Spinogenix, Inc.

LOS ANGELES, Oct. 16, 2024 (GLOBE NEWSWIRE) -- 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 Dr. Robert N. Weinreb, MD, has joined its science advisory board (SAB). The addition of Dr. Weinreb, Chair and Distinguished Professor of Ophthalmology at University of California San Diego, Director of the Shiley Eye Institute, brings world-leading clinical and research expertise in glaucoma to Spinogenix as the company plans to launch a new program to evaluate SPG302 as a potential neuroprotective therapeutic for glaucoma. Commenting on the Spinogenix glaucoma program, and his addition to the Company’s SAB, Dr. Weinreb noted, “Glaucoma-related vision loss has a profound impact on countless individuals worldwide. I am excited by the prospects of synaptic regeneration in glaucoma and the opportunity to act as a science advisor to Spinogenix as they begin advancing SPG302 for the treatment of glaucoma.” Glaucoma is the leading cause of irreversible blindness, affecting approximately 80 million people world-wide and over 3 million people in the United States. Vision loss in glaucoma stems from damage to the optic nerve and, eventually, the death of neurons in the retina (retinal ganglion cells, RGCs) whose axons give rise to the optic nerve as they transmit visual information from the eye to the brain. Currently, there is no cure for glaucoma. Existing treatments primarily focus on limiting disease progression using medications or surgical procedures that reduce intraocular pressure. Limitations of current glaucoma therapies have prompted the search for new, neuroprotective and regenerative strategies. Spinogenix is advancing SPG302 as a novel therapeutic approach for glaucoma. SPG302 is a clinical stage, orally administered small molecule therapeutic with the unique ability to rapidly regenerate glutamatergic synapses. These synapses, a key feature of retinal circuitry linking RGCs to light-sensing neurons in the retina, degenerate early in the course of glaucoma and other retinal neuropathies. By restoring glutamatergic synapses in the retina, SPG302 may offer a new way to help preserve or regain visual function in retinal diseases. In preclinical studies using a mouse model of glaucoma, SPG302 prevented glaucoma-associated changes in synaptic markers, while also preserving RGCs and their axons in the optic nerve. In addition, SPG302 partially restored retinal function. These results, which are being prepared for publication, support the idea that targeting synapse loss in glaucoma is neuroprotective and provide a foundation for clinical development of SPG302 in the disease. Dr. Stella Sarraf, CEO and Founder of Spinogenix, added, "The addition of Dr. Weinreb to our science advisory board comes at an important moment as we look to launch our glaucoma program. Our encouraging preclinical data have paved the way for the advancement of SPG302 as a novel therapeutic approach that could improve the lives of patients and families affected by glaucoma.” 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, motor and sensory functions. 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 (ALS: NCT05882695; Alzheimer’s Disease: NCT06427668; schizophrenia: NCT06442462). SPG302 has received preclinical support from the U.S. National Institutes of Health and the Department of Defense. 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, motor and sensory functions in neurodegenerative and neuropsychiatric diseases such as ALS, Alzheimer’s disease, schizophrenia and glaucoma. 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

