ConSynance Therapeutics Reports Positive Phase 1 Results for CSTI-500 in Prader-Willi Syndrome Patients
May 30, 2023
ConSynance today announced positive results from its Phase 1 trial for CSTI-500, a potential groundbreaking treatment for Prader-Willi Syndrome (PWS).
In the study conducted at Vanderbilt Medical Center in Nashville, Tennessee, CSTI-500, a Triple Monoamine Reuptake Inhibitor (TRI), demonstrated a strong safety profile with no severe adverse events. Importantly, its pharmacokinetics closely align with earlier observations in healthy volunteers. Furthermore, the pharmacokinetics data confirm the bioequivalence of the newly developed capsule formulation. With these compelling findings, CSTI-500 is now poised to advance into a Phase 2 clinical trial.
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.
"CSTI-500 has the potential to significantly improve the lives of PWS patients and their loved ones by addressing two of the most debilitating symptoms - hyperphagia and temper outbursts," stated Shuang Liu, CEO and Founder of ConSynance, and co-inventor of CSTI-500. "These encouraging results from PWS patients underscore CSTI-500's potential as a promising therapeutic candidate, bringing us one step closer to fulfilling the substantial unmet medical needs in the PWS community."
Read the full press release here.
First participant enrolled onto pharmacokinetic and safety study of CSTI-500 in subjects with Prader-Willi Syndrome (PWS）
November 14, 2022
ConSynance is pleased to announce that the first two participants have been enrolled onto its open-label, single-center, Phase 1 study. This study will evaluate the PK and safety of a 10 mg single oral dose of CSTI-500, a triple monoamine reuptake inhibitor (TRI), in people with PWS.
Overall the study is looking to recruit 14 individuals between the ages of 13 and 50 years. Eligible participants will attend five in-clinic site visits at Vanderbilt University Medical Center for PK blood draws and safety assessments over a 6-day period. The study will consist of a Screening Period 1-3 days prior to the Baseline Visit. In addition to the Screening Visit, eligible participants will attend five in-clinic site visits for PK blood draws and safety assessments over a 6-day period. At Visit 2 all subjects will receive one single oral dose of CSTI-500 10 mg.
For more information please refer to the trial listing: ClinicalTrials.gov (NCT05504395)
ConSynance sponsors the 4th Pituitary Brain Tumor Virtual Family Conference
November 5, 2022
ConSynance is a proud sponsor of the 4th Pituitary Brain Tumor Virtual Family Conference, to be held via Zoom on November 5, 2022. The conference will explore the landscape of research on pituitary brain tumors, what is currently being studied, as well as current and future clinical trials.
Information about the event can be found here.
ConSynance proudly sponsors and will participate in the 2022 Foundation for Prader-Willi Research (FPWR) Symposium and Family Conference
September 26, 2022
ConSynance is proud to be a sponsor of the 2022 FPWR Symposium and Family Conference which is being held in Chicago, IL from September 29 – October 1, 2022.
Information about the event can be found here.
ConSynance is starting a pharmacokinetic and safety study of CSTI-500 in subjects with Prader-Willi Syndrome (PWS）
September 25, 2022
ConSynance has listed on clinicaltrial.gov an open-label, single center, Phase 1 study (NCT05504395) to evaluate the PK and safety of a 10 mg single oral dose of CSTI-500, a triple monoamine reuptake inhibitor (TRI), in patients with genetically confirmed PWS. The trial is planned to initiate in October 2022 and approximately 14 patients aged 13 to 50 years who meet all eligibility criteria will receive one single dose of CSTI-500. This study marks the first clinical study of CSTI-500 involving this population
Further information about the study can be found here.
Global Business Reports interviews ConSynance CEO, Shuang Liu
August 11, 2022
Global Business Reports (GBR) recently interviewed ConSynance CEO Shuang Liu and the full interview can be found here. Excerpts from Shuang’s interview were incorporated into GBR’s United States Life Sciences 2022 Digital Report. This report brings together contributions from over 80 industry leaders whose experiences collectively span all areas of the Life Sciences sector.
GBR was established in 2001 in order to provide up to date and first hand information for global business decision makers: www.gbreports.com
ConSynance will participate in BIO International Convention 2022
May 19, 2022
The upcoming BIO International convention is back in-person for 2022, to be held in San Diego, California from June 13-16. ConSynance are looking forward to four days of networking, programming, and partnering opportunities.
Schedule a One-on-One Partnering™ in-person meeting with ConSynance or contact us here.
ConSynance sponsors and will participate in the 11th International Prader-Willi Syndrome Organisation (IPWSO) conference 2022
May 15, 2022
ConSynance is glad to be a sponsor of the 11th IPWSO Conference which is being held in Limerick, Ireland, from July 6 - 10, 2022. CEO Shuang Liu will be attending and presenting a poster at the upcoming conference, titled: CSTI-500 – A Novel Triple Reuptake Inhibitor for the Management of Symptoms Associated with PWS: Delivery via a Unique, Individualized, PK-guided Dosing Approach
11th IPWSO Conference 2022 - IPWSO
ConSynance sponsors the Prader-Willi Alliance of New York (PWANY) 30th Annual Conference
May 10, 2022
ConSynance is glad to be a sponsor of the PWANY conference, to be held in Binghamton, NY, on May 20 – 21, 2022. ConSynance CEO Shuang Liu will be attending.
Conference Information – Prader-Willi Alliance of New York, Inc.
Partnership with Harmony Biosciences to Develop and Commercialize CSTI-100 (now HBS-102)
August 9, 2021
We are very excited to announce the signing of a partnership agreement with Harmony Biosciences. Under the terms of the agreement, Harmony Biosciences will acquire the full development and commercialization rights globally, with the exception of Greater China, of CSTI-100 (now HBS-102), a Melanin Concentrating Hormone Receptor 1 (MCHR1) antagonist. HBS-102, a potential first-in-class molecule with a novel mechanism of action, has the potential to offer a novel approach to the treatment of narcolepsy including the symptoms of Rapid Eye Movement (REM) sleep dysregulation, such as cataplexy, hallucinations, and sleep paralysis. The financial terms include an upfront payment of $3.5 million and potential development and regulatory milestone payments and royalties. Please also see the press release from Harmony.