National Treasure Investment Firm Redhill Biopharma Announces Progress of Phase 2/3 Clinical Trials for Oral COVID-19 Treatment

[Asia Economy Reporter Jang Hyowon] RedHill Biopharma Ltd., a US/Israel-based specialized biopharmaceutical company in which KOSPI-listed Kukbo Co., Ltd. has acquired shares, announced on the 15th the progress of its Phase 2/3 clinical trial for an oral COVID-19 treatment.

RedHill stated that it has completed recruitment for Part A of the Phase 2/3 study of RHB-107 (upamostat), an oral once-daily treatment for COVID-19 patients with symptoms who do not require hospital care. This study is being conducted in the US and South Africa, aiming to evaluate the treatment of symptomatic COVID-19 patients early in the disease course with a once-daily oral therapy that can be prescribed and used in non-hospitalized patient populations.

Additionally, RedHill officials announced that the topline results and dose selection (200mg or 400mg) for Part A of the study, designed to assess the safety and tolerability of RHB-107 (upamostat), are expected to be released in the first quarter of 2022.

Terry F. Plasse MD, Medical Director of RedHill, said, “With COVID-19 infections rising again in many countries worldwide, RedHill recognizes the importance of an effective, simple, and safe oral therapy that can be used outside the hospital and act across COVID-19 variants. Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step toward a new once-daily oral pill as a potential community treatment for COVID-19.”

RHB-107 is known as a novel antiviral drug candidate targeting human serine proteases involved in spike protein priming for viral entry into target cells. It has demonstrated a strong clinical safety and biodistribution profile in previous clinical studies, including multiple Phase 1 and 2 trials involving approximately 200 patients across various indications.

Furthermore, data packages for RedHill’s other oral COVID-19 drug candidate, opaganib, have been submitted to regulatory agencies in the US, EU, UK, and other regions ahead of planned regulatory consultations. The global Phase 2/3 study of opaganib in hospitalized patients with severe COVID-19 shows a 62% reduction in mortality in a subgroup of 251 moderately severe patients (54% of clinical participants), along with improved clinical outcomes such as reduced time on supplemental oxygen and shorter time to discharge.

Meanwhile, Kukbo announced on the 8th that it acquired shares in RedHill and was granted the exclusive negotiation rights for distribution rights contracts covering not only the domestic distribution of RedHill’s oral COVID-19 treatment under development but also distribution across major Asian regions.

This content was produced with the assistance of AI translation services.