BIOCHAPERONE® GLARGINE GLP-1
BIOCHAPERONE® GLARGINE GLP-1 : simple intensification options over basal insulin
Basal insulin remains an essential treatment for patients with type 2 diabetes who do not reach glycemic targets on oral antidiabetic agents. However, by some estimates, up to 50% of people with diabetes who use basal insulin as their only injectable treatment do not reach their glycemic target1.
As the underlying mechanisms of action of basal insulin and GLP-1 receptor agonists (“GLP-1s”) are complementary, combinations of the two agents have been developed as one product, once-daily treatment intensification options for these patients. In Phase 3 clinical studies, such combinations have demonstrated improved glycemic control while reducing side effects compared to each agent used separately (similar or less hypoglycemic events than insulin alone and less gastrointestinal side effects than GLP-1 alone)2. Two basal insulin-GLP-1 combinations have been filed for approval with the FDA, who is expected to reply by the end of 2016.
TWO POTENTIAL CANDIDATES
In September 2016, Adocia announced a new preclinical BioChaperone program combining basal insulin with GLP-1s. This new program, based on Adocia’s expertise in solubilizing insulin glargine at physiological pH, features two candidate products: BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide.
BioChaperone technology solubilizes and stabilizes insulin glargine in aqueous solution at physiologic pH. This change in the solubility profile of glargine enables its combination with proteins only stable at neutral pH, such as the two market-leaders GLP-1s of interest to Adocia, liraglutide (Victoza®, Novo Nordisk) and dulaglutide (Trulicity®, Eli Lilly). This formulation strategy, built on the efficacy and safety records of already approved molecules, could shorten development time and offer lower risk compared to the development of new molecular entities.
- BioChaperone Glargine Liraglutide is a once-daily product candidate based on insulin glargine and GLP-1 gold-standard liraglutide (Victoza®, Novo Nordisk). This combination based on two products whose patents are close to expiry (2015 & 2023, respectively) is an opportunity for Adocia to develop a proprietary candidate with a potential cost-advantage to competitors.
- BioChaperone Glargine Dulaglutide is a once-daily product candidate based on insulin glargine and dulaglutide (Trulicity®, Eli Lilly). Using the once-weekly GLP-1 dulaglutide in a once-daily formulation may flatten its pharmacodynamic profile and maximize its efficacy.
The BioChaperone Glargine GLP-1 program is currently in preclinical development. Based on synergies with Adocia BioChaperone Combo program, a first clinical study on a lead product could be initiated in 2017.
1 Sanofi, Corporate presentation Q3 2015
2 Results from the LixiLan-L & Lixilan-O Phase 3 trials of LixiLan® (Sanofi, a combination of insulin glargine with lixisenatide) and from the DUAL Phase 3 program of Xultophy® (Novo Nordisk, a combination of insulin degludec and liraglutide) were presented at the 76th Scientific Sessions of ADA (New Orleans, June 10-14, 2016) and EASD 52nd Annual Meeting (Munich, September 12-16, 2016).