octreotide 3-month extended release (Debio 4126) / Debiopharm - LARVOL DELTA

OXTEND™-03: A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs (clinicaltrials.gov) - P3 | N=119 | Recruiting | Sponsor: Debiopharm International SA | Not yet recruiting ➔ Recruiting

Enrollment open • Acromegaly • Endocrine Disorders • IGF1

OXTEND™-03: A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs (clinicaltrials.gov) - P3 | N=119 | Not yet recruiting | Sponsor: Debiopharm International SA

New P3 trial • Acromegaly • Endocrine Disorders • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: Debiopharm International SA | Active, not recruiting ➔ Terminated; The recruitment was halted for strategic reasons

Trial termination • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1 | N=20 | Active, not recruiting | Sponsor: Debiopharm International SA | N=30 ➔ 20

Enrollment change • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Debiopharm International SA | Recruiting ➔ Active, not recruiting | Phase classification: P1b ➔ P1 | Trial completion date: Jun 2025 ➔ Dec 2024

Enrollment closed • Phase classification • Trial completion date • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Feb 2025 ➔ Jun 2025 | Trial primary completion date: Jan 2025 ➔ May 2025

Trial completion date • Trial primary completion date • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

DEBIOPHARM APPLIES EXTENDED-RELEASE FORMULATION EXPERTISE TO REDUCE TREATMENT FREQUENCY BURDEN FOR ACROMEGALY & GEP-NET PATIENTS (Canada Newswire) - "Debiopharm...announced that the first patient was dosed with Debio 4126, a 3-month extended-release formulation of octreotide, in their open-label, non-randomized, single-arm, multicenter phase 1b study (Debio 4126-102). The study is composed of two patient cohorts – 1 group of patients with acromegaly and 1 group with functioning GEP-NETs Patients will receive 4 injections of Debio 4126 for a total treatment duration of 48 weeks."

Trial status • Acromegaly • Neuroendocrine Tumor • Oncology • Solid Tumor

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 (ENEA 2022) - "Bioavailability appeared higher after Debio 4126 administration. Debio 4126 provides sustained release of octreotide over the dosing interval of 12 weeks at a level considered adequate for treatment of patients with acromegaly."

Clinical • Acromegaly • Endocrine Disorders • Gastroenterology • Gastrointestinal Disorder • Hepatology • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Debiopharm International SA | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jun 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1b | N=30 | Recruiting | Sponsor: Debiopharm International SA | Not yet recruiting ➔ Recruiting

Enrollment open • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1b | N=30 | Not yet recruiting | Sponsor: Debiopharm International SA | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion date • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1

OXTEND-01: A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) (clinicaltrials.gov) - P1b | N=30 | Not yet recruiting | Sponsor: Debiopharm International SA

New P1 trial • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • IGF1