Abstract Search

ea0073oc15.4 | Oral Communications 15: Late Breaking | ECE2021

Identification of a dose range for once daily oral paltusotine in patients with acromegaly that maintains IGF-1 levels when switching from long-acting somatostatin receptor ligand therapy

Gordon Murray B. , Gadelha Monica , Toth Miklos , Doknic Mirjana , Mezosi Emese , Randeva Harpal , Marmon Tonya , Luo Rosa , Monahan Michael , Madan Ajay , Struthers Scott , Krasner Alan

Long-acting somatostatin receptor ligands (LA-SRLs) are a first line medical treatment for acromegaly but require monthly parenteral administration. Paltusotine (CRN00808) is a nonpeptide, small molecule somatostatin type 2 (SST2) receptor agonist with high oral bioavailability (70%), suitable for once daily, oral dosing. The recently reported results of the ACROBAT Edge study (NCT03789656) suggest that patients with acromegaly treated with injected SRLs can switch to once dai...

ea0077p80 | Neuroendocrinology and Pituitary | SFEBES2021

ACROBAT Advance: progress report on a study of long-term safety and efficacy of paltusotine for the treatment of acromegaly

Randeva Harpal , R . Gadelha Monica , Gordon Murray B. , Mezosi Emese , Doknic Mirjana , Toth Miklos , Boguszewski Cesar , Jochelson Theresa , Nichols Melissa , Luo Rosa , Madan Ajay , Ferrara-Cook Christine , Krasner Alan , Casagrande Alessandra , Scott Struthers R.

Paltusotine is a once-daily, oral selective nonpeptide somatostatin receptor type 2 (SST2) agonist, which is in clinical development for the treatment of acromegaly. Maintenance of insulin-like growth factor 1 (IGF-1) control and toleration was demonstrated in phase 2 studies evaluating paltusotine in biochemically controlled (IGF-1 ≤1xULN) [ACROBAT Evolve (NCT03792555)] and uncontrolled (1> IGF-1 ≤2.5xULN) [ACROBAT Edge (NCT03789656)] patients with acromegaly ...

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ea0081oc4.6 | Oral Communications 4: Pituitary and Neuroendocrinology 1 | ECE2022

ACROBAT advance: once daily, oral paltusotine treatment maintained long-term igf-1 at levels previously achieved with injectable long-acting somatostatin receptor ligands (LA-SRLs)

Gadelha Monica R , Randeva Harpal , Gordon Murray B , Mezosi Emese , Doknic Mirjana , Toth Miklos , Boguszewski Cesar L , Nichols Melissa , Jochelson Theresa , Henley Scott , Patel Meenal , Mendez Debbie Koh , Ferrara-Cook Christine , Krasner Alan , Casagrande Alessandra , Struthers R Scott

Paltusotine is a once-daily, oral, nonpeptide somatostatin receptor type 2 (SST2) specific agonist, in development for the treatment of acromegaly and neuroendocrine tumors. We report interim results from ACROBAT Advance (NCT04261712), an ongoing, multicenter, open-label, long-term extension study of paltusotine in subjects with acromegaly who previously completed either Phase 2 study ACROBAT Edge (NCT03789656) or Evolve (NCT03792555). ACROBAT Edge enrolled 47 subjects with el...

ea0073oc13.6 | Oral Communications 13: Pituitary and Neuroendocrinology | ECE2021

A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands

Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Grineva Elena , Poteshkin Yury E. , Gilgun-Sherki Yossi G , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Biermasz Nienke , Melmed Shlomo K. , Strasburger Yossi G

BackgroundMPOWERED, a large phase 3 trial, assessed maintenance of response to oral octreotide capsules (OOC; MYCAPSSA) compared to injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly who responded to OOC and iSRLs (octreotide or lanreotide). OOC were recently approved in the US for patients with acromegaly who responded to and tolerated iSRLs.MethodsEligibility criteria included age ...

ea0073pep3.2 | Presented ePosters 3: Pituitary and Neuroendocrinology | ECE2021

Safety results from MPOWERED, a phase 3 trial of oral octreotide capsules in adults with acromegaly

Freda Pamela U. , Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Huang Wenyu , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Biermasz Nienke , Melmed Shlomo K. , Strasburger Christian J.

