RedHill Biopharma Ltd. received approval from Brazil’s health regulator for its global Phase 2/3 study, which evaluates its proprietary inhibitor called opaganib in patients hospitalized with severe COVID-19 pneumonia.
RedHill Biopharma (RDHL) said that the approval by the Brazilian Health Regulatory Agency (ANVISA), which is for its global randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study, has a target of enrolling up to 270 patients requiring hospitalization and treatment with supplemental oxygen.
Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance.
“In recently announced preclinical results, opaganib demonstrated its ability to stop SARS-CoV-2 viral replication in its tracks – preventing its ability to spread and cause damage to other cells which, together with its potent anti-inflammatory mechanism, supports the rapid progress of our global Phase 2/3 and U.S. Phase 2 studies,” said RedHill’s Chief Operating Officer Gilead Raday. “Brazil continues to experience a significant number of COVID-19 cases and its addition is expected to further accelerate the global Phase 2/3 study with opaganib.”
The study has been approved in Brazil, Israel, UK, Italy, Russia and Mexico, with further plans of expansion.
RedHill Biopharma said that its randomized, double-blind, placebo-controlled US Phase 2 study with opaganib in patients with severe COVID-19 pneumonia is approximately 75% enrolled. Full enrollment is set to be completed in coming weeks, the company said.
In addition, the biopharma company is in discussions with US government agencies for potential funding to support the advancement of opaganib toward emergency use approval.
Shares in RedHill Biopharma have already increased 73% so far this year, while scoring a Buy rating from Wall Street analysts Robert Hazlett at BTIG and Scott Henry at Roth Capital. That’s with a $21 average analyst price target, which implies 101% upside potential for the stock in the coming 12 months.
BTIG’s Hazlett, who has a $26 price target on RDHL, believes the company has reached critical mass in establishing a vertically-integrated GI-focused biopharmaceutical firm, achieving three ” approved products” that become the “bedrock” of its commercial organization.
The analyst added that RedHill Biopharma offers “potential material near-term growth” and long-term optionality through its broad pipeline.
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