Clinical Trials v2

Spinogenix Clinical Trials

At Spinogenix, we are developing first-in-class therapeutics to restore synapses – the critical connections between neurons that allow us to think, plan, remember, and control motor functions. Understanding and restoring these synaptic connections could revolutionize treatments for a variety of neurodegenerative, neurodevelopmental, and neuropsychiatric conditions.

The nervous system, comprising the brain, spinal cord, and nerves, is responsible for your senses movement, basic bodily functions, learning, and memory. When this system breaks down, as it does in neurodegenerative conditions, the communication signals across synapses fail. This breakdown leads to the loss of cognitive and motor functions, profoundly impacting millions of lives.

Spinogenix is currently in Phase 2 clinical trials exploring our therapeutics for the treatment of ALS, Alzheimer’s disease, and Fragile X syndrome. Our therapies are a simple once-a-day pill for ease of treatment administration, aiming to restore synaptic function and make a meaningful impact for patients.

It is at your physician’s discretion to evaluate enrollment criteria and eligibility for clinical trial participation.

AMYOTROPHIC LATERAL SCLEROSIS (ALS)

We are currently recruiting for a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants.

The trial is open in Australia and soon to be in the USA. The FDA has approved the U.S. IND (IND 154637) and granted Orphan Drug Designation for SPG302 for the treatment of ALS.

CLINICAL TRIAL SITES ARE OPEN IN AUSTRALIA:

NCT05882695
Status: Recruiting

Locations:

  • Dr. Schultz at Flinders Medical Center in Adeliade, SA.
  • Dr. Henderson at the Royal Brisbane and Woman’s Hospital in Brisbane, Queensland
  • Dr. Rowe at Macquarie Hospital in North Ryde, N.S.W.

FOR OUR UPCOMING U.S. CLINICAL TRIALS:

NCT05882695
Status: not yet recruiting; please continue to check the status at ClinicalTrials.gov

Locations:


For additional information, please visit ClinicalTrials.gov

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Fragile X syndrome

Enrollment is pending for our Phase 2 study to evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.

The FDA has approved the U.S. IND (IND 169282) and granted Orphan Drug Designation for SPG601 for the treatment of FXS.

FOR OUR UPCOMING U.S. CLINICAL TRIAL:

NCT06413537
Status: not yet recruiting; please continue to check the status at ClinicalTrials.gov

Location:

  • Cincinnati, Ohio at Cincinnati Children’s Hospital Medical Center

For additional information, visit ClinicalTrials.gov

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Alzheimer's Disease

FOR OUR UPCOMING CLINICAL TRIAL IN AUSTRALIA:

Status: details coming soon