Redhill Biopharma announces approval for compassionate treatment with Opaganib in corona patients in Italy

At the same time, the company announced the provision of similar compassionate treatment to one patient in Israel, about 160 patients with life-threatening clinical symptoms are expected to receive the treatment in three hospitals in northern Italy

Redhill Biopharma, which focuses on patented drugs for the treatment of diseases related to the digestive tract, announced today that it has received approval from the Italian National Center for Infectious Diseases and the Central Ethics Committee in Italy to provide compassionate care with opaganib (Yeliva, ABC294640), the company's experimental drug, to patients who have been diagnosed with COVID-19 and are suffering from life-threatening clinical symptoms. The approval to provide compassionate care was obtained with the help of Cosmo Pharmaceuticals, Redhill's strategic partner.

About 160 patients with life-threatening clinical symptoms are expected to receive treatment at three leading hospitals in northern Italy. A program to provide compassionate care is also taking place in Israel, where the treatment was given to the first patient in a leading hospital. Redhill is holding talks regarding COVID-19 in the US and other countries and at the same time making preparations to increase the production potential of opaganib.

"The approval received in Italy for providing compassionate treatment with opaganib allows doctors in three central hospitals in Italy to treat patients who are at high risk of developing pneumonia and patients suffering from pneumonia, including patients suffering from acute respiratory distress syndrome as a result of SARS-CoV-2 infection," said D Rabbi Mark L. Levitt, MD, Ph.D., Medical Director at Redhill. "Redhill is constantly working to explore the potential of opaganib as a treatment for COVID-19 in order to help patients around the world who need a treatment option. I would like to thank our partners at Cosmo Pharmaceuticals for their important support throughout the process in Italy."

To date, 131 patients have been treated with the drug opaganib, in a way that establishes the safety and tolerability of the drug, as part of phase 1 and phase 2 trials for the treatment of cancer indications in the USA, as well as in pharmacokinetic trials with healthy volunteers and compassionate treatments in cancer patients at the request of doctors, under the Expanded Access program Approved by the FDA.
Opaganib is an innovative drug under development, inhibiting the SK2 enzyme by oral administration. Preclinical experiments demonstrated both antiviral and anti-inflammatory activity of the drug with the potential to reduce inflammatory damage to the lungs, such as pneumonia. Several preclinical experiments indicate the potential involvement of SK2 in the transcription process of viruses of similar types to the corona virus family and the inhibition of the SK2 enzyme can potentially lead to the inhibition of viral replication. Preclinical experiments in an animal model showed that the drug opaganib reduced mortality rates as a result of infection with the influenza virus (flu) and also showed an improvement in pneumonia in an animal model.