SFEBES2021 Poster Presentations Neuroendocrinology and Pituitary (47 abstracts)
ACROBAT Advance: progress report on a study of long-term safety and efficacy of paltusotine for the treatment of acromegaly
Harpal Randeva 1 , Monica R . Gadelha 2 , Murray B. Gordon 3 , Emese Mezosi 4 , Mirjana Doknic 5 , Miklós Tóth 6 , Cesar Boguszewski 7 , Theresa Jochelson 8 , Melissa Nichols 9 , Rosa Luo 9 , Ajay Madan 9 , Christine Ferrara-Cook 9 , Alan Krasner 9 , Alessandra Casagrande 9 & R. Scott Struthers 9
1University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom; 2Neuroendocrinology Research Center/Endocrinology Division--Medical School and Hospital Universitario Clementino Fraga Filho--Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil; 3Allegheny Neuroendocrinology Center, Allegheny General Hospital, Pittsburgh, USA; 4University of Pécs Medical School, 1st Department of Internal Medicine, Pécs, Hungary; 5Clinical Centre Serbia Clinic for Endocrinology, Diabetes and Metabolic Diseases, Belgrade, Serbia; 6Semmelweis University, Department of Internal Medicine and Oncology, Budapest, Hungary; 7SEMPR, Endocrine Division, Department of Internal Medicine, Federal University of Parana, Curitiba, Brazil; 8Rancho Clinical Research Consulting (RCRC), LLC, Rancho Santa Fe, USA; 9Crinetics Pharmaceuticals, San Diego, USA
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 treated with stable long-acting octreotide or lanreotide. Patients in both parent studies were switched to oral paltusotine for up to 13 weeks. We hypothesized that continued paltusotine therapy would result in the long-term maintenance of IGF-1 control with acceptable toleration and safety. Subjects who completed ACROBAT Evolve or Edge were eligible to participate in ACROBAT Advance (NCT04261712), an ongoing single-arm, open-label 208-week extension study. Patients were eligible to enroll into Advance directly upon completion of the parent trial or after a gap period on standard of care treatment. In Advance, all subjects initiate 10 mg/day of paltusotine, the dose is then titrated to a maximum of 40 mg/day based on IGF-1 control and toleration. Despite delayed activation of many study sites due to the COVID-19 pandemic, Advance is expected to complete enrollment soon with an anticipated total of 41-43 of 49 eligible patients (84-88%). Open-label titration of paltusotine dose over the first 3-6 months of Advance study participation is complete for many subjects. As of June 1, 2021, 14 subjects have reached the Week 48 visit. An interim data cut is planned in August 2021, and a summary of key endpoints will be reported including summary statistics of IGF-1 and growth hormone (GH) compared to baseline. In addition, the incidence of treatment-emergent adverse events will be summarized. Analyses from this interim data snapshot will provide initial insights into the long-term safety and efficacy of paltusotine treatment for acromegaly.
Article tools
My recent searches
My recently viewed abstracts
Authors
Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
© Bioscientifica 2024 |
Privacy policy |
Cookie settings
BiosciAbstracts
Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Find out more