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.
Source: Company Press Release