Neurotech International
Neurotech has obtained both Human Research Ethics Committee approval and TGA clearance to proceed with a Phase II/III clinical trial of its NTI164 cannabis strain in children diagnosed with Autism Spectrum Disorder (ASD).
In July, the company announced breakthrough results from a Phase I/II trial of NTI164 carried out at Monash Children's Hospital in Melbourne.
According to the company, 93% of participants showed meaningful reductions in illness severity with no serious side effects following 28 days of daily treatment with the strain, which Neurotech licenses exclusively from Dolce Cann Global.
Two patients experienced vast improvement — defined as complete or near remission of all symptoms — while 10 others showed decided improvement or partial remission of symptoms.
Neurotech executive director Dr Thomas Duthy said the results "provide Neurotech with great confidence to progress NTI164 into a Phase II/III randomised, double-blind, placebo-controlled clinical trial".
He added: "Combined with standard non-drug behavioural therapies, NTI164 can be considered a patient-enabling drug, by improving daily living and allowing children to integrate into society via significant improvements in socialisation and anxiety."
Recruitment of up to 54 patients with ASD is expected to begin in Q4 CY22 and wrap up in H2 CY23.
Emyria
Emyria has completed an A$3 million placement that drew strong support, including follow-on investment from Andrew 'Twiggy' Forrest's Tenmile Ventures and corporate adviser Sixty Two Capital.
The funds will be directed toward:
- advancing the Phase III clinical trial supporting registration and commercialisation activities of EMD-RX5 as an over-the-counter treatment with the TGA
- supporting the continued development of Emyria's high-dose CBD formulation EMD-RX7
- progressing multiple preclinical screening programs for the firm's novel MDMA-inspired drug discovery program being developed with the University of Western Australia
- funding business development and working capital
Emyria's directors will take part in the placement to the value of $150,000, subject to shareholder approval.
Cann Group
The last participant enrolled in Cann Group's Phase III clinical trial examining the safety and efficacy of Satipharm CBD capsules for sleep disturbance has now completed their final study visit.
A total of 257 participants took part in the trial, surpassing the company's original target of 212, with results anticipated in early CY23.
Cann's formal drug registration application to the Therapeutic Goods Administration is set to follow shortly after.
CEO Peter Crock said: "This is a great achievement as part of our over-the-counter CBD strategy, and shows how quickly we are working towards a definitive outcome."
Incannex Healthcare
Incannex is conducting a bioavailability/bioequivalence study to assess the pharmacokinetics and tolerability of its cannabinoid combination drug IHL-42X across 116 participants.
The company said it is well advanced in preparing an Investigational New Drug (IND) Application for submission to the US Food and Drug Administration in Q1 2023.
Once the IND is open, Incannex will begin pivotal, multi-site Phase II/III clinical trials examining the effects of IHL-42X in patients with obstructive sleep apnoea over a 12-month period.
Creso Pharma
The Australian Securities and Investment Commission (ASIC) has notified Creso Pharma in writing that the company is no longer part of its investigation.
In November 2021, Creso received a notice under Section 33 of the ASIC Act requiring it to hand over certain documents related to an investigation. A further Section 33 notice connected to the same investigation was served in August 2022.
The company said it had complied with both notices, which indicated that ASIC was investigating persons and entities linked to Everblu Capital and the company, including suspected contraventions of the Corporations Act.
ASIC has since confirmed in writing that the scope of its investigation no longer covers any suspected contraventions by Creso. It also confirmed that directors Boaz Wachtel and Dr James Ellingford and CFO Chris Grundy are not persons of interest in its investigation.
Creso said it continues to cooperate with ASIC's ongoing investigation into trading in Creso Pharma's securities by external parties.
Greenfern Industries
NZX-listed Greenfern Industries (GFI) recorded revenue growth of nearly 800% in the six months to September 30, 2022 when compared with the prior half-year period.
The company attributed the increase to income from the sale of GFI Pharma medicine products in Australia, where sales have grown month on month.
GFI posted a net loss of NZ$0.85 million for the period, compared with $0.82 million in the previous six months and consistent with its forecast. No dividends were declared.
Separately, Taranaki-based entrepreneur and property developer Philip Brown has been appointed chairman of the company, replacing Brent King who stepped down in October.
Brown holds a significant shareholding in GFI and has served as an independent non-executive director since July 2021.
He said: "I am extremely pleased to… lead the next phase of Greenfern in our pursuit of becoming a leading global grower and exporter of cannabis flower and therapeutic medicinal products that will enhance the availability of alternative health and well-being outcomes.
"I look forward to taking Greenfern to the world and working at the business coal face of this exciting industry."
Zelira Therapeutics
Zelira Therapeutics has enrolled 60 patients in the United States for an Institutional Review Board-approved clinical trial of its cannabinoid medicine targeting diabetic nerve pain.
The observational multi-arm, head-to-head study will assess the efficacy, safety and tolerability of Zelira's proprietary, patent-protected product, with trial results expected in Q1 2023.
CEO and managing director Dr Oludare Odumosu said: "A positive result on one or more [study] endpoints would be a landmark event for our company and in line with our value-creation strategy of generating scientifically rigorous, clinically validated data for our patent-protected, proprietary cannabinoid-based drugs.
"Above all, positive results will validate the real potential for creating safer and efficacious cannabinoid medicines for the treatment of diabetic nerve pain."
Organic Genetics
New Zealand company Organic Genetics has secured NZ$5m from private investor GCO Pharmaceuticals.
Last year, the company ran a crowdfunding campaign on investment platform PledgeMe seeking to raise $4m to accelerate growth plans, including the development of an EU-GMP certified indoor cultivation facility in Auckland.
That campaign did not reach its minimum target of $500k.