BackgroundInjectable somatostatin receptor ligands (iSRLs) have been a mainstay in acromegaly treatment. Oral octreotide capsules (OOC; MYCAPSSA®) were recently approved in the USA. Results from the placebo-controlled CHIASMA OPTIMAL and open-label CH-ACM-01 studies showed an OOC safety profile consistent with that of iSRLs with no new or unexpected safety signals. Results of the MPOWERED trial have enabled a comparison of OOC safety and ...

ea0073pep8.1 | Presented ePosters 8: Pituitary and Neuroendocrinology | ECE2021

Oral octreotide capsules lowered incidence and improved severity of acromegaly symptoms compared to injectable somatostatin receptor ligands—results from the MPOWERED trial

Biermasz Nienke , Fleseriu Maria , Dreval Alexander V , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E , Macut Djuro P , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H , Patou Gary , Haviv Asi , Gordon Murray B , Urbanavicius Vaidotas , Knispelis Robertas , Melmed Shlomo K , Strasburger Christian J

BackgroundPatients with acromegaly may have high symptom burden. The phase 3 MPOWERED trial assessed control of acromegaly by oral octreotide capsules (OOC; MYCAPSSA®) in comparison to injectable somatostatin receptor ligands (iSRLs) in patients responding to both OOC and iSRLs. iSRLs have been first-line medical treatment for patients with acromegaly for decades. OOC are newly approved in the US for patients previously controlled on iSRL...

ea0073pep8.3 | Presented ePosters 8: Pituitary and Neuroendocrinology | ECE2021

Addition of cabergoline to oral octreotide capsules may improve biochemical control in patients with acromegaly who are inadequately controlled with monotherapy

Fleseriu Maria , Dreval Alexander V. , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E. , Macut Djuro P. , Leonova Nina , Raverot Gerald , Yossi Gilgun-Sherki , Ludlam William H. , Patou Gary , Haviv Asi , Gordon Murray B. , Verbovoy Andrey , Dogadin Sergey A. , Biermasz Nienke , Strasburger Christian J. , Melmed Shlomo K.

BackgroundOral octreotide capsules (OOC; MYCAPSSA®) are approved in the US for individuals with acromegaly who responded to and tolerated treatment with injectable somatostatin receptor ligands (iSRLs). Add-on cabergoline therapy has shown effectiveness in patients previously inadequately controlled with iSRLS.1 The phase 3 MPOWERED trial assessed maintenance of response with OOC compared to iSRLs. Patients receiving OOC and in...

ea0073pep13.6 | Presented ePosters 13: Pituitary and Neuroendocrinology | ECE2021

Improved acromegaly patient satisfaction with oral octreotide capsules compared with injectable somatostatin receptor ligands in the MPOWERED trial

Gordon Murray B , Fleseriu Maria , Dreval Alexander V , Pokramovich Yulia , Bondar Irina , Isaeva Elena , Molitch Mark E , Macut Djuro P , Leonova Nina , Raverot Gerald , Kirschner Lawrence S , Chanson Philippe , Yossi Gilgun-Sherki , Ludlam William H , Patou Gary , Haviv Asi , Biermasz Nienke , Melmed Shlomo K , Christian J Strasburger

BackgroundImproved patient-reported outcomes (PROs) are increasingly becoming a key treatment objective in acromegaly. Validated PROs were used to assess disease and treatment burden in the MPOWERED phase 3 trial in acromegaly, which also assessed safety and efficacy of oral octreotide capsules (OOC; MYCAPSSA®) compared to injectable SRLs (iSRLs).MethodsEligible patients had acromegaly diagnosis, biochem...