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

Patient-Reported Outcomes of Debio 4126, A First 12-Week Formulation of Octreotide in Acromegaly Patients: Results from the OXTEND-01 Trial (ENDO 2026) - "Background: OXTEND-01, a Phase 1b, open label, multicenter trial in patients with controlled acromegaly was conducted to characterize pharmacokinetics, pharmacodynamics, safety, and tolerability of Debio 4126, a novel long-acting octreotide formulation administered intramuscularly every 12 weeks. Debio 4126, administered every 12 weeks maintained biochemical control of acromegaly throughout treatment in the majority of the participants and showed favourable safety and tolerability profiles, similar to SoC. Patients reported numerical improvements in QoL, treatment convenience and satisfaction with Debio 4126 vs SoC."

Clinical • Patient reported outcomes • Acromegaly • Endocrine Disorders • IGF1

What Is the Future of Acromegaly Therapy? (PubMed, J Clin Endocrinol Metab) - "Octreotide subcutaneous depot (CAM2029) maintains biochemical control with acceptable safety and may reduce treatment burden...Collectively, these agents may address unmet needs by broadening the scope of options to control production of hepatic insulin-like growth factor I (IGF-I) and to attenuate additional extrahepatic GH signaling. They may also help ease the practical burden of chronic therapy."

Journal • Acromegaly • Endocrine Disorders • IGF1 • SSTR

Developments in Pharmacotherapy for Acromegaly: Current and Emerging Approaches. (PubMed, Drugs) - "Medical therapies in current use for acromegaly are somatostatin receptor ligands (SRLs) (octreotide long-acting release [LAR], octreotide acetate, lanreotide depot, octreotide subcutaneous (SC) depot, pasireotide LAR, oral octreotide, paltusotine), dopamine agonists (cabergoline) and growth hormone receptor antagonists (pegvisomant)...Several investigational drugs are in development towards addressing unmet needs of patients with acromegaly, including new formulations of SRLs (lanreotide prolonged-release formulation, Debio 4126, pasireotide SC depot), novel SRLs (somatoprim, HTL0030310), monoclonal antibodies against growth hormone, and new growth hormone receptor antagonists. Current and emerging therapies are offering renewed hope for disease control. More studies including comparator agents, identification of accurate biomarkers and models predictive of clinical effectiveness may further improve the care of patients with acromegaly."

Journal • Review • Acromegaly • Endocrine Disorders • SSTR

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