Spinogenix Announces Approval from the Australia Human Research Ethics Committee to Initiate a Phase 2 Human Clinical Trial of SPG302 for the Treatment of Alzheimer’s Disease
June 20 2024 - 8:00AM
Spinogenix, Inc., a clinical-stage biopharmaceutical company
pioneering first-in-class therapeutics that restore synapses to
improve the lives of patients worldwide, today announced that the
initiation of Spinogenix’s Phase 2 trial to evaluate SPG302 for the
treatment of adult participants with mild-to-moderate Alzheimer’s
disease (AD) was approved in Australia.
The Phase 2, multicenter study will assess the safety,
tolerability, pharmacokinetics, pharmacodynamics and clinical
efficacy of SPG302 in adult AD participants. The clinical trial
will consist of two parts: a pilot, placebo-controlled, randomized
safety and preliminary efficacy cohort (Part A) and an expansion
cohort (Part B). Additional information on the Phase 2 trial is
available on ClinicalTrials.gov (NCT06427668).
“Having gained approval from Australia’s HREC, this trial in
Alzheimer’s Disease will be the third Phase 2 study initiated by
Spinogenix across our pipeline this year,” said Stella Sarraf,
Ph.D., Spinogenix Chief Executive Officer and Founder. “This marks
a significant milestone in our rapid progress to bring truly
innovative therapeutic solutions to those battling
neurodegenerative and neurodevelopmental diseases. There remains a
significant unmet need for novel therapies that address the
underlying synaptic pathology central to AD and our first-in-class,
synaptogenic small molecule has the potential to provide a
meaningful clinical impact. We are developing SPG302 as a
once-a-day pill to further remove barriers to administration and
enable easier access so that patients around the world can
benefit.”
SPG302 has completed the Phase 1 safety study in healthy
subjects in Australia and is currently being evaluated in ALS
patients in Australia, with plans to enroll patients in the U.S.
following recent FDA IND clearance. Additional information on the
ALS trial may be found on ClinicalTrials.gov (NCT05882695)
About SPG302SPG302 is a once-a-day pill being
developed as a regenerative treatment for neurodegenerative and
neuropsychiatric diseases with the unique ability to restore
synapses, the key connections between neurons that allow people to
think, plan, remember, and control motor functions. The synaptic
regenerative activity of SPG302 represents a first-in-class
approach to treating these diseases and has the potential to
reverse declines in cognitive, respiratory, and motor function.
SPG302 has been granted U.S. FDA Orphan Drug Designation for the
treatment of ALS. Additional information on the clinical trials
evaluating SPG302 can be found on ClinicalTrials.gov (NCT05882695
and NCT06427668). SPG302 has received preclinical support from the
U.S. National Institutes of Health and the Department of
Defense.
About Alzheimer’s DiseaseAlzheimer’s Disease is
the most common cause of dementia, accounting for ~60-70% of
dementia cases worldwide. Loss of synapses occurs very early in
Alzheimer’s and is a major driver of progressive impairments in
cognition and memory. Currently, there is no cure for AD and
medications that are approved for use in AD have only modest and
temporary impact on symptoms.
About Spinogenix Spinogenix is dedicated
to developing transformative therapeutics for conditions involving
the loss or dysfunction of synapses. Our lead clinical-stage
synaptic regenerative candidate is a first-in-class therapeutic
designed to reverse synapse loss and improve cognitive and motor
functions in neurodegenerative and neuropsychiatric diseases such
as ALS, Alzheimer’s disease, and schizophrenia. In parallel, we are
also developing a synaptic function therapeutic designed to improve
behavior in Fragile X Syndrome. More information on Spinogenix can
be found at www.spinogenix.com or follow us on LinkedIn.
Spinogenix Contact
info@spinogenix.com
Media Contact
Kristin Politi, Ph.D.LifeSci
Communicationskpoliti@lifescicomms.com(646) 876-4783