Biotechs Fast Track Repurposing Existing Drugs for COVID-19 Treatments

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, April 8, 2020 /PRNewswire/ -- The search for vaccines and treatments for the global health crises is now focusing on medicines that are presently approved for other ailments. A recent article in the LA Times discussed this issue saying that when a pandemic springs up as fast as the one sparked by the novel coronavirus, doctors must rummage around in their medicine cabinets for drugs that are already available and might be repurposed to treat a wholly new disease. Treating patients with mild or moderate COVID-19 is essentially a preventive mission: The principal aim is to stop the disease from progressing to a severe stage that would typically require mechanical ventilation. But it's hard to slow or disrupt the progress of an infection when you have only begun to see how it unfolds. And it's inherently difficult to prove that a particular medicine has prevented severe illness or death when neither was never a sure bet in the first place. Given the lack of other good options, doctors are forced to try these medicines anyway.  The article continued; "Among the best known are several antiviral medications — remdesivir, lopinavir and ritonavir — that were developed to treat Ebola and AIDS. All of those medications are the focus of a U.S.-sponsored international trial with as many as 60 sites. It could begin producing preliminary results in the coming weeks, said one of its principal investigators, Dr. Andre Kalil of the University of Nebraska Medical Center.  Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Akers Biosciences, Inc. (NASDAQ: AKER), Abbott Laboratories (NYSE: ABT), Pluristem Therapeutics Inc. (NASDAQ: PSTI), Gilead Sciences, Inc. (NASDAQ: GILD).

The World Health Organization has called remdesivir, which was developed (but failed) to treat Ebola, the "most promising" antiviral to treat COVID-19. It was widely used on patients in China, and the results of clinical trials conducted there are also expected in the coming weeks.  Gilead Sciences Inc., which makes remdesivir, is also sponsoring a major trial of its drug at 93 sites, including 18 in California… (the) drugs chloroquine and hydroxychloroquine, used to treat malaria, rheumatoid arthritis and the autoimmune disease lupus, (are being discussed) as a potential "game changer." And they, too, are being tested as a treatment for moderate COVID-19 cases in two U.S. trials and many more around the world."  The article concluded: "There's also a passel of less celebrated drugs and therapies that are being tested in the United States and abroad. Some seem like a shot in the dark. Some are dangerous. And a few are truly promising.

Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS:  Moleculin Announces Active Compound in WP1122 Reduces Coronavirus Replication In Vitro by 100% - Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates, today announced that independent research found 2-deoxy-D-glucose ("2-DG") to reduce replication of SARS-CoV-2, the virus that causes COVID-19, by 100% in in vitro testing.

Researchers at the University of Frankfurt disclosed the findings in their article submitted to NatureResearch on March 11, 2020 (Bojkova, D et al; DOI: 10.21203/rs.3.rs-17218/v1) (https://www.researchsquare.com/article/rs-17218/v1). The authors reported that inhibiting glycolysis with non-toxic concentrations of 2-DG completely prevented SARS-CoV–2 replication in Caco–2 cells.  Glycolysis is a process by which cells convert glucose into energy and infected (host) cells are induced by viruses to dramatically increase their dependence on glycolysis.  2-DG inhibits glycolysis because, although it appears to cells to be glucose, it is in fact a decoy that cannot be converted into energy.

Moleculin's drug candidate, WP1122, is referred to as a "prodrug" of 2-DG whereby chemical elements are added to 2-DG to improve its delivery in vivo.  Once administered, these added elements are removed by normal metabolic processes and what remains is 2-DG. As a result, 2-DG is the active compound in WP1122.  In chemical terms, it is referred to as the active "moiety" (subpart) of WP1122.

"This is the breakthrough we were looking for, only it came from an unexpected source," commented Walter Klemp, Chairman and CEO of Moleculin. "Normally, we wouldn't have access to data like this until it is published, but the willingness of the authors to pre-release this data will help support our development of WP1122 for treating COVID-19."

Dr. Don Picker, Chief Science Officer of Moleculin explained: "2-DG is what we call the 'active moiety' in WP1122.  The problem with 2-DG is that it is metabolized by the body too quickly, so you can't get enough concentration in human tissues and organs to be therapeutic.  Therefore, even though 2-DG is active against a range of viruses, including SARS-CoV-2, it isn't useful as a clinical therapy because it's too rapidly metabolized.  WP1122 appears to solve this problem because it is a 'prodrug' of 2-DG.  It's structure enables it to achieve much higher tissue/organ concentrations than 2-DG alone, but once it's in the cell, it metabolizes into the exact same 2-DG that is so effective in vitro."

Moleculin's Chief Medical Officer – New Projects, Dr. Sandra Silberman added: "The FDA has cleared the way for very rapid development of COVID-19 therapies, so we should be able to move WP1122 into the clinics on an expedited basis.  Fortunately, it has a very good safety profile in mice.  We are in the process of demonstrating safety in additional species before submitting our IND (Investigational New Drug application).  Since it has better drug-like properties than 2-DG, WP1122 also actually works better in the animal tumor models we have been studying. We think this bodes well for its potential as a more potent drug than 2-DG as an antiviral agent against coronavirus."    Read this full release and more news for MBRX at:  https://www.financialnewsmedia.com/news-mbrx/

Other recent developments in the biotech industry include:

Akers Biosciences, Inc. (NASDAQ: AKER) recently announced that its collaboration with Premas Biotech has successfully completed the milestone of obtaining clones of all three coronavirus antigens, Spike (S), Envelope (E), and Membrane (M) that they have selected for their vaccine candidate.

The clone development process has four primary steps including first, the design and synthesis of the genes; second, the selection of the right host; third, the insertion of the gene into the host; and fourth, the verification that the clone has the right gene, and all characteristics are correct.

Abbott Laboratories (NYSE: ABT) recently announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test will run on the company's ID NOW^™ platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.

The ID NOW platform is small, lightweight (6.6 pounds) and portable (the size of a small toaster), and uses molecular technology, which is valued by clinicians and the scientific community for its high degree of accuracy. ID NOW is already the most widely available molecular point-of-care testing platform in the U.S. today. 

Pluristem Therapeutics Inc. (NASDAQ: PSTI)  announced preliminary data from its compassionate use program, treating seven patients suffering from acute respiratory failure and inflammatory complications associated with COVID-19 with Pluristem's PLX cells, in three medical centers in Israel. 

All seven patients approved for treatment under compassionate use program with PLX cells exhibited, prior to treatment, respiratory failure due to ARDS, which is a major cause of mortality and required mechanical ventilation in an ICU. Four of the patients also demonstrated failure of other organ systems, including cardiovascular and kidney failure, indicating critical disease and poor prognosis.  

Gilead Sciences, Inc. (NASDAQ: GILD) recently  announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 (novel coronavirus). These randomized, open-label, multicenter studies will enroll approximately 1,000 patients at medical centers primarily across Asian countries, as well as other countries globally with high numbers of diagnosed cases, beginning in March. The studies will assess two dosing durations of remdesivir, administered intravenously. The initiation of these studies follows the U.S. Food and Drug Administration's (FDA) rapid review and acceptance of Gilead's investigational new drug (IND) filing for remdesivir for the treatment of COVID-19.

The new clinical studies expand the ongoing research into remdesivir, which includes two clinical trials in China's Hubeiprovince led by the China-Japan Friendship Hospital as well as the recently initiated clinical trial in the United States led by the National Institute of Allergy and Infectious Diseases (NIAID). Gilead has donated drug and provided scientific input for these studies, with results from those in China expected in April.

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