RedHill Biopharma is set to commence the Phase II/III clinical trial of its new drug candidate, RHB-107 (upamostat) to treat non-hospitalised patients with symptomatic Covid-19 in South Africa.

The move comes after the South African Health Products Regulatory Authority (SAHPRA) granted approval to conduct the trial in the country.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The trial is currently progressing in the US, with the expansion of trial centres underway to speed up subject enrolment.

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 anticipated to be potentially effective against emerging viral variants of SARS-CoV-2 with spike protein mutations.

The two-part, multicentre, randomised, double-blind, placebo-controlled, parallel-group trial will assess the safety and efficacy of RHB-107 in symptomatic Covid-19 patients at the early stage of the disease in the out-patient setting.

The study will aid in selecting the apt dose and assess the time to a sustained recovery from illness as the primary goal.

RedHill Biopharma medical director Terry Plasse said: “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.”

In an in vitro human bronchial epithelial cell model, RHB-107 showed to robustly hinder SARS-CoV-2 viral replication.

Furthermore, the drug candidate possesses a favourable clinical safety and biodistribution profile, as shown in prior clinical trials, including several Phase I and Phase II trials for various indications, in nearly 200 subjects.

Separately, another oral drug of the company, opaganib, is being assessed in an international Phase II/III study in 475 severe Covid-19 patients in a hospital setting, with top-line data anticipated soon.

In June this year, RedHill concluded enrolment in the Phase II/III study of opaganib (Yeliva, ABC294640) in hospitalised patients with severe Covid-19 pneumonia.