Adocia Announces First Half 2021 Financial Results and Provides an Update on Activities - Seite 3

“Adocia is pursuing an intense clinical program on prandial combinations while preparing a new wave of innovation on cell therapy and obesity. The cash position is sufficient to fund these programs but it pushes the company to maintain a strict budget management and to prioritize our expenses”, comments Valérie Danaguezian, Adocia’s Chief Financial Officer.

Half-year key events and perspectives for 2021

The first half of 2021 was marked by significant advances in our insulin pipeline, and by the initiation of new projects in cell therapy and obesity treatment.

Significant progress was made at every maturity level of our pipeline.

• BioChaperone Lispro to enter Phase 3 in China

The Phase 3 application for the ultra-rapid insulin BC Lispro has been filed with the Chinese regulatory authorities by our partner Tonghua Dongbao. The response is expected in the third quarter of 2021. The start of the Phase 3 in China would trigger a milestone payment to Adocia. In parallel, the preparatory work for the Phase 3 studies in the United States and Europe has been successfully completed and our commercial activities are aimed at finding a partner capable of financing the pivotal program through marketing authorization for these territories.

• M1Pram and BioChaperone LisPram: first-in-class combinations with high added value

Adocia has intensified the clinical development of its two candidates, M1Pram and BC LisPram, positioned respectively for the auto-injector and pump markets. These fixed-dose combinations of insulin and amylin analogs are intended to replace rapid-acting insulins, which are essential to the survival of many patients, and which generate more than $9 billion in revenues each year. These combinations are intended to improve glycemic control, while triggering weight loss in obese diabetic patients. In the United States, 65% of type 1 and 85% of type 2 diabetic patients are overweight or obese^2,3.

A Phase 2 study (CT041) has been initiated with M1Pram in auto-injector. This follows the establishment of the human proof of concept, the results of which were communicated in September 2020 (CT038 - part B). M1Pram had demonstrated, in just 3 weeks of treatment, an improvement in glycemic control and a very significant weight loss, compared to the reference rapid insulin aspart. The CT041 Phase 2 study, which aims to confirm these results over a 4-month period in patients with type 1 diabetes, has been designed to define all the parameters of the future Phase 3 program. Results are expected in the first half of 2022.