Sen-Jam's COVID Therapeutic Receives Final Approval from NHRC to Commence their Clinical Trial in Partnership with Duke University School of Medicine
This past Friday at 5:19am, Sen-Jam Pharmaceutical in partnership with Duke University School of Medicine received full approval from the Nepal Health Research Committee to begin dosing for (SJP-oo2C); a promising COVID-19 therapeutic embarking on important Clinical Trials.
The press release that will be hitting the global market Tuesday is shared for your early benefit here:
Huntington, NY February 22, 2022—Sen-Jam Pharmaceutical, a nimble innovative startup revolutionizing inflammation out of New York, is partnering with researchers from Duke University School of Medicine (Durham, NC, USA) and Duke-NUS Medical School (Singapore) to find safe and effective oral treatments for the COVID-19 global pandemic. The collaboration received official approval this past Friday from the Nepal Health Research Council and is now commencing Phase II Clinical Trials for a novel oral therapy to mitigate the symptoms and hospitalizations associated with COVID-19.
Excessive inflammation is a hallmark of severe COVID-19. When confronted with the virus, the immune system can enter a hyper-inflammatory state as a “cytokine storm,” producing uncontrolled inflammation throughout the body leading to acute respiratory distress syndrome (ARDS) and death. Dr. Alexander T. Limkakeng Jr., MD, MHSc, FACEP, Professor, Vice Chief of Research and Director, Acute Care Research at Duke Emergency Medicine has seen firsthand the spiraling impact of COVID-19 inflammation.
Dr. Limkakeng said the study drug is aimed at this inflammatory response. “It's widely understood that severe COVID-19 illness involves a dysregulated, hyperactive immune response and that early treatment (including being vaccinated) may prevent those responses. This treatment specifically targets one kind of immune cells called mast cells, which studies have indicated might be implicated.”
Dr. Ashley Lauren St. John, a colleague of Dr. Limkakeng and an Associate Professor at Duke-NUS Medical School, is an expert in the immune response during viral infections. She is the principal investigator at the Laboratory of Immunity and Immune Pathology under Duke-NUS’ Emerging Infectious Diseases Programme. Dr. St. John said, “The collateral damage to the lung &ssue caused by inflammation is the major obstacle to recovery from COVID-19 and so we are hopeful a targeted approach to reduce inflammation could potentially improve health outcomes.”
Currently there are no options for de-railing COVID inflammation before its gets out of control. Steroidal drugs are used for those in a COVID-induced cytokine storm, but the effects are moderate and when patients have not yet been hospitalized with severe disease, steroids are ineffective. While big pharma names such as Merck, Pfizer, and Atea Pharmaceuticals are rushing to develop at-home oral treatments, Registered Pharmacist and founder of Sen-Jam Pharmaceutical Jacqueline Iversen proposed to work together to test two drug molecules, both with long histories of safety and efficacy, that when combined, appear to disrupt the body's inflammatory process which triggers COVID's runaway inflammation. Jackie believes that this oral combination, SJP-002C, will be shown to be safe for home use alone or in conjunction with an&-viral therapies. "Steroid-induced immune suppression could also inhibit adaptive immune responses, potentially limiting recovery and immune memory that could be required to prevent future infection,” Iversen said.
Sen-Jam's investigational therapeutic for the treatment of COVID-19, SJP-002C is scheduled to begin a clinical trial this month under a co-development agreement with Duke-NUS. Dr. Limkakeng said, "the study design has several unique features, including using a combination therapy that is widely available as an approved drug in countries around the world; has a known safety profile and well-understood mechanism of action of its individual components; has been studied in other viral illnesses; and could have complementary effects, with one agent potentially reducing the known side effects of the other.”
About Sen-Jam Pharmaceu:cal
At Sen-Jam Pharmaceutical we disrupt pain and inflammation. Sen-Jam Pharmaceutical's mission is to improve societal wellbeing by developing therapeutics that are safe, efficacious, and accessible by all. Sen-Jam repurposes small molecules to develop novel therapeutics for large unmet needs with a focus on improving clinical outcomes. Using patented proprietary technology and the accelerated 505(b)2 pathway, Sen-Jam is on a mission to revolutionize pain treatment and the business of pain relief. Investor information available at Wefunder. Learn more at www.sen-jam.com.
We could not be more thrilled by this development and wanted to share the news with our WeFunder family of Investors and Followers.
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