SPG302 / Spinogenix - LARVOL DELTA

Spinogenix Announces Open Enrollment for Phase 2 US Trial Following FDA Clearance of IND Application for SPG302, the First Synaptic Regenerative Therapy for Schizophrenia (PRNewswire) - "Spinogenix, Inc...announced open enrollment for its Phase 2 trial of SPG302 for the treatment of people with schizophrenia, following clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). The U.S.-based trial evaluating the efficacy, safety, and tolerability of once-daily dosing of SPG302 expands on trials underway in Australia."

Enrollment open • IND • Schizophrenia

Extension Study of Participants From SPG302-ALS-101 (clinicaltrials.gov) - P2 | N=16 | Not yet recruiting | Sponsor: Spinogenix

New P2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

Extension Study of Participants From SPG302-ALZ-101 (clinicaltrials.gov) - P2 | N=24 | Enrolling by invitation | Sponsor: Spinogenix | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Alzheimer's Disease • CNS Disorders

Extension Study of Participants From SPG302-ALZ-101 (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Spinogenix

New P2 trial • Alzheimer's Disease • CNS Disorders

Study of SPG302 in Healthy Volunteers and ALS Participants (clinicaltrials.gov) - P1 | N=112 | Active, not recruiting | Sponsor: Spinogenix | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders

Spinogenix Announces Launch of a Phase 2 Clinical Trial Evaluating SPG302 for the Treatment of Schizophrenia (GlobeNewswire) - "Spinogenix, Inc...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."

Trial status • Schizophrenia

SPG302-SCZ-201: Study of SPG302 in Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Spinogenix | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

SPG302-ALZ-101: Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: Spinogenix | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Spinogenix Announces Open Enrollment for Phase 2 Study Evaluating SPG302 for the Treatment of Alzheimer’s Disease (GlobeNewswire) - "Spinogenix...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 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."

Enrollment open • Alzheimer's Disease

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 (GlobeNewswire) - "Spinogenix...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)....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."

Trial status • Alzheimer's Disease • Amyotrophic Lateral Sclerosis

Study of SPG302 in Healthy Volunteers and ALS Participants (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Spinogenix | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: May 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

Spinogenix Announces FDA Clearance of IND Application for SPG302, a Novel Therapy for the Treatment of ALS (GlobeNewswire) - "Spinogenix, Inc...announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its Phase 1/2 clinical trial of SPG302 for the treatment of people with Amyotrophic Lateral Sclerosis (ALS). The trial will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of SPG302 dosed as a once-a-day pill in ALS patients."

IND • Trial status • Amyotrophic Lateral Sclerosis • CNS Disorders

Study of SPG302 in Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Spinogenix

New P2 trial • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Efficacy of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD) (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: Spinogenix

New P2 trial • Alzheimer's Disease • CNS Disorders

Novel Regenerative Drug, SPG302 Promotes Functional Recovery of Diaphragm Muscle Activity After Cervical Spinal Cord Injury (Neuroscience 2023) - "Treatment with SPG302 also ameliorated Pdi deficits following C2SH, with ~36% improvement compared to vehicle treatment during eupnea, ~40% during HH, ~25% during occlusion and ~14% during maximum Pdi. In summary, SPG302 is an exciting new therapeutic option for use to promote recovery after spinal cord injuries."

CNS Disorders

Spinogenix Announces Second Grant Award from U.S. Department of Defense to Further Advance SPG302, the First Synaptic Regenerative Drug to Treat Amyotrophic Lateral Sclerosis (ALS) (GlobeNewswire) - "Spinogenix, Inc...today announced that it has been awarded a new grant for nearly $1 million from the U.S. Department of Defense’s (DoD) Congressionally Directed Medical Research Programs (CDMRP). The support will allow Spinogenix to complete additional safety studies as required by the FDA to further advance development of the company’s lead clinical candidate SPG302 as a new potential regenerative treatment for Amyotrophic Lateral Sclerosis (ALS)."

Financing • Amyotrophic Lateral Sclerosis • CNS Disorders

Spinogenix Awarded $3 Million NIH Grant to Support Continued Development of SPG302, the First Synaptic Regenerative Therapeutic for Alzheimer’s Disease (GlobeNewswire) - "Spinogenix, Inc...today announced a second grant award by the National Institute of Health (NIH). The new $3 million grant...will continue to support the development of SPG302, a patent-protected compound designed by Spinogenix to help restore the brain connections and functions lost in Alzheimer’s disease and related neurodegenerative disorders."

Financing • Alzheimer's Disease • CNS Disorders

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302 in Healthy Volunteers and ALS Participants (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: Spinogenix | Not yet recruiting ➔ Recruiting

Enrollment open • Amyotrophic Lateral Sclerosis • CNS Disorders

Spinogenix Receives Approval from the Australia Human Research Ethics Committee to Initiate a Phase 1 Human Clinical Trial of SPG302, a Novel Regenerative Drug for the Treatment of Amyotrophic Lateral Sclerosis (ALS) (GlobeNewswire) - "Spinogenix...today announced that it is open to enrollment having received approval from Australia’s Human Research Ethics Committee (HREC) on June 26th to start human clinical trials with its novel drug SPG302 for the treatment of Amyotrophic Lateral Sclerosis (ALS)....'These human clinical trials will help us determine safety and tolerability in healthy volunteers and provide early signals of efficacy of our novel, first-in-class drug to help improve the lives of people with ALS.'"

Trial status • Amyotrophic Lateral Sclerosis • CNS Disorders

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPG302 in Healthy Volunteers and ALS Participants (clinicaltrials.gov) - P1 | N=112 | Not yet recruiting | Sponsor: Spinogenix

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

Novel regenerative drug, SPG302 promotes functional recovery of diaphragm muscle activity after cervical spinal cord injury. (PubMed, J Physiol) - "C SH depressed P , with SPG302 having improved P compared to vehicle treated. In conclusion, SPG302 presents a promising potential therapeutic for use in spinal cord injury."

Journal • Anesthesia • CNS Disorders • Musculoskeletal Diseases • Orthopedics

SPG302 Reverses Synaptic and Cognitive Deficits Without Altering Amyloid or Tau Pathology in a Transgenic Model of Alzheimer's Disease. (PubMed, Neurotherapeutics) - "Notably, SPG302 proved efficacious in this model without modifying Aβ and tau pathology. Thus, our study provides preclinical support for the idea that compounds capable of restoring synaptic density offer a viable strategy to reverse cognitive decline in AD."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • SYP