SAN DIEGO--(BUSINESS WIRE)--LATITUDE Pharmaceuticals, Inc. (LPI) announced today that its scientists have developed the first ever, ready-to-inject, stable liquid glucagon formulation (Nano-G). A glucagon formulation with these properties had been a highly sought after Holy Grail of drug developers for decades.
Currently, glucagon is indicated for emergency treatment of insulin-induced hypoglycemia and as a diagnostic aid for radiological examinations. Researchers have long been interested in evaluating glucagon for hypoglycemia prevention, the bi-hormonal insulin/glucagon pump and the treatment of obesity but have been thwarted by the absence of a stable injectable glucagon formulation.
Glucagon is a notoriously insoluble and unstable molecule and is therefore provided as a dried powder. Before use, the glucagon is dissolved in an acid solution by following a cumbersome, eight-step procedure that becomes an outsized task during life-threatening hypoglycemia.
Nano-G is a pH-neutral, isotonic, detergent-free, aqueous formulation that contains only FDA-approved injectable ingredients. Results from rigorous 6-month real-time and accelerated ICH stability testing predict a 2-yr shelf-life. Nano-G is also stable at body temperature, making it highly suitable for subcutaneous infusion pump delivery.
“Nano-G fulfills the long overdue need for a rapidly self-administered, auto-injector delivered glucagon for hypoglycemia rescue and is the missing piece needed for the bi-hormonal pump and novel combination therapies for obesity,” noted Dr. Andrew Chen, LPI’s president. “With its excellent stability and regulatory familiarity, Nano-G can be rapidly commercialized under a low risk, low-cost 505(b)(2) NDA to provide important new therapeutic options for diabetes and obesity that were never before possible. We are now seeking partners to commercialize this exceptional multi billion dollar opportunity.”
Nano-G is based on LPI’s Nano-E injectable nanoemulsion drug delivery platform. Nano-E has a proven capability for solubilizing and stabilizing highly insoluble compounds and is the formulation technology behind two 505(b)(2) NDA-stage injectable drugs and other preclinical and clinical programs.
LPI is a leading drug formulation development group that incorporates innovative and leading-edge approaches into its client projects and into its own reformulation programs. The company is recognized for its success with highly insoluble drugs and for developing inventive approaches and intellectual property for its clients. LPI’s internal programs focus on developing outlicense-ready 505(b)(2) NDA opportunities.