and can take anywhere from several months to years to complete.

Scientists at the NIAID developed mAb114, and conducted and sponsored the clinical trial. Health workers in the DRC are offering mAb114 under compassionate use and as part of a phase II/III clinical trial of multiple investigational treatments, the NIAID said.

(Updates with comments from Ridgeback CEO Wendy Holman in the fifth and sixth paragraphs.)

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Randy Kubetin at rkubetin@bloomberglaw.com

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