NTI164 / Neurotech International - LARVOL DELTA

TRANSCEND: Efficacy and Safety of NTI164 in Children and Young Adults With Rett Syndrome (clinicaltrials.gov) - P2/3 | N=40 | Not yet recruiting | Sponsor: Fenix Innovation Group

New P2/3 trial • Developmental Disorders • Movement Disorders

HarmonyPlus: NTI164 in Autism Spectrum Disorder (clinicaltrials.gov) - P3 | N=98 | Not yet recruiting | Sponsor: Fenix Innovation Group

New P3 trial • Autism Spectrum Disorder • Genetic Disorders

Neurotech International has passed an important regulatory milestone with the US Food and Drug Administration (FDA) granting Rare Paediatric Disease Designation (RPDD) for its lead drug candidate NTI164 for the treatment of Rett syndrome. (The Australian)

FDA event • Rare Diseases

A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT) (ANZCTR) - P1/2 | N=14 | Active, not recruiting | Sponsor: Fenix Innovation Group | Recruiting ➔ Active, not recruiting

Enrollment closed • Developmental Disorders • Movement Disorders

Investigating the effects of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) on paediatric acute-onset neuropsychiatric syndrome (PANS): An open-label study. (ANZCTR) - P1/2 | N=15 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Pediatrics • Psychiatry

Evaluating the Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in Young People with Autism Spectrum Disorder, a Double-Blind, Randomised and Controlled-to-Open-Label Study. (ANZCTR) - P2/3 | N=54 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Autism Spectrum Disorder • Genetic Disorders

Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) Improves Symptoms of Rett Syndrome: An Open-Label Study. (PubMed, J Paediatr Child Health) - "NTI164 demonstrated safety and improved some clinical and functional outcomes in RTT. These improvements justify ongoing research into NTI164, which may be a potential adjunct therapy in RTT."

Journal • CNS Disorders • Developmental Disorders • Inflammation • Mood Disorders • Movement Disorders • Psychiatry • Respiratory Diseases

NTI164 Human PK Study (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Active, not recruiting | Initiation date: Dec 2024 ➔ Feb 2024

Enrollment closed • Trial initiation date

NTI164 Human PK Study (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Fenix Innovation Group

New P1 trial

Evaluation of the Efficacy of a Full-Spectrum Low-THC Cannabis Plant Extract Using In Vitro Models of Inflammation and Excitotoxicity. (PubMed, Biomolecules) - "NTI-164 promoted undifferentiated neuron proliferation and differentiated neuron survival under excitotoxic conditions. These effects suggest the potential for NTI-164 as a treatment for neuropathologies."

Journal • Preclinical • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders • Genetic Disorders • Inflammation • Psychiatry

CannaPANS: Investigating The Effects Of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) On Paediatric Acute-onset Neuropsychiatric Syndrome (PANS) (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Fenix Innovation Group

New P1/2 trial • Pediatrics • Psychiatry

Assessing the Safety and Efficacy of Full-Spectrum Medicinal Cannabis Plant Extract 0.08% THC (NTI164) in the Treatment of Rett Syndrome (RTT) (clinicaltrials.gov) - P1/2 | N=14 | Active, not recruiting | Sponsor: Fenix Innovation Group

New P1/2 trial • Developmental Disorders • Movement Disorders

A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT) (ANZCTR) - P1/2 | N=14 | Recruiting | Sponsor: Fenix Innovation Group | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Developmental Disorders • Movement Disorders

A Phase I/II study to assess the safety and efficacy of full-spectrum medicinal cannabis plant extract 0.08% THC (NTI164) in the treatment of Rett syndrome (RTT) (ANZCTR) - P1/2 | N=14 | Not yet recruiting | Sponsor: Fenix Innovation Group

New P1/2 trial • Developmental Disorders • Movement Disorders

Neurotech International completes recruitment for PANDAS/PANS clinical trial (SmallCap Network) - "Neurotech International (ASX: NTI) has completed recruitment for a phase I/II trial assessing its lead candidate NTI164 in children with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS)."

Enrollment closed • Autism Spectrum Disorder • CNS Disorders • Developmental Disorders

Evaluating the Efficacy of NTI164 in Young People With Autism Spectrum Disorder (clinicaltrials.gov) - P2/3 | N=54 | Not yet recruiting | Sponsor: Fenix Innovation Group

New P2/3 trial • Autism Spectrum Disorder • Genetic Disorders

Safety and Efficacy of Oral Full-Spectrum Medicinal Cannabis Plant Extract in Children With Autism Spectrum Disorder. (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Fenix Innovation Group

New P1/2 trial • Autism Spectrum Disorder • Genetic Disorders