Today Diasome Pharmaceuticals announced that it has received an investment of up to $30 million led by Medicxi’s recently announced Growth Fund I, and including support from the JDRF T1D Fund, Black Beret Life Sciences, and McDonald Partners. This investment will support the development of Diasome’s Hepatocyte Directed Vesicle (HDV) technology, which consists of nano-vesicles added to insulin lispro to target the insulin to the liver, thus enhancing its onset of action. Previously Diasome has received support from the Joslin Diabetes Center and has entered a partnership with the patient-entrepreneur incubator Lyfebulb. This new funding from Medicxi and the JDRF T1D Fund, a venture philanthropy fund with the goal of accelerating research into the treatment, prevention, and cure of type 1 diabetes, will support three phase 2 trials studying the delivery of HDV lispro in people with type 1 diabetes. At the GTC Bio Diabetes Summit this April, Mr. Robert Geho, the CEO of Diasome, elaborated on these trials. The six-month phase 2b ISLE-1 study, initiated in 2Q16 in partnership with Joslin, randomizes 150 patients with type 1 diabetes on MDI to either HDV insulin lispro or unaltered insulin lispro on top of basal insulin using blinded CGM and is expected to report topline results by the end of the year. In addition, two new phase 2 studies – one in relatively well-controlled patients with type 1 diabetes on MDI and one in insulin pump users – have initiated this quarter. (See our coverage of Diasome for more detail on the study designs). As a reminder, the history of hepatic-targeted insulins is complicated –Lilly’s liver-targeted peglispro was derailed by safety issues (mainly liver toxicity) in 2015. We look forward to eventually hearing from primary investigators in these trials – Dr. Bruce Bode, Dr. Satish Garg, and Dr. David Klonoff – regarding Diasome’s HDV technology. Notably, the ISLE-1 trial involves monitoring with liver MRIs as an additional safety consideration, a measure which we hope will provide conclusive answers on the issue of liver toxicity. We eagerly await the results of these three trials – all expected this year – as faster, safe insulin could help patients achieve better control of their diabetes.
-- by Ann Carracher, Abigail Dove, and Kelly Close