BioChaperone lispro (ultra fast-acting insulin analog) / Adocia, Tonghua Dongbao - LARVOL DELTA

Comparative PK/PD of Single-Dose THDB0206 at Different Injection Sites (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

New P1 trial

BioChaperone Lispro – partnership with Tonghua Dongbao (Businesswire) - "Partner Tonghua Dongbao initiated two Phase 3 studies with Ultra-Rapid Insulin BioChaperone Lispro in 509 Type 1 and 978 Type 2 Diabetes people in 2022. The final dosing of the last Type 2 Diabetes patient was announced on December 12, 20243, triggering a $10 million payment to be received by Adocia at the end of Q2 2025. The last patient dosed in the Type 1 Diabetes study took place in January 2025, leading to the expected announcement of top-line results in mid-2025. Assuming successful Phase 3 results, Tonghua Dongbao plans on submitting Ultra-Rapid Insulin BioChaperone Lispro for Chinese regulatory review in 2025. The granting of Marketing Authorization would lead to an additional milestone payment of $20 million and double-digit royalties on sales to Adocia."

China filing • Commercial • P3 data: top line • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

A Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of THDB0206 Injection in Healthy Chinese Subjects (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

New P1 trial

Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 2 Diabetes (clinicaltrials.gov) - P3 | N=805 | Recruiting | Sponsor: Tonghua Dongbao Pharmaceutical Co.,Ltd

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

One-hundred year evolution of prandial insulin preparations: From animal pancreas extracts to rapid-acting analogs. (PubMed, Metabolism) - "The first rapid-acting analog was lispro (in 1996), soon followed by aspart and glulisine. Recently, even faster analogs have become available (faster aspart, ultra-rapid lispro) or are being studied (Biochaperone lispro), making additional gains in lowering PP-PG. Rapid-acting analogs are recommended in all those with type 1 and type 2 diabetes who need prandial insulin replacement."

Journal • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Are newer insulin analogues better for people with Type 1 diabetes? (PubMed, Diabet Med) - "In the present review we discuss the currently available insulin analogues and the challenges of achieving glucose control using current analogues in those on multiple daily injections, and appraise the evidence base for newer-generation insulin analogues, such as insulin degludec, glargine U300, faster-acting insulin aspart and BioChaperone lispro. We also highlight new insulins in development and unmet needs in people with Type 1 diabetes."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Adocia; Recruiting ➔ Completed

Clinical • Trial completion • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

BioChaperone Lispro (BCLIS) vs faster aspart (FIA) and insulin aspart (ASP) in patients with type 1 diabetes on continuous subcutaneous insulin infusion: a randomized euglycemic clamp study. (PubMed, Diabetes Obes Metab) - "BCLIS also demonstrated significantly higher early exposure (AUCins,0-60min) and lower late exposure (AUCins,120-600min) than both other insulins. In patients with type 1 diabetes using an insulin pump, BCLIS better mimics prandial insulin secretion and action than ASP and shows a faster off-PD than FIA."

Clinical • Journal • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Adocia

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

The continuing quest for better subcutaneously administered prandial insulins: a review of recent developments and potential clinical implications. (PubMed, Diabetes Obes Metab) - "Insulins lispro, aspart and glulisine all achieved an earlier onset of action, a greater peak effect, and shorter duration of action resulting in lower PPG levels and a reduced risk of late post-prandial hypoglycaemia...Recent reformulations of aspart and lispro have generated a second generation of more rapid-acting insulin analogue candidates including fast-acting aspart (faster aspart), ultra-rapid lispro and BioChaperone lispro...Phase 1 trials for BioChaperone lispro are equally encouraging with Phase 3 trials yet to be initiated. Comparative analysis of the clinical and pharmacological evidence for these new prandial insulin candidates in the treatment of type 1 and type 2 diabetes, is the main focus of this review."

Clinical • Journal • Review

"relevant for $ADOC --> for BC Lispro (in EU/US): fiasp sales ~94m$ in 2018 WW (+500%) --> for BC Combo (in EU/US): Ryzodeg sales ~112m$ in 2018 WW (+45%)" (@BiotechRadar)

Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas (clinicaltrials.gov) - P=N/A; N=20; Not yet recruiting; Sponsor: Massachusetts General Hospital; Trial completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date