"NTI has proven in Phase II trials that its product is safer and just as effective as Neuren’s product for treating Rett Syndrome... With $11.6M in the bank and solid clinical data, NTI is ready to find partners that can take its product to the next level."
Neurotech International Ltd (ASX:NTI) is entering a pivotal phase, transitioning from clinical trials to securing strategic partnerships. With positive Phase II results for NTI164 across three neurological disorders, NTI is now well-positioned to seek global partners to advance its product into the US, Europe, and Asia.
As the biotech industry witnesses billion-dollar deals, NTI's progress could lead to significant market opportunities. Read the latest Investment Memo by Next Investors for more info: https://lnkd.in/gSpq9YZK#NeurotechInternational#Biotech#ASX#InvestmentNews#ClinicalTrials#NeurologicalDisorders#NTI164#DealMaking#PharmaPartnerships#OrphanDrug#NTI
NTI164 has successfully reversed immune dysregulation in children with PANDAS/PANS, aligning with the significant clinical improvements seen in our Phase I/II trial at 12 weeks. NTI164 positively modifies immune cell function and gene translation, including the reversal of dysregulated pathways such as MECP2, associated with Rett Syndrome. This discovery highlights NTI164’s potential to normalise immune function and gene translation profiles, offering a promising disease-modifying treatment for PANDAS/PANS.
Additional patent applications have been filed, with genomic analysis underway.
Professor Russell Dale, Professor of Paediatric Neurology, University of Sydney and Children’s Hospital at Westmead and Co-Principal investigator of the NTIPANS1 trial said "My research group hypothesises
PANDAS/PANS is the result of gene-environment (epigenetic) neuroimmune dysregulation leading to persistent or progressive neuroinflammation. Currently most patients are symptomatically managed, whereas NTI164’s anti-neuroinflammatory properties have now been shown to induce important epigenetic and proteomic changes in immune cells collected from patients at baseline (day zero) and after 12 weeks of treatment. This data is exciting as it demonstrates that the biological aspects of this debilitating condition can be modified by NTI164, including immune and epigenetic dysregulation, improving overall health and functional outcomes of children with PANDAS/PANS. We eagerly await further genomic analysis from these same patients.”
Read the full ASX Announcement here: https://lnkd.in/guG3kgfa#NTI164#PANDAS#PANS#Neurotech#NTI#Biotech#ClinicalTrials#ImmuneDysregulation#GeneTranslation#RettSyndrome#PediatricHealth#PharmaInnovation#ASX#OrphanDrugs#Proteomics#GenomicAnalysis#HealthcareOntario Rett Syndrome AssociationPANDAS Network Official-
PANS PANDAS UKPANDAS PPN @pansaustralia @PANDASPANSON @PANDASPPN @PANDASnetwork @PANSPANDASUK
Special Report: Neurotech has submitted a request with the US Food and Drug Administration for orphan drug designation (ODD) for use of its broad-spectrum cannabinoid drug NTI164 in children and adults diagnosed with Rett Syndrome.
Media coverage by Stockheadhttps://lnkd.in/gRxGbR77#rettssyndrome#ASXNews#biotechnews#NTI#neurotech
We've submitted today, a request to the US Food and Drug Administration (FDA) for orphan drug designation for the use of NTI164 in children and adults diagnosed with Rett Syndrome.
If granted, ODD could provide several incentives, including tax credits, exemption from user fees, and seven years of market exclusivity upon approval.
Rett Syndrome is a rare neurological disorder affecting approximately 15,000 girls and women in the US and 350,000 globally, with the global market estimated at over $2 billion annually.
A response from the FDA Office of Orphan Products Development is anticipated within 90 days of filing.
Read the full ASX Announcement here: https://lnkd.in/gNThDbGC#NTI#Neurotech#biotech#RettsSyndrome#NTI164Ontario Rett Syndrome Association
