Adocia announced the dosing of the first patient with the BioChaperone® Lispro (“BC Lispro”) Phase 3 study. BC Lispro belongs to the last generation of Ultra-Rapid Insulins together with Fiasp® (Novo Nordisk®) and Lyumjev® (Eli Lilly®). The Phase 3 program consists of 2 studies treating people with type 1 and type 2 diabetes in 100 clinical centers across China and will enroll a total of c. 1300 patients. The aim of this program is to demonstrate safety and efficacy in comparison to standard of care (Humalog®). Results of this program will then be submitted to the Chinese Regulatory Authorities by Tonghua Dongbao to obtain marketing authorization. BC Lispro has been licensed-out to Tonghua Dongbao for China and major territories in Western Pacific and South-East Asia Regions that represents 200 million people suffering from diabetes1 and an estimated 20 million are using insulin every day for their survival.
In 2018, the Chinese insulin market represented more than $3.5 billion2 and is forecasted to reach $5 billion2 in 2025 due to increased access to medicine, diagnosis, and prevalence of diabetes. BioChaperone® (BC) Lispro is an Ultra-Rapid Insulin obtained by combining Adocia's proprietary BioChaperone technology to the rapid-acting market leader insulin lispro (as contained in the commercial product Humalog®). Being distributed more rapidly into the bloodstream than previous generations of insulins, BC Lispro reduces after-meal hyperglycemic excursions that are responsible for long-term comorbidities such as retinopathy, diabetic foot ulcer, kidney failure. Moreover, being eliminated faster from the body, BC Lispro may also reduce the risk of hypoglycemic events that are caused when insulin remains too long in the bloodstream after the post-meal hyperglycemia peak has declined. On top of its direct clinical benefits, the onset of action of BC Lispro results in improved quality of life with more dose-timing flexibility at mealtime. A mealtime injection, or even right-after-mealtime, enables patients to better determine the appropriate insulin dose as the exact timing and contents of their meal is known. This avoids overdosing or delayed dosing, which can lead to hypo- or hyperglycemia respectively, and prevent their severe short and long-term consequences. It significantly reduces the stress and the mental load of those affected by insulin-dependent diabetes and their caretakers which is important in day-to-day life. Currently, the only drugs providing similar effects in the world are Fiasp® of Novo Nordisk Co. and Lyumjev® of Eli Lilly and Company. Fiasp® and Lyumjev® are not currently available in China. BC Lispro was licensed to Tonghua Dongbao in 2018 in exchange for a $10 million upfront fee. The agreement also includes maximum payments of $35 million subjects to the achievement of future development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao. BC Lispro is patent protected until 2033.