Clinical Trials
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.
Compassionate Use Policy (Expanded Access)
At Spinogenix, our mission is to develop innovative treatments for serious and life-threatening conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer’s disease. We understand that patients who do not qualify for clinical trials may seek access to investigational therapies. In certain cases, we may provide access to our investigational products outside of clinical trials through compassionate use, also known as Expanded Access.
Eligibility:
- U.S. Only
- The patient has a serious or life-threatening condition, such as ALS or Alzheimer’s disease, for which no satisfactory treatment options are available.
- The patient is not eligible to participate in a clinical trial for the investigational therapy, either due to geographic limitations or because the trial is no longer enrolling.
- The use of the investigational drug in the requested manner will not interfere with ongoing clinical trials or the overall drug development process.
Request Process: Compassionate use requests can only be submitted by a licensed physician on behalf of a patient. To submit a request, the physician should provide relevant medical history and justification for the need for access to the investigational therapy.
Contact: For more information or to submit a request, please contact us at
info@spinogenix.com. We will respond to all requests as quickly as possible.
Additional Information: Please note that compassionate use may be limited by the availability of the investigational product and ongoing clinical trials. More information about Spinogenix’s clinical trials can be found at clinicaltrials.gov.
SPINOGENIX IS COMMITTED TO DISCOVERING AND PROVIDING THE WORLD WITH NOVEL THERAPIES AND TREATMENTS, INCLUDING OUR SPG302 AND SPG601 CANDIDATES, FOR ADDRESSING SOME OF THE MOST DEBILITATING DISEASES. ALL OF OUR INVESTIGATIONAL DRUGS ARE STILL IN CLINICAL TRIALS AND ARE NOT APPROVED FOR ANY USE OR UNDER ANY CIRCUMSTANCE OUTSIDE OF OUR CLINICAL TRIALS. SINCE SPINOGENIX IS THE SOLE MANUFACTURER OF THESE THERAPEUTICS AND WE HAVE NOT LICENSED OR AUTHORIZED ANY THIRD PARTY TO MANUFACTURE THEM, IF YOU ACQUIRE SPG302 OR SPG601 FROM ANYONE OTHER THAN SPINOGENIX, IT IS MANUFACTURED BY A COUNTERFEITER. AS SUCH WE CANNOT, AND DO NOT, GUARANTEE ITS EFFICACY OR SAFETY. SPINOGENIX STRONGLY ADVISES AGAINST PURCHASING AND USING ANY SUCH PRODUCTS AS THEY MAY POSE SIGNIFICANT HEALTH RISKS (INCLUDING UNINTENDED AND/OR UNKNOWN LIFE-THREATENING SIDE EFFECTS). SPINOGENIX STRONGLY URGES YOU TO SEEK PROFESSIONAL MEDICAL ADVICE AND GUIDANCE AS TO LEGAL, SAFE AND APPROVED TREATMENTS FOR YOUR DISEASE.
Alzheimer's Disease
We are currently recruiting for our Phase 2 study to evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate Alzheimer’s disease (AD).
ALS
We are fully enrolled and not recruiting for a Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SPG302 in healthy volunteers and ALS participants.
Fragile X syndrome
We are fully enrolled and not recruiting for a Phase 2 study to evaluate the safety, efficacy, tolerability, pharmacokinetics and pharmacodynamics of SPG601 in adult men with Fragile X syndrome.
Schizophrenia
We are currently recruiting for our Phase 2 study to evaluate the efficacy, safety, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.
