Tazbentetol

Tazbentetol, a First-in-Class, Oral Synaptic Regenerative Investigational Therapy, Demonstrated Favorable Safety Profile and Durable Therapeutic Benefits Clinical Case Study Presented at AAIC Highlights Caregiver Report of Rapid Cognitive Improvement with Supporting Clinical Outcome Measures Consistent with Durable Treatment Benefit Through 18 Months LOS ANGELES, July 14, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced extended data from patients who continued treatment under a compassionate use Special Access Scheme (SAS) following its completed Phase 2a trial evaluating Tazbentetol (SPG302) for the treatment of Alzheimer's disease (AD). Once-daily treatment with Tazbentetol, a first-in-class synaptic regenerative investigational therapy, initially demonstrated rapid improvement in multiple measures of cognition during placebo-controlled and open label extension periods of the Phase 2a trial and has shown sustained improvement for up to 84 weeks in patients participating in the SAS program. Participants treated with tazbentetol under the SAS program had previously completed a Phase 2a study (NCT06427668) in Australia that assessed the safety, tolerability, and preliminary clinical efficacy of tazbentetol in 24 patients with mild-to-moderate AD. The trial consisted of a 4-week double-blind placebo-controlled period in which participants received 150mg or 300mg tazbentetol QD (or placebo), followed by an open label extension (OLE) period during which all participants received 300mg tazbentetol through 24 weeks. Key findings from the Phase 2a trial were presented at CTAD 2025, including: favorable safety and tolerability, both as a monotherapy and in combination with standard-of-care medications (e.g. donepezil); rapid cognitive improvement with a > 2-point average increase in the Standardized Mini-Mental Status Examination (SMMSE) during the 4-week placebo-controlled period (p < 0.05) that was sustained through the 24-week OLE period; a rapid reduction (improvement) in scores on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores, an FDA-acceptable endpoint to demonstrate efficacy, with a -0.81 point reduction over 24 weeks and continued improvement through longer term follow-up. At the conclusion of the trial, participants had the option to remain on treatment through a SAS for up to two years at 300mg QD and some participants have now completed 84 weeks of treatment. Extended treatment results presented at AAIC 2026: At this year's AAIC meeting, the Phase 2a data were presented alongside new observations on the durability of cognitive improvement over the SAS period in a case study highlighting correspondence between clinical outcome measures and caregiver-reported observations of cognitive improvement. Group data of SMMSE scores support continued treatment benefit beyond 1 year, including some patients remaining improved over baseline at 84 weeks (~19 months) of treatment. "We are excited to share these extended data with the Alzheimer's community, demonstrating the potential of tazbentetol as an efficacious and well-tolerated treatment," said Dr. Stella Sarraf, Chief Executive Officer and Founder of Spinogenix. "This new data demonstrates the long-term durability of tazbentetol's cognitive benefits and its potential." An illustrative case study from extended Phase 2a trial: Spinogenix presented a case study of a 72-year-old woman with mild AD presenting with short-term memory loss, anomia, and impaired social skills and etiquette. Within three months of treatment with 300mg tazbentetol, her caregiver reported that she was markedly improved, regaining the ability to read books, follow movies, and recall story lines. These observable improvements were clinically corroborated by rapid improvements in her scores on the SMMSE (a 4 to 6-point increase through 3 months) and CDR-SB (a 2.5 decrease through 3 months, with further reduction at 24 weeks) outcome measures. SMMSE scores showed continued improvement over baseline out to latest visit of 81 weeks. "I look forward to supporting the company's efforts in planning their next Alzheimer's trial to advance a first-in-class synaptic regenerative therapy in the field," said Steven Arnold, MD, Professor of Neurology at Harvard Medical School and member of the Spinogenix Scientific Advisory Board. About Spinogenix   Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction.  Spinogenix is developing two novel therapeutics: Tazbentetol (SPG302), a synaptic regenerative therapy designed to restore cognitive, motor, and other functions in Alzheimer's disease, ALS, schizophrenia and other diseases; and SPG601, a synaptic corrective therapy designed to work at the BK channel to normalize brain activity and help with core symptoms in Fragile X Syndrome (FXS). The company has received Orphan Drug designations from FDA and EMA for tazbentetol in ALS as well as FDA Orphan Drug and Fast Track designations for SPG601 in FXS. More information on Spinogenix can be found at or follow us on LinkedIn.  Media Contact: Daniel Davis FINN Partners [email protected] Investor Relations Contact:  Sasha Damouni Ellis Spinogenix, Inc.  [email protected] SOURCE Spinogenix 21% more press release views with Request a Demo

