CSTI-500 / BMS, Curia, ConSynance - LARVOL DELTA

ConSynance Therapeutics Announces First Patient Dosed in Phase 2a Clinical Trial of CSTI-500 for Prader-Willi Syndrome (GlobeNewswire) - "The Phase 2a study is a proof-of-concept, open-label clinical trial designed to evaluate the safety, tolerability, and exploratory efficacy of CSTI-500 in individuals with PWS. The study is expected to enroll approximately 12 participants aged 13 to 50 years and is being conducted at Vanderbilt University Medical Center."

Trial status • Prader–Willi syndrome

A Study of CSTI-500 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: ConSynance Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Prader–Willi syndrome

A Study of CSTI-500 in Patients With Prader-Willi Syndrome (clinicaltrials.gov) - P2 | N=12 | Not yet recruiting | Sponsor: ConSynance Therapeutics

New P2 trial • Prader–Willi syndrome

Ascending single-dose study of the safety, pharmacokinetics, and pharmacodynamics of CSTI-500, a novel monoamine triple reuptake inhibitor, first-in-human. (PubMed, Psychopharmacology (Berl)) - "CSTI-500 is a potent monoamine TRI with substantial striatal SERT and moderate DAT occupancies in healthy subjects. Together with promising safety-tolerability and pharmacokinetics profiles, the continued clinical development of CSTI-500 is strongly supported."

Journal • P1 data • PK/PD data

ConSynance Therapeutics Announces U.S. FDA Grants Rare Pediatric Disease Designation to CSTI-500, a Potential First-in-Class Therapy for Prader-Willi Syndrome (GlobeNewswire) - "ConSynance Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investigational drug CSTI-500 for the treatment of Prader-Willi Syndrome (PWS) in children and adolescents....CSTI-500 has been studied in nearly 100 humans across three Phase 1 clinical trials, including 10 PWS patients, setting the stage for a Phase 2 study expected to commence in 2025."

FDA event • New P2 trial • CNS Disorders • Prader–Willi syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: ConSynance Therapeutics | Recruiting ➔ Completed

Trial completion • Prader–Willi syndrome

ConSynance Therapeutics Reports Positive Phase 1 Results for CSTI-500 in Prader-Willi Syndrome Patients (GlobeNewswire) - P1 | N=14 | NCT05504395 | Sponsor: ConSynance Therapeutics | "ConSynance Therapeutics...today announced positive results from its Phase 1 trial for CSTI-500, a potential groundbreaking treatment for Prader-Willi Syndrome (PWS)....CSTI-500 has previously completed Phase 1 Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies in healthy volunteers, generating valuable safety, pharmacokinetics and brain target engagement data. The robust pharmacokinetic and safety data of CSTI-500 in PWS patients provide strong support to proceed to a Phase 2 study."

P1 data • CNS Disorders • Prader–Willi syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: ConSynance Therapeutics | Trial primary completion date: Nov 2022 ➔ Feb 2023

Trial primary completion date • Prader–Willi syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: ConSynance Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Prader–Willi syndrome

A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: ConSynance Therapeutics

New P1 trial • Prader–Willi syndrome