Los Angeles, CA /PRNewswire/ - In collaboration with scientists at the National Institute of Infectious Diseases (NIID) in Tokyo, Japan, MAX BioPharma (www.maxbiopharma.com) scientists have identified new substances with antiviral activity against the novel coronavirus, SARS-CoV-2, the virus that caused the ongoing global COVID-19 pandemic (www.biorxiv.org/content/10.1101/2021.01.31.429001v1).
These new substances, so-called semi-synthetic oxysterols, were derived from a collection of sterol molecules created by MAX BioPharma, as part of its Oxysterol Therapeutics® platform technology that has produced oxysterol-based drug candidates in other therapeutic indications, including cancer, fibrosis, and bone formation.
The studies, performed over the past 12 months, identified several promising oxysterol-based lead compounds that robustly inhibit the replication of the SARS-CoV-2 virus by more than 99% in host cells with potencies comparable to established antiviral medications, such as Remdesivir (RDV), but through a different biological mechanism. Unlike RDV, which must be given by intravenous injection, oxysterol-based compounds can often be administered orally and have previously shown favorable safety and pharmacokinetic profiles. These oxysterols act on host cells and not the virus, and are expected to remain effective even as the virus mutates.
"Despite the vaccines that have been produced to target Covid-19, given the apparent difficulties in mass producing these vaccines, the potential need for frequent vaccination, and the fact that they may not work on new mutants of the virus, there is an urgent need for therapies that can treat Covid-19 in an effective, patient friendly, safe, and cost-effective manner," states Dr. Farhad Parhami, Founder, President and CEO of MAX BioPharma. The preclinical in vitro studies so far have been conducted in the laboratory of Dr. Koichi Watashi at the NIID, Japan. "These oxysterols inhibit viral replication in the concentration ranges achievable by oral administration in mice. Since their mode of action is different, they can be used also in multidrug treatment with other drugs such as RDV for more efficient therapy," states Dr. Watashi.
"Oxysterols are a class of understudied molecules. As a chemist, I am fascinated by the wide range of biological activities that naturally occurring oxysterols can achieve. We can often improve selectivity, potency, and drug-like properties of naturally occurring oxysterols by introducing small changes in their molecular structures, and the resulting semi-synthetic oxysterols can serve as promising drug candidates," says Dr. Frank Stappenbeck, Director of Chemistry at MAX BioPharma.
As a next step, MAX BioPharma and NIID, plan to perform in vivo efficacy studies in animal models of Covid-19, using the most promising drug candidates. Going forward, MAX BioPharma is seeking strategic partnerships with biotechnology and pharmaceutical companies that have the expertise and resources to further the development of oxysterol-based drug candidates towards FDA approval and commercialization.
In addition, MAX BioPharma is in the process of raising a series A financing round to support the advancement of its therapeutic development programs. "We are very excited and hopeful that our efforts will result in an effective and safe therapy for Covid-19 that can be prescribed to patients at the earliest signs of infection, to those with increased risk of developing severe disease, and to those that are in close contact with infected patients as a prophylactic therapy. This will significantly improve the management of the Covid-19 infection now and in the future." says Dr. Parhami.
About MAX BioPharma, Inc.
MAX BioPharma is a privately-held preclinical stage California-based biopharmaceutical company developing novel lipid molecules as drug candidates for debilitating and fatal human diseases. The company has created the Oxysterol Therapeutics® platform, which is applicable across numerous therapeutic indications, and is leveraging a robust and growing intellectual property portfolio. MAX BioPharma's first entry into this area was through the discovery of novel osteogenic oxysterol compounds that target multipotent mesenchymal cells, including mesenchymal stem cells, to induce the formation of bone-forming osteoblasts and bone. The company is translating this technology into the next generation of therapeutic agents for stimulation of bone formation, locally and systemically, in indications such as spinal fusion, non-union fractures, and osteoporosis. MAX BioPharma is also pursuing the development of small molecule oxysterols that function as anti-tumorigenic Hedgehog and TGFb pathway antagonists that will be more effective than currently known antagonists in treating a variety of cancers, including lung, blood and pancreatic cancer, as well as fibrotic diseases of liver, lung, and kidney, in addition to those that have antiviral activity against hepatitis B and C viruses and coronaviruses. For more information, please visit us at www.maxbiopharma.com.