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Gain Therapeutics
Gain Therapeutics (GANX) investor relations material
Gain Therapeutics Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Update summary6 Jan, 2026
Study design and patient population
Phase 1b open-label study in Parkinson's disease enrolled 21 patients, with 19 completing the first 90 days and 15 continuing into an open-label extension phase.
All patients received GT-02287 for 90 days, with the option to continue for up to 12 months.
The trial was conducted across seven sites in Australia, focusing on safety and tolerability after three months of dosing.
Four patients were excluded from MDS-UPDRS analysis due to baseline or measurement criteria.
Clinical outcomes and UPDRS scores
Average improvement of 2.2 points in combined MDS-UPDRS Part II and III scores after 90 days among 15 analyzed patients.
Among 13 of 15 evaluable patients, a greater improvement of around four points was observed.
Anecdotal improvements were noted in balance, gait, and sense of smell, with stabilization in MDS-UPDRS scores.
No changes in dopamine administration were required for any subjects during the study.
Biomarker findings and mechanistic insights
GT-02287 led to an 81% average reduction in CSF glucosylsphingosine (GluSph) after 90 days, indicating increased GCase activity in the brain.
Reduction in GluSph is a first-ever observation for a GCase modulator in PD patients, suggesting potential to impact disease progression.
Decrease in CSF glucosylsphingosine observed in patients with elevated baseline levels after 90 days of treatment.
Reduction in glucosylsphingosine in CSF correlates with improvements in UPDRS scores.
Glucosylsphingosine is a more reliable biomarker for GCase pathway engagement than glucosylceramide.
How does GluSph data inform future trial design?
Interpret MDS-UPDRS data given study limitations
What specific outcomes are expected from 12-month data?
GlcSph as Phase 2 patient selection marker
Expected duration for clinical significance?
Impact of specific GBA mutations on response?
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Next Gain Therapeutics earnings date
Q4 202527 Mar, 2026
Gain Therapeutics
Next Gain Therapeutics earnings date
Q4 202527 Mar, 2026
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Frequently asked questions
Gain Therapeutics Inc. is a biotechnology firm engaged in the research and development of innovative therapies aimed at treating diseases caused by protein misfolding, with a focus on rare genetic diseases and neurological disorders. Utilizing its Site-Directed Enzyme Enhancement Therapy (SEE-Tx) platform, the company identifies allosteric sites on misfolded proteins to discover proprietary small molecules that can bind to these sites, thereby restoring proper protein folding and addressing the underlying disease. Gain Therapeutics' lead product candidate is GT-02287, which targets GBA1 Parkinson's disease. Additionally, the company is advancing structurally targeted allosteric regulator candidates for a range of conditions, including Morquio B, GM1 gangliosidosis, neuronopathic Gaucher disease, GBA1 Parkinson's, Krabbe, and Mucopolysaccharidosis type 1 diseases. Gain Therapeutics is headquartered in Bethesda, Maryland, and its shares are listed on the NASDAQ under the ticker symbol GANX.
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