top of page
Consynance Logo.png

ConSynance Therapeutics Presents Overview of CSTI-500 at the

International Prader-Willi Syndrome Organization (IPWSO) 2024

Research and Clinical Trials Update Meeting

Sept 20, 2024

​

Our research director, Dr. Sarah Sheldrick, presented an overview of CSTI-500 at the IPWSO 2024 Research and Clinical Trials update meeting. CSTI-500 is a promising triple monoamine reuptake inhibitor in development for Prader-Willi Syndrome (PWS). Sarah’s presentation explained the compound’s ability to simultaneously regulate three key neurotransmitters—serotonin, dopamine, and norepinephrine—within multiple brain centers, aiming to address critical symptoms of PWS such as hyperphagia and temper outbursts. With its potential to provide a comprehensive treatment approach for PWS, and encouraging Phase 1 results in PWS, we are preparing to move forward with Phase 2 trials. 

​

​

​

​

​

​

​

​

​

​​

​

​

​

ConSynance Therapeutics Receives FDA Rare Pediatric Disease Designation for CSTI-500 in Prader-Willi Syndrome

July 24, 2024

​

ConSynance Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to its investigational drug CSTI-500. This designation is for the treatment of Prader-Willi Syndrome (PWS) in children and adolescents.

​

CSTI-500 is a first-in-class, orally administered Triple Monoamine Reuptake Inhibitor (TRI) designed to balance the neurotransmitters serotonin, dopamine, and norepinephrine, which are associated with the neuropsychiatric behaviors seen in PWS. The FDA's RPDD acknowledges the significant unmet medical need for this rare condition and provides ConSynance with the potential to receive a Priority Review Voucher upon FDA approval.

​

“Receiving RPDD from the FDA is a significant regulatory milestone for ConSynance as we prepare for the Phase 2 study of CSTI-500 for PWS,” said Shuang Liu, PhD, Founder and CEO of ConSynance. “PWS is a rare neurodevelopmental disorder characterized by hyperphagia and severe temper outbursts, among other neuropsychiatric behaviors. CSTI-500 targets the imbalance of three key neurotransmitters, serotonin, dopamine, and norepinephrine associated with these behaviors. CSTI-500 stands out as the first drug candidate for PWS designed to address both hyperphagia and severe temper outbursts, providing a potential breakthrough and comprehensive treatment solution for this challenging disorder.”

​

For more details, read the full press release.

 

 

 

 

ConSynance recognized as one of New York's top 12 women-led
biotech companies in 2023

Dec 23, 2023

​

ConSynance Therapeutics, under the leadership of CEO Shuang Liu, is delighted to have been recognized as one of the top 12 women-led biotech companies in 2023 by BiotechMetro.com. This accolade highlights ConSynance's innovative work in the field of central nervous system diseases, with a particular focus on advancing treatments for Prader-Willi Syndrome (PWS).

​

For more detailed information, please visit the BiotechMetro.com article.

 

 

ConSynance participates in the International Prader-Willi Syndrome

Organization (IPWSO) Research and Clinical Trials Update meeting

Sept 7, 2023

​

ConSynance was honored to participate in the IPWSO’s Research and clinical trials update meeting. During this meeting a comprehensive overview of ongoing, upcoming and recently concluded trials for PWS was showcased. Notably, Dr Jill Rasmussen, MD, Medical Advisor to ConSynance, delivered an update on CSTI-500, a promising treatment for PWS.

​

​

​

​

​

​

​

​

​

​

​

​

​

 

​

 

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.

image.png
image.png
image.png
image.png
image.png
image.png
image.png
bottom of page