Debio 4126, a new 3-month octreotide formulation, provides sustained release of octreotide, as well as enhanced bioavailability and similar suppression of insulin-like growth factor 1 (IGF-1), compared to monthly Sandostatin LAR® in healthy volunteers – interim results

Presented at ENEA 2022 – 20th Congress of the European NeuroEndocrine Association

A.Bellon^a , J.Klein^b , D.Spaggiari^a , M.Marquardt^a , F. Frérart^c , D. Rechavi-Robinson^a , A. Marguerettaz^d , B. Plagès^d , L.Merinat^a , C. Beden^a , B. Ducrey^a , B.Gavillet^a , L.Tauchmanova^a

^a Debiopharm, Lausanne, SWITERLAND
^b SGS Belgium – Health & Nutrision, Edegem, BELGIUM
^c SGS Belgium – Health & Nutrision, Mechelen, BELGIUM
^d Debiopharm Research & Manufacturing, Martigny, SWITERLAND

Introduction

Debio 4126-101 trial is an open-label, active-controlled, parallel-group, single site Phase 1 study in healthy volunteers with flexible design. The aim is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety and tolerability of a single administration IM or SC of two formulations in two solvents of a 3-month sustained-release octreotide formulation, Debio 4126.​