“This is very good example of a trend in the industry where pharma companies with promising profiles partner with CROs that can offer a comprehensive range of R&D services,” Christian Weyer, MD, Profil Institute President and Chief Development Officer, told Outsourcing-Pharma.com.
According to Weyer, the company’s experience has led it to a point where it “can engage in broader strategic partnerships with clients, such as HighTide, to enable them to advance their pipeline.”
Per the agreement, announced July 28, 2016, Profil Institute will provide clinical research and development services for HighTide's drug candidate portfolio – from IND readiness through early phase development, including regulatory and scientific support services.
Weyer told us the increase in demand for diabetes and NAFLD/NASH (non-alcoholic fatty liver disease and non-alcoholic steatohepatitis) products is being driven by “a concerning pandemic” of obesity and type 2 diabetes, which is “threatening the global healthcare system.”
“We are seeing a robust early pipeline in not just type 2, but increasingly in type 1, and certainly in the NAFLD/NASH space,” added Weyer.
While there are still relatively few treatment options for NAFLD/NASH, Weyer said there has been some successes in the recent years, and that he has seen “a promising increase in the number of targets and the number of companies now pursuing that regulatory path.”
He added, “We think that there is a considerable opportunity for this field to develop substantially.”
Profil Institute has already provided Ph I support for HighTide’s islet regeneration peptide HTD4010, which is expected to enter phase II clinical trials in early 2017.