Neurotech International has received approval from the US Food and Drug Administration (FDA) for a pre-IND meeting to explore its NTI164 cannabis strain as a potential treatment for children with Autism Spectrum Disorder (ASD).
Scheduled for March 15, the meeting will see the FDA offer guidance on Neurotech's chemistry, manufacture and control package, along with non-clinical requirements and the company's proposed developmental program for the drug.
The findings from the meeting are expected to shape Neurotech's planned IND submission to the FDA, which would pave the way for a clinical trial of NTI164 in the United States.
Executive director Dr Thomas Duthy said: "We believe the controls we have put in place for drug product manufacture and the strong evidence of safety and efficacy we have demonstrated in our ASD patients, which now extends beyond 50 weeks of daily treatment with NTI164, will be important considerations for our upcoming meeting."
In November 2022, Neurotech obtained Human Research Ethics Committee approval alongside TGA clearance to proceed with a Phase II/III clinical trial of NTI164, building on breakthrough results from a Phase I/II trial carried out at the Monash Children's Hospital in Melbourne.
Creso Pharma
Creso Pharma's wholly-owned subsidiary Mernova Medicinal has strengthened its foothold in Canada by moving into Manitoba, a push driven by rising demand for its recreational cannabis products.
Manitoba is the sixth province in which Mernova now operates, with roughly 170 retail cannabis stores across the region. Creso said the additional sales revenue is expected to help move the company toward profitability in 2023.
CEO and managing director William Lay added the "major milestone… broadens the group's exposure for recreational cannabis sales to 60% of Canada's provinces and will unlock another revenue-generating opportunity".
Separately, Mernova has secured its largest purchase order to date from the Nova Scotia Liquor Corporation (NSLC), valued at A$350k. That order brings confirmed sales for Q1 2023 to a total of A$738k.
Earlier this month, Mernova announced it would launch seven new products in Canada for distribution through the NSLC.
