The South African Health Products Regulatory Authority (SAHPRA) has approved the study of an orally-administered pill for patients with symptomatic Covid-19 who do not require hospital care.
Trials are currently progressing in the United States, with expansion of study sites underway to further speed up recruitment, according to RedHill Biopharma, a specialty, Nasdaq-listed biopharmaceutical company leading the trial.
Administered as a once-daily oral pill, RHB-107 acts on human serine proteases associated with preparing the spike protein for entry of the virus into target cells.
As the antiviral drug candidate is host-cell targeted, it is expected to be potentially effective against emerging viral variants of SARS-CoV-2 with spike protein mutations.
“South Africa, along with the US 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.”
“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,” said RedHill Biopharma medical director Terry Plasse.
#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