Phase 2 trial is designed to evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia LOS ANGELES, Sept. 25, 2024 (GLOBE NEWSWIRE) -- 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 with the approval of the Australia Human Research Ethics Committee (HREC), multiple sites are currently enrolling participants in a Phase 2 clinical trial to evaluate SPG302 as a novel treatment for schizophrenia. Approximately 24 million people worldwide suffer from schizophrenia, a complex and highly debilitating neuropsychiatric disorder characterized by a trio of symptom domains: positive ( e.g. hallucinations, delusions), negative ( e.g. social withdrawal, anhedonia) and cognitive ( e.g. memory and language deficits). Spinogenix is focused on addressing a key feature of schizophrenia pathogenesis that may be a major contributor to all symptom domains: a loss of excitatory synapses that use the amino acid glutamate as a neurotransmitter ( i.e. glutamatergic synapses). Spinogenix is developing SPG302 as the first synaptic regenerative therapy for schizophrenia, with the potential to improve patient outcomes in all symptom domains. A wealth of data from histological, imaging, genetic and other studies implicate a loss of glutamatergic synapses in frontal cortex and other regions as a primary feature of schizophrenia pathogenesis, contributing to the onset of psychosis, negative symptoms and cognitive deficits 1 . SPG302 rapidly regenerates glutamatergic synapses through a novel mechanism of action. Spinogenix has initiated a randomized, double-blind, placebo-controlled multicenter Phase 2 study to assess the efficacy, safety, and tolerability of SPG302 administered once-daily as an oral tablet in adults with a primary diagnosis of schizophrenia. Additional information on the Phase 2 trial is available on ClinicalTrials.gov ( NCT06442462 ). “We are excited to advance the first clinical therapy capable of reversing synapse loss in schizophrenia, which may provide a much-needed advancement in the treatment of multiple symptoms and patients who are treatment resistant,” stated Dr. Stella Sarraf, CEO and Founder of Spinogenix. “Antipsychotics targeting dopamine signaling have been used since the 1950s to control positive symptoms, but leave psychosis inadequately controlled in many patients and have little benefit on negative and cognitive symptoms. As demonstrated by the expected entry of promising emerging antipsychotics into the schizophrenia treatment landscape, we are at an inflection point where new targets and novel approaches like SPG302 represent our best option to show meaningful improvements for this population.” Dr. Merv Turner, a member of the Spinogenix Board of Directors, shared, “The synaptic regenerative approach being championed by Spinogenix may add an important new option to the armamentarium of drugs available to those battling Schizophrenia. While long believed to be of potential benefit, targeting synapse loss in practice represents an entirely new therapeutic strategy. SPG302 has the potential to become another novel and high-value addition to the schizophrenia therapeutics space, following the expected entry of KarXT as the first non-dopamine antipsychotic in 70 years.” SPG302 has completed the Phase 1 safety study in healthy subjects in Australia and has U.S. FDA IND clearance for evaluation of ALS. SPG302 also received HREC approval for a Phase 2 trial in Alzheimer’s disease. Additional information on the ALS trial ( NCT05882695 ) and Alzheimer’s disease trial ( NCT06427668 ) may be found on ClinicalTrials.gov. About SPG302 SPG302 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 Schizophrenia Schizophrenia is a highly prevalent (0.5-1% of the population world-wide) and chronic psychiatric disorder associated with psychosis and a decline in daily functioning. Individuals with schizophrenia present with both positive and negative symptoms, as well as cognitive deficits. Positive symptoms include hallucinations, delusions, disorganized speech and abnormal movements, whereas negative symptoms include social withdrawal, anhedonia, apathy and lack of emotion. Together with co-morbid cognitive deficits, these symptoms have a major impact on the overall quality of life. Despite the availability of many drug therapies, psychosis in many patients remains inadequately controlled and both cognitive and negative symptoms are largely unaddressed. 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 or follow us on LinkedIn . Reference Howes OD, Onwordi EC. The synaptic hypothesis of schizophrenia version III: a master mechanism. Mol Psychiatry. 2023 May;28(5):1843-1856. doi: 10.1038/s41380-023-02043-w. Epub 2023 Apr 11. PMID: 37041418; PMCID: PMC10575788. Spinogenix Contact info@spinogenix.com Media Contact Kristin Politi, Ph.D. LifeSci Communications kpoliti@lifescicomms.com (646) 876-4783

SPG302 is a once-a-day pill with the potential to regenerate synapses to reverse declines in cognitive function in people with Alzheimer’s diseaseLOS ANGELES, Aug. 01, 2024 (GLOBE NEWSWIRE) -- 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 enrollment is now open in Australia for their Phase 2 clinical trial evaluating SPG302 for the treatment of people with Alzheimer’s disease (AD), the most prevalent form of dementia worldwide. “The SPG302 trials are a completely different approach to tackling Alzheimer’s Disease,” stated Bruce Brew, MD, DSc, FRACP, FAAN, neurologist and trial Principal Investigator at St. Vincent’s Hospital in Sydney, Australia. “Unlike other approaches, SPG302 has the prospect for some degree of regeneration and consequent improvement in memory, instead of just slowing the disease. This is a refreshing, long-awaited and cutting-edge approach to the disease, if it’s successful, it could be the dawn of a new era in treating Alzheimer’s disease.” “There are currently no approved drugs for Alzheimer’s disease that focus on restoring function to reverse the course of disease by targeting the synapses. At Spinogenix, our mission is to offer new hope to people battling AD, not just by slowing the disease but by potentially reversing it, offering a significant departure from conventional approaches” said Stella Sarraf, Ph.D., Spinogenix Chief Executive Officer and Founder. The Phase 2 trial will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of a once-a day pill of SPG302 in adult participants with mild-to-moderate Alzheimer’s disease. Enrollment is currently open at St. Vincents Hospital, Sydney, NSW, Australia with plans for a second site opening soon at Flinders Medical Center, Adelaide, SA, Australia. Additional information is available on ClinicalTrials.gov (NCT06427668). SPG302 is also being evaluated in Amyotrophic lateral sclerosis (ALS) patients in Australia, with plans to enroll ALS 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 SpinogenixSpinogenix is dedicated to developing transformative therapeutics for conditions involving the loss or dysfunction of synapses. Our lead clinical-stage synaptic regenerative drug, SPG302, 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 addition, we are developing a synaptic function therapeutic, SPG601, designed to improve cognitive and other symptoms in Fragile X Syndrome by correcting specific abnormalities in synaptic communication. 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