The South African Health Products Regulatory Authority (Sahpra) approved the second and third phase study of RHB-107, a once-daily medication for non-hospitalised patients with symptomatic Covid-19.
RedHill Biopharma Ltd., the company developing the medication, announced today that South Africa had joined the US in approving the study.
In parallel, RedHill’s oral Covid-19 therapeutic, called opaganib, is being evaluated in a global phase 2/3 study in 475 patients hospitalized with severe Covid-19.
RHB-107 is being developed as a potential treatment with a once-daily oral pill during the early stages of a Covid-19 infection.
The study — designed to assess dosage and recovery time — is already in progress in the US.
RHB-107 is an antiviral drug that targets a virus’ method of entry into target cells.
The once-daily pill is expected to be effective against new viral variants and is proven to inhibit replication of SARS-CoV-2 in a human bronchial epithelial cell model.
#RDHL accelerates its ongoing US Phase 2/3 study with oral RHB-107 in non-hospitalized #COVID19 patients with @SAHPRA1 approval to expand the study to #SouthAfrica. Read the $RDHL PR: https://t.co/54ufSgzjoZ
— RedHill Biopharma (@RedHillBio) September 13, 2021
Redhill Biopharma said RHB-107 is clinically safe, as demonstrated in previous clinical studies with approximately 200 patients.
“South Africa continues to face an onslaught of Covid-19 that is claiming many lives and causing significant distress to the healthcare system,” said Terry Plasse, Medical Director at RedHill.
“South Africa, along with the U.S. and rest of the world, urgently need the ability to easily and effectively treat Covid-19 and its variants, both inside and outside the hospital setting.”
“As clearly highlighted recently by the Director of NIAID, it is important to be able to treat patients early in the course of the disease to prevent progression to more severe symptoms.”
“The approval of this study in South Africa, along with the expansion of study sites in the US, are aimed at accelerating our efforts to bring RedHill’s two novel, oral compounds that cover the spectrum of Covid-19 disease severity, RHB-107 and opaganib, to patients across the world.”