NVG-291 / NervGen - LARVOL DELTA

NVG-291 in Spinal Cord Injury Subjects (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: NervGen Pharma | Trial completion date: Nov 2024 ➔ Apr 2026 | Trial primary completion date: Aug 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • CNS Disorders • Musculoskeletal Diseases • Orthopedics

NVG-291 in Spinal Cord Injury Subjects (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: NervGen Pharma

New P1/2 trial • CNS Disorders • Musculoskeletal Diseases • Orthopedics

NVG-291 in Spinal Cord Injury Subjects (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: NervGen Pharma | Phase classification: P1b/2a ➔ P1/2

Phase classification • CNS Disorders • Musculoskeletal Diseases • Orthopedics

NVG-291 Phase 1 Results and Phase 1b/2a Study Design in Individuals with Spinal Cord Injury (ACRM 2023) - "Understand the rationale for using electrophysiology as a surrogate for improved motor function. NVG-291 Phase 1 Results and Phase 1b/2a Study Design in Individuals with Spinal Cord Injury"

Clinical • P1/2 data • CNS Disorders • Orthopedics

NVG-291 in Spinal Cord Injury Subjects (clinicaltrials.gov) - P1b/2a | N=40 | Recruiting | Sponsor: NervGen Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Musculoskeletal Diseases • Orthopedics

A Phase I Safety Study of NVG-291 in Healthy Adults (clinicaltrials.gov) - P1 | N=74 | Completed | Sponsor: NervGen Pharma | Recruiting ➔ Completed | Trial completion date: Sep 2024 ➔ Jul 2023 | Trial primary completion date: Sep 2024 ➔ Jun 2023

Trial completion • Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

A Phase I Safety Study of NVG-291 in Healthy Adults (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: NervGen Pharma | Trial completion date: Mar 2023 ➔ Sep 2024 | Trial primary completion date: Mar 2023 ➔ Sep 2024

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

A Phase I Safety Study of NVG-291 in Healthy Adults (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: NervGen Pharma | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

NVG-291 Phase 1 Results and Phase 1b/2a Study Design in Individuals with mild cognitive impairment or mild dementia due to Alzheimer’s disease (CTAD 2022) - "NVG-291 appears well tolerated after administration of multiple ascending doses in healthy subjects. Upon completion this year, the Phase 1 study will establish the safety/tolerability/ pharmacokinetics of NVG-291 to support advancement to the Phase 1b/2a clinical trial in subjects with mild cognitive impairment or mild dementia due to AD. The Phase 1b/2a study in AD will assess change in functional and advanced structural imaging measures and cognition following treatment, with the trial expected to initiate in late 2022."

Clinical • P1/2 data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Migraine

"They should fast track NVG-291 only hope for nervous system repair ." (@helpkaran123)

NVG-291 Phase 1 Results and Phase 2 Study Design in Individuals with Relapsing-remitting Multiple Sclerosis (ECTRIMS 2022) - "NVG-291 appears well tolerated after administration of multiple ascending doses in healthy subjects. Upon completion this year, the Phase 1 study will establish the safety/tolerability/pharmacokinetics of NVG-291 to support advancement to the Phase 2 clinical trial in RRMS, which will assess change in clinical and advanced structural imaging measures following treatment."

Clinical • P1 data • P2 data • CNS Disorders • Migraine • Multiple Sclerosis • Solid Tumor

A Placebo-Controlled Phase I Study of NVG-291 in Healthy Subjects, Targeting CNS Receptor Protein Tyrosine Phosphatase Sigma (PTPσ) (ANA 2022) - "NVG-291 has been safe and well tolerated to date to support the advancement to clinical trials in SCI, MS, and AD, planned to initiate in 2022. Program and Abstracts, American Neurological Association S217"

Clinical • P1 data • Alzheimer's Disease • CNS Disorders

"I said about NVG291 not aHSCT" (@rscatch)

Bone Marrow Transplantation

A Phase I Safety Study of NVG-291 in Healthy Adults (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: NervGen Pharma | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • CNS Disorders • Orthopedics

A Placebo-Controlled Phase I Study in Healthy Subjects Assessing NVG-291, which Targets CNS Receptor Protein Tyrosine Phosphatase Sigma (PTPσ) (AAIC 2022) - No abstract available

Clinical • P1 data

NervGen Presenting Study Design for Upcoming Phase 1b/2a in Alzheimer's Disease at the 2022 Alzheimer's Association International Conference (Yahoo Finance) - “NervGen Pharma Corp…will present the study design for its upcoming Phase 1b/2a Alzheimer's disease clinical trial at the 2022 Alzheimer's Association International Conference (AAIC) on August 3, 2022. NervGen's Chief Medical Officer, Dr. Daniel Mikol, will present a poster summarizing unblinded data from the single ascending dose (SAD) cohort of the study and interim blinded data from the multiple ascending dose (MAD) portion of the study, and for the first time will introduce the study design for the upcoming Phase 1b/2a trial of NervGen's lead drug candidate, NVG-291, in subjects with mild cognitive impairment or mild dementia due to Alzheimer's disease.”

