An Israel-based biopharmaceutical company with commercial headquarters in the United States, Canada and Europe has announced good news on the compassionate use of its investigational drug, opaganib (YelivaTM, ABC294640), in patients with confirmed COVID-19 novel coronavirus infection in Israel.
At the time of treatment initiation, all of the patients were hospitalized, suffered from moderate-to-severe acute respiratory symptoms related to SARS-CoV-2 infection and were treated with standard-of-care (mostly hydroxychloroquine). All patients required supplemental oxygenation and were hypoxic despite being treated with supplemental oxygen.
Preliminary findings from all six patients analyzed have shown that all the patients demonstrated objective significant measurable clinical improvement within days following treatment initiation with opaganib, including a decrease in required supplemental oxygenation, higher lymphocyte counts, a sign of improvement from virus-induced lymphopenia, and decreased C-reactive protein (CRP) levels, an important inflammatory biomarker correlated with lung lesions which could reflect disease severity2. Opaganib was well tolerated and showed clinical improvement both with and without hydroxychloroquine.
Five of the six patients analyzed were weaned from oxygen, and three were discharged from the hospital within days of treatment initiation. The 6th patient, whose therapy was initiated more recently, is improving. To date, two patients have safely completed 14 days of opaganib therapy, which has been well tolerated.
A seventh patient who was treated with hydroxychloroquine and azithromycin suffered from side effects of diarrhea, which resolved quickly following cessation of all therapies. This patient received only one day of opaganib dosing and therefore was not included in this analysis.
“These preliminary findings are highly encouraging, show clinical improvement in the first COVID-19 patients treated with opaganib and provide preliminary support for the tolerability of opaganib and its potential efficacy in COVID-19 patients,” said Mark L. Levitt, MD, PhD, Medical Director at RedHill.
“We have submitted to the FDA an application to initiate a clinical study with opaganib in the U.S. and are also working on expanding access to opaganib through compassionate use and clinical programs in additional countries.”
To find out more about RedHill Biopharma’s Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.
RedHill recently also announced that it has submitted an Investigational New Drug (IND) application to the FDA to evaluate the safety and efficacy of opaganib in a randomized, double-blind, placebo-controlled Phase 2a study in patients hospitalized with positive SARS-CoV-2 (COVID-19) and pneumonia in the United States.
Pre-clinical data have demonstrated both anti-inflammatory and anti-viral activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage.
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 US-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 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 US federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the US Department of Defense and the FDA Office of Orphan Products Development.