Frontier Scientific Develops and Provides Process to Produce Active Pharmaceutical Ingredient for Clinical Trial of COVID-19 Therapeutic Investigational Drug RBT-9
Published: Jun 23, 2020
June 23, 2020 12:00 UTC
-Renibus Therapeutics Will Conduct Phase 2 Trial of Compound with Antiviral and Immune-Modulating Activity to treat effects of COVID-19 -
LOGAN, Utah--(BUSINESS WIRE)--?Frontier Scientific Inc.?a world leader in porphyrin chemistry and chemical building blocks for drug discovery and material science research, today announced their collaboration with Renibus Therapuetics to develop a therapeutic for COVID-19. Frontier Scientific identified and developed multiple synthetic processes to produce stannous protoporphyrin (SnPP) ? the active pharmaceutical ingredient of RBT-9, an investigational drug entering a Phase 2 trial for the treatment of COVID-19 patients who are at high risk of deteriorating health due to age or comorbid conditions such as kidney or cardiovascular disease. RBT-9, which has been awarded Fast Track designation by the U.S. Food and Drug Administration (FDA), has demonstrated both antiviral and immune-modulating activities in preclinical studies.
RBT-9 is being developed by Renibus Therapeutics as an antiviral agent with organ-protective attributes. With the advent of the coronavirus pandemic, Renibus scientists moved quickly to plan and initiate a clinical trial of RBT-9 in COVID-19 patients. They chose Frontier Scientific to develop a scalable process with robust chemical techniques allowing RBT-9 to be produced under cGMP protocols for use in human clinical trials, said Dustin Cefalo, PhD, VP of Porphyrin Chemistry at Frontier Scientific.
Al Guillem, CEO of Renibus, stated, ?Renibus Therapeutics Inc., is pleased to be partnering with Frontier Scientific on the manufacturing and supply of RBT-9 for study REN-005 ?A Phase 2, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-9 on Preventing Progression of COVID-19 in High-Risk Individuals.? Frontier Scientific?s ability to quickly react and support our clinical study efforts during these critical times is a testament to their commitment to deliver superior service and support to their partners.?
Upon development of the synthetic process for production of SnPP, Frontier Scientific transferred their processes and know-how to an outside GMP facility for production of the active pharmaceutical ingredient for Renibus Therapeutics. Frontier Scientific continues to provide technical consultation and problem-solving expertise to Renibus Therapeutics with regards to production of SnPP and support the continued development of RBT-9 as a promising therapeutic for the treatment of COVID-19.
About Renibus Therapeutics and RBT-9?: Renibus Therapeutics is developing a novel anti-viral therapy, RBT-9 (stannous protoporphyrin?SnPP), for the treatment of COVID-19 in early stage patients who are asymptomatic or mildly symptomatic and at high risk for disease progression. Renibus is investigating the ability of RBT-9 both to inhibit viral activity and to prevent organ failure in COVID-19 patients. For more information visit?https://renibus.com/#contact.
About Frontier Scientific:??Frontier Scientific specializes in research and development, custom synthesis, process development, scale-up, and quality manufacturing of specialized compounds and fine chemicals. Our skilled chemists have developed compounds for use in drug discovery, FDA approved medical devices, and in chemical and life sciences research. It has been our philosophy for over 40 years that innovative solutions and accountability to our clients are key components of successful custom research projects. We view quality as a guiding principle, achieved by rigorous scientific diligence at each step of the development and manufacturing process. Frontier Scientific is headquartered in Logan, UT. For more information, visit?https://www.frontiersci.com.
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Contacts
Frontier Scientific, Inc:
Mark L Nelson, PhD, VP of Business and Science Development,?mnelson@frontiersci.com, 1-435-753-1901
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