BioChaperone® Lispro (BC Lispro) is a novel ultra-rapid prandial insulin formulation containing insulin lispro and Adocia proprietary technology BioChaperone®. The BioChaperone® excipient ensures a faster absorption of insulin and enables a more effective management of blood glucose levels.
BC Lispro competitive advantages are:
- Better efficacy profile for less hyperglycemia and less hypoglycemia (“Faster-in” / “Faster-out”)
- Good tolerance for optimized daily use
- Range of strengths (U100 & U200), adapted to pump miniaturization and patients’ requirements
BC Lispro is already partnered in Asia with Chinese company Tonghua Dongbao. Phase 3 clinical trials are ongoing in China. Adocia retains development rights for BC Lispro in many territories such as (but not limited to): USA, Europe, Japan and Latin America. BC Lispro is Phase 3 ready for out-licensing in these territories.
Ultra-rapid insulin for more physiologic action
In a person not affected by diabetes, insulin secretion is immediate and proportionate to the meal, to limit glycemic excursion and its long-term effects. To mimic this “physiologic” action profile, injected prandial insulins should ideally start acting very rapidly and for a duration limited to a few hours.
To respond to this need, Adocia has developed two ultra-rapid insulin lispro formulations: BioChaperone® Lispro U100 (standard insulin concentration: 100 Insulin Units/mL) and BioChaperone® Lispro U200 (twice as concentrated solution, i.e., 200 IU/mL). These two prandial insulins offer a significant medical benefit to all users of prandial insulin allowing mealtime injection. A mealtime injection, or right-after-mealtime, enables patients to better determine the appropriate insulin dose in consideration with the exact contents of their meal. This would avoid overdosing or delayed dosing, which can lead to hypo- or hyperglycemia respectively, which both have severe short and long-term consequences. It gives patients some flexibility in terms of time of injection, which is important in day-to-day life.
Finally, ultra-rapid insulins are considered a key element to facilitate the development of fully automated insulin pumps (also called ‘closed-loop system’) that deliver insulin automatically, in real time, depending on continuous monitoring of the patient’s blood glucose levels.
Extensive clinical results based on more than 10 years of development
To date, BioChaperone® Lispro has been successfully tested in 10 clinical studies, in more than 380 people (healthy subjects, type 1 and type 2 diabetes people) and is currently in Phase 3.
- BioChaperone® Lispro has repeatedly shown an ultra-rapid profile compared to reference insulin analogs aspart (Novolog/NovoRapid®, Novo Nordisk) and lispro (Humalog®, Eli Lilly), whereas it was injected via syringes or insulin pumps.
- BC Lispro has also demonstrated superiority on some pharmacodynamic and pharmacokinetic parameters over ultra-rapid insulin Fiasp® (Novo Nordisk).
Phase 2a clinical results – Study of the response to a standardized meal in people with type 1 diabetes (n=38)
Comparison of the effect on postprandial glycemia of BioChaperone® Lispro U100 vs. Humalog® U100 in 38 people with type 1 diabetes. Glycemia is measured for six hours after injecting the treatment at the time of consuming a standardized liquid meal.
Two major partnerships reinforcing the value of BioChaperone Lispro
BioChaperone Lispro program was licensed on two different occasions to the American company Eli Lilly, in 2011 and 2014. During the term of the partnership, Eli Lilly and Adocia successfully completed 6 clinical studies on BioChaperone Lispro U100 and U200. In 2017, Lilly announced its decision to terminate this agreement to prioritize an internal project, LY900014 (Lyumjev®).
Clinical results generated through this key partnership for BioChaperone Lispro development enabled Adocia to enter into a strategic alliance with Chinese company Tonghua Dongbao in 2018. Adocia granted exclusive development and commercialization rights to Tonghua Dongbao for BioChaperone Lispro in China and other Asian and Middle Eastern countries. Under this agreement, Adocia remains responsible for the development and the manufacturing of BioChaperone® pharmaceutical excipient. BioChaperone Lispro Phase 3 program is ongoing in China.