Cascade Chemistry, a contract research and manufacturing organisation serving the pharmaceutical, materials, and chemical industries, has been selected to produce the active pharmaceutical ingredient (API) for clinical trial supplies of RBT-9, an investigational therapy 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 US FDA, has demonstrated both antiviral and immune-modulating activities in preclinical studies.
RBT-9 is being developed by Renibus Therapeutics as an antiviral 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 Cascade Chemistry as the company with the experience, flexibility, and client focus to rapidly supply the clinical materials needed to field the RBT-9 COVID-19 trial in a timely way.
"We welcomed the opportunity to join forces with Renibus to produce the API needed to speed RBT- 9 into clinical trials for COVID-19," said Jeremiah Marsden, President of Cascade Chemistry. "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."
Cascade's experience, flexibility, and consistent client focus allowed the company to rapidly:
- Identify and implement a new scalable manufacturing strategy
- Design a focused process R&D programme to remove synthetic bottlenecks and reduce problematic impurities
- Develop and improve analytical testing and methods
- Implement cGMP process controls under tight deadlines
- Achieve aggressive timelines to move from design into manufacturing
Alvaro Guillem, CEO at Renibus Therapeutics, said: "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. 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."
