Experimental MERS treatment enters early-stage clinical trial
An early-stage clinical trial will test the safety of two human monoclonal antibodies as a targeted treatment for people infected with Middle East respiratory syndrome coronavirus, or MERS-CoV.
According to a press release from NIH, the study is sponsored by the National Institute of Allergy and Infectious Diseases, and trial enrollment has already begun.
“Currently, we lack specific treatments for MERS,” Anthony S. Fauci, MD, NIAID director, said in the release. “Having targeted therapeutics available to treat this unpredictable and frequently fatal respiratory disease would help us reduce MERS-associated deaths and control future outbreaks.”
The first MERS-CoV case was recorded in Jordan in 2012 and has since spread to 27 other countries. As of May 2, WHO reports 2,206 laboratory-confirmed cases and, with 787 deaths, a fatality rate of 36%.
The monoclonal antibodies (mABs) REGN3048 and REGN3051 were initially tested in a mouse model of MERS, which found that the mABs have an ability to neutralize MERS-CoV.
The blinded study will be the first to test these specific mABs in people and will enroll 48 healthy adults aged 18 to 45 years. Participants will be split into six cohorts of eight, allowing researchers to test both mABs in increasing doses. The first cohort will receive the lowest dose at 1.5 mg of each mAB per kilogram of participants’ body weight, and subsequent cohorts will receive increased dosages, with the sixth cohort receiving the highest dosage at 75 mg/kg of each mAB. Each mAB will be delivered intravenously to six participants in every cohort, and the remaining two participants will receive an inactive placebo, according to the release.
Trial continuation and escalating mAB dosages will be determined by an independent safety review committee based on trial safety and tolerability data.
The study is projected to be concluded by June 2019.
For more information about the trial go to: https://clinicaltrials.gov/ct2/show/NCT03301090?id=NCT03301090&rank=1
Disclosure: Fauci works for NIAID.