Prof. Coyle to Provide Guidance on Company's Neuroscience Pipeline, with Emphasis on Schizophrenia LOS ANGELES, July 2, 2026 /PRNewswire/ -- Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering novel therapeutics that have the potential to restore synapses to improve the lives of patients worldwide, today announced the appointment of Prof. Joseph T. Coyle, MD, a globally recognized expert in psychiatry and neuroscience, to its Scientific Advisory Board (SAB). The appointment comes as Spinogenix advances the clinical development of tazbentetol (formerly SPG302) across multiple neurodegenerative and neuropsychiatric indications. Prof. Coyle, the Eben S. Draper Chair of Psychiatry and Neuroscience at Harvard Medical School, will provide strategic scientific guidance across the company's neuroscience pipeline, with a particular focus on schizophrenia. "We are thrilled to welcome Prof. Coyle to Spinogenix's Scientific Advisory Board at this important stage in the development of tazbentetol," said Dr. Stella Sarraf, CEO and Founder of Spinogenix. "Prof. Coyle's pioneering work in neuropsychiatric research has shaped the current understanding of schizophrenia and other brain disorders. His expertise, particularly in advancing EEG biomarkers and translating neuroscience discoveries into clinical development, will be instrumental as we advance our schizophrenia program. Prof. Coyle has spent more than four decades advancing the understanding of brain function and neuropsychiatric disease. An established expert in developmental neurobiology, glutamatergic signaling, neuronal vulnerability, and psychopharmacology, he has authored more than 500 scientific publications and is among the most highly cited researchers in neuroscience. "Schizophrenia remains a highly complex neuropsychiatric disorder, highlighting the need for therapies that address its underlying biology," said Prof. Coyle. "I have been particularly impressed by Spinogenix's novel synaptic regenerative approach to treating neurological conditions, as well as the company's commitment to integrating EEG into the clinical development of tazbentetol. I look forward to supporting the team as it continues developing this essential program." Throughout his distinguished career, Dr. Coyle has held numerous leadership positions, including Chairman of the Department of Psychiatry at Harvard Medical School, President of the Society for Neuroscience, and President of the American College of Neuropsychopharmacology. He is a member of the National Academy of Medicine, a Fellow of the American Academy of Arts and Sciences, and has served on numerous national advisory committees and editorial boards. His research has been continuously funded by the National Institutes of Health (NIH) for over 30 years and has been cited more than 87,000 times. About Spinogenix Current treatments for neurodegenerative, neuropsychiatric and neurodevelopmental conditions primarily focus on slowing disease progression or minimizing symptoms, leaving many without hope for improvement. Spinogenix is aiming to transform the treatment of these conditions through its pioneering first-in-class and paradigm-shifting synaptic regenerative and synaptic corrective therapeutics designed to restore depleted synapses and reverse synaptic degeneration and dysfunction. Spinogenix is developing two novel therapeutics: Tazbentetol (SPG302), which is designed to trigger neurons to produce new glutamatergic synapses and restore cognitive, motor, and other functions in ALS, Alzheimer's disease, schizophrenia and other diseases; and SPG601, which is designed to work at the synaptic level to correct specific dysfunctions in Fragile X Syndrome (FXS) that underlie many core symptoms. The company has received Orphan Drug designations from FDA and EMA for tazbentetol in ALS as well as FDA Orphan Drug and Fast Track designations for SPG601 in FXS. More information on Spinogenix can be found at or follow us on LinkedIn. Media Contact: Daniel Davis FINN Partners [email protected] Investor Relations Contact: Sasha Damouni Ellis Spinogenix, Inc. [email protected] SOURCE Spinogenix 21% more press release views with Request a Demo