Israeli biopharmaceutical firm RedHill Biopharma Ltd. on Monday said that COVID-19 patients treated with its Opaganib drug in an experimental program in Israel showed improvement within days of starting treatment.
The two patients showed decreased oxygen requirements, decreased levels of C-reactive proteins, indicating reduced inflammation, and increased levels of lymphocytes, a type of white blood cell.
Both patients had confirmed coronavirus infections prior to the treatment, which was carried out in unnamed Israeli hospitals. One of the patients was in the ICU and released a few days after starting treatment.
The drug was administered alongside standard of care procedures, including hydroxychloroquine background therapy, Redhill said.
“Our hope is that the unique mechanism of action of Opaganib, with both anti-viral and anti-inflammatory activity, will help COVID-19 patients by reducing lung inflammation, and thus preventing the disease from progressing to a stage which requires mechanical ventilation,” said Mark L. Levitt, RedHill’s medical director.
It is important to note that correlation and causation are often separate — the two patients could have improved equally, or more, without the Opaganib treatment, and a sample size of two has little implication for the general population. In other words, don’t get your hopes up.
The drug has the potential to treat symptoms of COVID-19, the disease caused by the novel coronavirus, but is not a vaccine or meant to build immunity or prevent infections in any way.
The patients took the drug under compassionate use guidelines with approval from the Health Ministry. Compassionate use is when medical personnel treat patients with experimental drugs outside of clinical trials, under special circumstances, and with the approval of medical authorities.
Opaganib is an investigational drug, meaning it has undergone testing, but has not yet been approved for widespread use.
The drug is administered orally, is aimed at treating cancer, inflammation and gastrointestinal issues, and carries out antiviral activities. It is is a selective inhibitor that targets the protein sphingosine kinase-2, which can hamper cancer growth and pathological inflammation, and could block viral replication.
It has been tested on non-COVID-19 subjects in the US in ongoing and completed Phase 1 and Phase 2 clinical trials. Redhill mainly focuses on gastrointestinal diseases.
Opaganib was tested in a Phase 1 clinical study on patients with advanced solid tumors and is being investigated for the treatment of bile duct cancer, both individually and in combination with hydroxychloroquine, a drug touted by the White House as a potential coronavirus treatment, against the advice of medical officials. Opaganib is also in a Phase 2 study for the treatment of prostate cancer.
“The treatment of COVID-19 patients with Opaganib is supported by pre-clinical data demonstrating its unique anti-viral activity in a number of other viruses, as well as its anti-inflammatory activities and potential to reduce lung inflammation. In addition, clinical data to date have indicated safety and tolerability in healthy volunteers and cancer patients,” Levitt said.
Separately, Italian authorities approved Opaganib for use on some 160 COVID-19 patients with life-threatening symptoms at three hospitals in northern Italy under compassionate use guidelines, Redhill said last week. The trials have not yet started.
The Italian National Institute for Infectious Diseases and Central Italian Ethics Committee approved the drug for immediate use.
Redhill is preparing to ramp-up manufacturing of Opaganib and is holding talks with the US and other countries about its potential use in the pandemic. Pre-clinical data found that the drug had the potential to reduce pneumonia, which is responsible for many COVID-19 deaths.
Redhill shares, which trade on the Nasdaq under the ticker RDHL, have skyrocketed over 100 percent in the past several weeks. The company is based in Tel Aviv and Raleigh, North Carolina.
RedHill was founded in 2009 by Dror Ben-Asher and Ori Shilo, two kibbutz dwellers turned investment bankers and entrepreneurs.