Memorandum

Adocia expands R&D into obesity with BioChaperone Glucagon Exenatide; Preclinical studies underway – January 19, 2018

Executive Highlights

  • Early this month, Adocia announced that it will expand its BioChaperone program into obesity with a glucagon/exenatide fixed-ratio combination (and into short bowel syndrome with GLP-2 agonist teduglutide).
  • BioChaperone Glucagon Exenatide joins a robust competitive landscape of dual peptide agonists, many of which are being investigated toward an obesity indication (Sanofi, Novo Nordisk, OPKO Health). Click here for our GLP-1/glucagon dual agonist competitive landscape.

Adocia began 2018 with an update to its corporate strategy, including a new R&D focus on obesity. The company has initiated preclinical studies of BioChaperone glucagon/exenatide fixed-ratio combination for obesity.

This news comes on the heels of positive topline results from a phase 1 study of BioChaperone Glucagon (demonstrating safety, tolerability, and hypoglycemia rescue in ~11 minutes). Adocia’s announcement cites increased energy expenditure and weight loss with glucagon/GLP-1 dual agonists, and indeed, BioChaperone glucagon/exenatide joins a robust competitive landscape of these dual peptide therapies.

Sanofi will launch phase 3 studies of its glucagon/GLP-1 candidate in obesity this year (likely 2H18). OPKO Health is also targeting an obesity indication for its phase 2 glucagon/GLP-1 dual agonist. Novo Nordisk has a glucagon/GLP-1 dual agonist and a glucagon/GLP-1/GIP tri-agonist in phase 1 for obesity. It’s certainly noteworthy that major industry players are excited by the scientific promise of dual peptide approaches to obesity (as well as type 2 diabetes and NASH).

Moreover, Adocia’s plans for BioChaperone Glucagon Exenatide fit with a recent trend we’ve noticed of diabetes companies expanding R&D into adjacent indications, particularly obesity and NASH. The under-diagnosis and under-treatment of obesity makes for high market potential, provided these companies are also able to promote an understanding of obesity as a medical condition. Enhancing reimbursement for obesity drugs will also be key, although this is some ways away for Adocia and preclinical BioChaperone Glucagon Exenatide.

No timing was shared for projected completion of preclinical investigations. The company also launched a preclinical program of GLP-2 agonist teduglutide for short bowel syndrome.

Other BioChaperone Projects

  • BioChaperone technology has proven useful in accelerating action of prandial insulin, where fast onset/offset are critically important. Adocia’s BioChaperone Lispro is its most advanced candidate (phase 3-ready). The company announced positive topline data from a phase 2 head-to-head trial vs. Novo Nordisk’s Fiasp (faster-acting insulin aspart) and NovoLog (insulin aspart) late last year; full results are expected at a major scientific meeting this year. Progress for BioChaperone Lispro stalled somewhat after Lilly terminated its licensing agreement in January 2017, and Adocia has been seeking another dedicated clinical partner before initiating phase 3. That said, management told us recently that a go-alone pathway is not off the table. Adocia plans to meet with FDA in 2018 to discuss the phase 3 program.
  • The platform enables stable glucagon, so that it could be prescribed as a ready-to-inject liquid. In contrast, current options for glucagon rescue therapy require a lengthy and error-prone reconstitution process. BioChaperone Glucagon recently completed a phase 1 study, and topline results were positive in people with type 1 diabetes. See our competitive landscape of next-gen glucagons for an overview of products in development. Zealand and Xeris have candidates in phase 3, while Lilly plans to file its nasal glucagon with FDA this year.
  • The BioChaperone platform also allows for novel combinations of molecules, such as insulin glargine + insulin lispro and glucagon + exenatide. In treating obesity, we imagine more even onset/offset – to cover patients for 24 hours – is preferable, and we’re interested to see what advantages Adocia’s delivery system might provide.

 

-- by Ann Carracher, Payal Marathe, and Kelly Close