Biotech clinical news summary, 18 October

Today in brief

Diasome is preparing pivotal trials of HDV-insulin after a Phase IIb study found it non-inferior to insulin lispro for A1C reduction and associated with less clinically meaningful hypoglycemia.1 A medical-record study of more than two million adults linked GLP-1 medication use with lower odds of cardiovascular events and infections after surgery.2

Diasome advances HDV-insulin toward Phase III

Diasome is completing protocol and statistical plans for pivotal trials of HDV-insulin in type 1 diabetes after its 226-person Phase IIb OPTI-2 trial found the treatment non-inferior to insulin lispro for A1C reduction.1 The trial also linked HDV-insulin to less clinically meaningful hypoglycemia while maintaining glycemic control.1

CEO Robert Geho said the company intends to discuss the program with the FDA.1

GLP-1 use linked to lower postsurgical risks

In an analysis of more than two million adults who had surgery, GLP-1 medication use was associated with 11% lower adjusted odds of major cardiovascular events and 8% lower adjusted odds of postoperative infections.2 The medical-record study found associations, not proof of cause, and did not determine whether stopping treatment before surgery affected outcomes.2

Also worth knowing

P
Novartis abandoned a trial of Fabhalta in lupus nephritis.3