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ConSynance Therapeutics Reports Positive Phase 1 Results


RENSSELAER, New York, May 30, 2023 (GLOBE NEWSWIRE) —

ConSynance Therapeutics, Inc., an emerging biopharmaceutical firm focused on developing novel therapies for rare central nervous system (CNS) disorders, 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.

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“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 Therapeutics, 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.”

More About CSTI-500: CSTI-500 is a first-in-class, orally administered New Chemical Entity (NCE) and an optimally balanced Triple Monoamine Reuptake Inhibitor (TRI). It is specifically designed to regulate, with an optimal ratio, the reuptake of serotonin, dopamine, and norepinephrine—three vital neurotransmitters involved in many neuropsychiatric and neurological functions, such as feeding behaviors, mood, and sleep. The unique balance of these elements by CSTI-500 has been demonstrated by brain target engagement data in healthy volunteers. This feature has the potential to safely and effectively mitigate hyperphagia and temper outbursts, two prominent neuropsychiatric symptoms in PWS patients. These symptoms are often linked to neurotransmitter deficiencies found not only in PWS patients but also in those suffering from other diseases associated with dysregulated monoamine signaling.

About PWS: PWS is a rare neurodevelopmental genetic disorder that affects approximately 1 in 15,000 live births. It is initially characterized by severe hypotonia and failure to thrive. Over time, it evolves into a life-threatening obsession with food beginning in early childhood, which is compounded by various neuropsychiatric symptoms, notably temper outbursts, and endocrinological disorders. To date, the only approved treatment for PWS addresses short stature, with growth hormones, with no approved treatments tackling the core symptoms of the disorder.

About ConSynance Therapeutics: ConSynance is a New York-based biopharmaceutical company that has dedicated itself to developing innovative therapies for rare CNS disorders. The company has strategically in-licensed three CNS assets, each in varying stages of development, from early clinical to pre-clinical. Further demonstrating its commitment to breakthrough treatments, ConSynance is also engaged in an ongoing partnership with Harmony Biosciences to develop HBS-102 (formerly known as CSTI-100), highlighting the company’s collaborative approach and its drive to bring effective therapies to patients in need.

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Forward-Looking Statements: This press release contains forward-looking statements based on ConSynance Therapeutics Inc.’s current expectations and beliefs. These statements are subject to various risks and uncertainties, and actual results may differ. ConSynance Therapeutics Inc. accepts no obligation to update or revise any forward-looking statement, except as required by law. 

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