CSTI-100 / HBS-102
MCHR1 antagonist for the treatment of rare neurological disorders.
Overview
In 2021 ConSynance reached an asset purchase agreement with Harmony Biosciences (HMBY) for an early clinical asset, CSTI-100, now renamed HBS-102. Harmony is currently evaluating the potential of HBS-102, a first-in-class MCHR1 antagonist, in a variety of rare neurological areas.
Harmony Biosciences holds the full development and commercialization rights globally, with the exception of Greater China. ConSynance holds the development and commercialization rights in Greater China.
For further information please refer to Harmony’s website: www.harmonybiosciences.com
Mechanism of Action
CSTI-500 modulates three monoamines involved in appetite, mood, and behaviors.
Tunable & Personalized Dosing
Relationship between CSTI-500 blood drug concentrations and transporter blockade
Why It Matters?
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Offers a potential single-agent approach for PWS’s complex neuropsychiatric profile.
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Enables personalized balance between efficacy & tolerability
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Uses PK-Guided, individualized dosing to keep each patient in the optimal therapeutic window
In short, CSTI-500’s tunable mechanism and individualized dosing strategy potentially offers a novel way to address the full spectrum of PWS symptoms safely and effectively.
Note: The clinical benefit of CSTI-500 has yet to be confirmed in trials, and further research is underway.
Clinical Development Status
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Generally safe and well-tolerated in Phase I studies in healthy volunteers (n = 87)
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Demonstrated CNS target engagement via Positron Emission Tomography (PET) imaging
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Phase I in PWS patients completed (n = 10), confirming PK and tolerability in the target population
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Phase II study initiating in 2025