Phase II Ready Assets
CSTI-500 is an oral, once-per-day serotonin, dopamine and norepinephrine reuptake inhibitor (“TRI”). It is under development for the treatment of hyperphagia and other psychiatric co-morbidities in pediatric and adult PWS patients.
CSTI-500 addresses the dysregulated neurotransmission in the key brain centers in PWS patients. It is an optimally balanced triple reuptake inhibitor with unique pharmacological features that allow for predictable and safe titration to an efficacious dose tailored to the individual patient. CSTI-500 has the potential to provide a transformative therapy for Prader-Willi Syndrome, not only for hyperphagia but also many of its psychiatric co-morbidities.
CSTI-500 was found to be generally safe and well-tolerated and has a half-life of 50 hours in Phase I clinical trials. It also demonstrated CNS target engagement via positron emission tomography (PET).
ConSynance holds the exclusive global rights to CSTI-500 which was discovered and developed by Bristol-Myers Squibb and AMRI.
CSTI-100 is an oral, once-per-day, selective melanin-concentrating hormone (MCH) receptor 1 antagonist. MCH is an important neuropeptide regulating feeding behaviors through the MCHR1 receptors in the brain. The preclinical and clinical pharmacological profiles of CSTI-100 suggest that CSTI-100 addresses the core symptoms of PWS. In phase I studies of CSTI-100, healthy, overweight volunteers had up to a 47% suppression of hunger on a visual analog scale after 14 days of dosing suggesting the potential to treat hyperphagia in PWS patients.
CSTI-100 was found to be safe and well tolerated in Phase I studies with a 26-hour half-life in lean and overweight humans.
ConSynance holds the exclusive global rights to CSTI-100 which was discovered and developed by AMRI.