Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.
—
Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations
—
RedHill preparing for potential ramp-up of manufacturing of opaganib
TEL-AVIV, Israel and RALEIGH, NC, USA I April 17, 2020 IRedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640)1, for the treatment of SARS-CoV-2 infection (COVID-19). The IND submission follows preliminary discussions with the FDA on the study design.
The proposed randomized, double-blind, placebo-controlled Phase 2a study is intended to evaluate the safety and efficacy of opaganib in up to 60 adult patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S.
“We are moving quickly to advance the clinical development of opaganib for COVID-19 and in parallel to expand access to opaganib for patients under compassionate use to help address the global pandemic caused by SARS-CoV-2,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “We are encouraged by the preliminary findings from the first patients treated with opaganib under compassionate use indicating objective clinical improvement and look forward to collaborating closely with FDA to validate the effectiveness of opaganib in treating COVID-19 in a controlled clinical setting.”
A compassionate use program with opaganib is ongoing in Israel, with five patients treated to date in a leading hospital. Preliminary findings from all five patients have shown an improved C-Reactive Protein (CRP), an inflammatory biomarker, with four of the five patients also demonstrating measurable clinical improvement, including reduced supplemental oxygenation and higher lymphocyte counts within days following treatment initiation with opaganib.
In order to facilitate access to opaganib, various programs are currently under discussion in other countries. In line with the current global shift from compassionate use programs with COVID-19 therapeutic candidates to more rigorously-controlled studies, the compassionate use program in Italy is planned to be converted to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes.
RedHill is preparing for a potential ramp-up of manufacturing of opaganib.
To find out more about RedHill Biopharma’s Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.
A total of 131 subjects have been dosed with opaganib to date in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications in the U.S., in pharmacokinetic studies in healthy volunteers in the U.S., and under the existing FDA-approved expanded access requests from physicians for individual oncology patients, establishing safety and tolerability in humans both in the U.S. and ex-U.S.
Pre-clinical data have demonstrated both anti-viral and anti-inflammatory activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Several prior pre-clinical studies support the potential role of sphingosine kinase-2 (SK2) in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza-virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury.
About Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-viral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. By inhibiting SK2, opaganib potentially blocks viral replication complex and pathological inflammation. Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors. Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19) in confirmed COVID-19 patients in Israel. The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4 and Aemcolo® for the treatment of travelers’ diarrhea in adults5. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) Opaganib (Yeliva®), a first–in–class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 1/2a study for cholangiocarcinoma; (v) RHB–106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.
SOURCE: RedHill Biopharma
Post Views: 255
Proposed study intended to evaluate the safety and efficacy of opaganib in up to 60 patients hospitalized with positive SARS-CoV-2 infection and pneumonia in the U.S.
—
Opaganib’s unique mechanism of action has both anti-viral and anti-inflammatory activities, targeting a critical host factor, minimizing potential development of resistance due to viral mutations
—
RedHill preparing for potential ramp-up of manufacturing of opaganib
TEL-AVIV, Israel and RALEIGH, NC, USA I April 17, 2020 IRedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to study its investigational drug, opaganib (Yeliva®, ABC294640)1, for the treatment of SARS-CoV-2 infection (COVID-19). The IND submission follows preliminary discussions with the FDA on the study design.
The proposed randomized, double-blind, placebo-controlled Phase 2a study is intended to evaluate the safety and efficacy of opaganib in up to 60 adult patients hospitalized with positive SARS-CoV-2 and pneumonia in the U.S.
“We are moving quickly to advance the clinical development of opaganib for COVID-19 and in parallel to expand access to opaganib for patients under compassionate use to help address the global pandemic caused by SARS-CoV-2,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “We are encouraged by the preliminary findings from the first patients treated with opaganib under compassionate use indicating objective clinical improvement and look forward to collaborating closely with FDA to validate the effectiveness of opaganib in treating COVID-19 in a controlled clinical setting.”
A compassionate use program with opaganib is ongoing in Israel, with five patients treated to date in a leading hospital. Preliminary findings from all five patients have shown an improved C-Reactive Protein (CRP), an inflammatory biomarker, with four of the five patients also demonstrating measurable clinical improvement, including reduced supplemental oxygenation and higher lymphocyte counts within days following treatment initiation with opaganib.
In order to facilitate access to opaganib, various programs are currently under discussion in other countries. In line with the current global shift from compassionate use programs with COVID-19 therapeutic candidates to more rigorously-controlled studies, the compassionate use program in Italy is planned to be converted to a clinical study in order to generate more robust clinical data in a controlled setting for regulatory purposes.
RedHill is preparing for a potential ramp-up of manufacturing of opaganib.
To find out more about RedHill Biopharma’s Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.
A total of 131 subjects have been dosed with opaganib to date in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications in the U.S., in pharmacokinetic studies in healthy volunteers in the U.S., and under the existing FDA-approved expanded access requests from physicians for individual oncology patients, establishing safety and tolerability in humans both in the U.S. and ex-U.S.
Pre-clinical data have demonstrated both anti-viral and anti-inflammatory activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Several prior pre-clinical studies support the potential role of sphingosine kinase-2 (SK2) in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza-virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury.
About Opaganib (ABC294640, Yeliva®)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-viral and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. By inhibiting SK2, opaganib potentially blocks viral replication complex and pathological inflammation. Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors. Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19) in confirmed COVID-19 patients in Israel. The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4 and Aemcolo® for the treatment of travelers’ diarrhea in adults5. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) Opaganib (Yeliva®), a first–in–class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 1/2a study for cholangiocarcinoma; (v) RHB–106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.
SOURCE: RedHill Biopharma
Post Views: 255