Clinical protocol • P1 data • Alzheimer's Disease • CNS Disorders

A Phase I Safety Study of NVG-291 in Healthy Adults (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: NervGen Pharma

New P1 trial • CNS Disorders • Orthopedics

A Placebo-Controlled Phase I Study of NVG-291 in Healthy Subjects, Targeting CNS Receptor Protein Tyrosine Phosphatase Sigma (PTPs) (AAN 2022) - "The safety and tolerability of NVG-291 and plasma exposure to date support advancement to clinical trials in patients with SCI, MS, and AD, planned for 2022."

Clinical • Alzheimer's Disease • CNS Disorders • Multiple Sclerosis • Orthopedics

NervGen Pharma to Present at 2022 Virtual Growth Conference Presented by Maxim Group (Yahoo Finance) - “NervGen Pharma Corp…will be presenting at the 2022 Virtual Growth Conference presented by Maxim Group, being held virtually on March 28-30, 2022. Paul Brennan, NervGen's President and CEO, will provide an overview of the Company's operations and the development plans for its lead compound, NVG-291. The presentation will be available via webcast on demand starting on Monday, March 28, 2022, at 9:00am ET…”

Review • Alzheimer's Disease • CNS Disorders

A Placebo-Controlled Phase I Study in Healthy Subjects Assessing NVG-291, which Targets CNS Receptor Protein Tyrosine Phosphatase Sigma (PTPσ) (Neuroscience 2021) - "Parts 1/2 are expected to complete in October 2021 and March 2022, respectively. The study will establish the safety and tolerability of NVG-291 and will measure exposure in the plasma and CSF, to support advancement to clinical trials in patients with SCI, MS, and AD in 2022."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders

[VIRTUAL] A Randomized, Triple-Blind, Placebo-Controlled Phase I Study of Single and Multiple Ascending Doses of NVG-291 in Healthy Subjects (ANA 2021) - "NVG291 has been safe and well-tolerated in subjects dosed to date. The study will establish whether NVG-291 is safe and well-tolerated at doses expected to be biologically active in humans, and will assess exposure in the CNS, in order to support advancement to clinical trials in patients with SCI, MS, and AD."

Clinical • Late-breaking abstract • P1 data • Alzheimer's Disease • CNS Disorders

NervGen Pharma Expands Alzheimer’s Disease Scientific Advisory Board (Newsfile) - "NVG-291, a modulator of downstream activity of highly inhibitory molecules, chondroitin sulfate proteoglycans (CSPGs) present in the central nervous system, promotes repair mechanisms such as axonal regeneration; remyelination; plasticity; autophagy (a cellular self-cleaning mechanism that removes unnecessary or dysfunctional components); and a non-inflammatory phenotype in microglia cells, the innate immune cells of the brain. NVG-291 modulates the inhibitory activity of CSPGs by inhibiting the protein tyrosine phosphatase (PTPσ) receptor which has been shown to impede repair following injury to the nervous system, whether as a result of trauma, such as in the case of spinal cord injury or traumatic brain injury, or disease-specific mechanisms, such as multiple sclerosis or Alzheimer's disease."

Media quote

NervGen Pharma Enters into Research Agreement with Sylics to Study NVG-291 in Alzheimer's Disease Models (Yahoo Finance) - "NervGen Pharma...announced today it has entered into a research agreement with Sylics Contract Research ('Sylics')...to study the effects of NVG-291 in mouse models of Alzheimer's disease....Preclinical studies have shown that, in addition to enhancing plasticity and modulation of microglial function, NVG-291 improves functional outcomes following damage to the nervous system by promoting key repair mechanisms such as axonal regeneration, remyelination, and autophagy. The data that we generate with Sylics will be an important step towards our Phase 1b Alzheimer's study, which we intend to initiate in 2022 upon the successful completion of the multiple ascending dose portion of our ongoing Phase 1 study."

Licensing / partnership • New P1 trial • Preclinical • Alzheimer's Disease • CNS Disorders