ONO-5788 / Ono Pharma - LARVOL DELTA

Investigational drugs for the Treatment of Acromegaly: new agents to transform therapy. (PubMed, Expert Opin Investig Drugs) - "The aim of current review is to provide a detailed update about investigational drugs for acromegaly treatment currently under investigation as paltusotine, ONO-5788, AP102, GT-02037, ISIS 766,720, CAM2024, Lanreotide PRF, DP1038, MTD201, solid dose injection of octreotide. Current studies are addressing patient's needing for both new molecules and less invasive routes of administration for already existing drugs. It cannot be ruled out that drugs currently used for other disease such as cancers could be considered in the future for the treatment of acromegaly."

Journal • Review • Acromegaly • Endocrine Disorders • Oncology

The future of somatostatin receptor ligands in acromegaly. (PubMed, J Clin Endocrinol Metab) - "Currently, first-generation somatostatin receptor ligands (fg-SRLs), octreotide LAR and lanreotide autogel, are the mainstays of acromegaly treatment and achieve biochemical control in approximately 40% of patients and tumor shrinkage in over 60% of patients. New formulations of available SRLs, such as oral, subcutaneous depot and nasal octreotide, may improve patients' adherence to treatment and quality of life since there will be more options available that better suit each patient. Finally, new drugs, such as paltusotine, somatropin, ONO-5788 and ONO-ST-468, may improve treatment adherence and present higher efficacy than currently available drugs."

Journal • Acromegaly • Endocrine Disorders • Oncology • SSTR

ONO-5788-02: Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Ono Pharmaceutical Co. Ltd; Active, not recruiting ➔ Completed; Trial completion date: Oct 2019 ➔ Apr 2019; Trial primary completion date: Oct 2019 ➔ Apr 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

ONO-5788-02: Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Trial completion date: Apr 2019 ➔ Aug 2019; Trial primary completion date: Apr 2019 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date

A Four-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-5788 in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=76; Terminated; Sponsor: Ono Pharmaceutical Co. Ltd; N=136 ➔ 76; Recruiting ➔ Terminated; The study met a pre-defined protocol study stopping criteria

Clinical • Enrollment change • Trial termination

A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, and Pharmacokinetics of ONO-5788: A Novel Oral Small Molecule Somatostatin Receptor Type-2 Agonist (ENDO 2019) - "ONO-5788 was found to be well tolerated in this SAD study at all doses tested. The pharmacokinetic profiles of ONO-5788 and its active metabolite were well characterised with a half-life suggesting the potential for once-daily dosing. Safety, tolerability, pharmacokinetics and pharmacodynamics will continue to be assessed in healthy volunteers with multiple dosing, dosing of a cohort of elderly subjects and a proof-of-principle study to further characterize ONO-5788 prior to studies in patients.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation."

Clinical • P1 data • PK/PD data

ONO-5788, a Novel Oral Small Molecule Somatostatin Receptor Type-2 (SST2) Agonist, Attenuates GH Hypersecretion in Human GH-Secreting, Pituitary Adenoma-Derived Cells (ENDO 2019) - "Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

A Phase 1 Study in Healthy Volunteers to Assess the Safety, Tolerability, and Pharmacokinetics of ONO-5788: A Novel Oral Small Molecule Somatostatin Receptor Type-2 Agonist (ENDO 2019) - "ONO-5788 was found to be well tolerated in this SAD study at all doses tested. The pharmacokinetic profiles of ONO-5788 and its active metabolite were well characterised with a half-life suggesting the potential for once-daily dosing. Safety, tolerability, pharmacokinetics and pharmacodynamics will continue to be assessed in healthy volunteers with multiple dosing, dosing of a cohort of elderly subjects and a proof-of-principle study to further characterize ONO-5788 prior to studies in patients.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation."

Clinical • P1 data • PK/PD data

Non-Clinical Profiling of ONO-5788, a Novel Oral Small Molecule Somatostatin Receptor Type-2 (SST2) Agonist, to Support Studies in Humans (ENDO 2019) - "In experiments evaluating the effects on insulin and glucagon secretion in anaesthetised rats, ONO-5788, ONO-ST1-641, octreotide and pasireotide significantly inhibited glucagon secretion, but ONO-5788 and ONO-ST1-641 had no significant impact on insulin secretion at doses up to 10-fold higher than the dose required for either of these compounds to almost maximally inhibit GH secretion. Orally administered ONO-5788 demonstrates potency as a SST2 agonist and has the potential to be a new treatment option for patients with acromegaly and NET.*Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference."

Clinical

ONO-5788-02: Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788 (clinicaltrials.gov) - P1; N=12; Active, not recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed