Cascade Chemistry, a contract development and manufacturing organization (CDMO) serving the pharmaceutical industry, will produce the active pharmaceutical ingredient (API) for RBT-9 on behalf of client Renibus Therapeutics. The investigational therapy is entering a Phase II trial for COVID-19 patients at high risk due to age or comorbid conditions (such as kidney or cardiovascular disease).
RBT-9 is being developed by Renibus Therapeutics as an antiviral treatment with organ-protective attributes. The drug, recently awarded fast track designation by the US Food and Drug Administration (FDA) reportedly has demonstrated antiviral properties as well as immune-modulating activities in preclinical studies.
At the onset of the COVID-19 pandemic, Renibus Therapeutics reportedly worked quickly to plan and initiate an RVT-9 trial for COVID-19 patients. According to Cascade Chemistry, Renibus chose its production partner based on experience, flexibility and service focus.
Alvaro Guillem, CEO of Renibus Therapeutics, said Cascade Chemistry offered the knowledge and capabilities necessary to orchestrate and implement an effective strategy.
“Cascade’s ability to move quickly to design, implement, and scale-up a comprehensive RBT-9 API manufacturing strategy has been one of the essential elements in our campaign to initiate clinical trials with minimal delay,” Guillem said. “The professionalism, expertise, flexibility, and client commitment of the Cascade team have facilitated our collaborative effort to advance effective therapies for this devastating global pandemic."
Jeremiah Marsden, Cascade Chemistry president, added that his company was eager for the opportunity to partner with Renibus to produce the necessary API to accelerate RBT-9 into clinical trials for the virus.
“Our reputation as a reliable, experienced, and flexible outsourcing partner with exceptional chemistry problem-solving expertise is based on our many past successes with Renibus and other clients. These qualities are serving us well as we work to complete this important project with impeccable quality and all possible speed,” Marsden said.