Neurotech has received Human Research Ethics Committee approval and TGA clearance to begin a Phase II/III clinical trial of its NTI164 cannabis strain for children with Autism Spectrum Disorder (ASD).
In July, the company announced breakthrough results from a Phase I/II trial of NTI164 conducted at the Monash Children’s Hospital in Melbourne.
The company reported 93% of participants had notable improvements relating to the severity of illness with no serious side effects after 28 days of daily treatment with the strain, which it licenses exclusively from Dolce Cann Global.
Two patients exhibited vast improvement – meaning complete or near remission of all symptoms – while 10 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 anticipated to start in Q4 CY22 and complete in H2 CY23.
Emyria has raised A$3 million in a well-supported placement including follow-on investment from Andrew ‘Twiggy’ Forrest’s Tenmile Ventures and corporate adviser Sixty Two Capital.
The raise will be used to:
- advance the Phase III clinical trial supporting registration and commercialisation activities of EMD-RX5 as an over-the-counter treatment with the TGA
- support the ongoing development of Emyria’s high-dose CBD formulation EMD-RX7
- progress multiple preclinical screening programs for the firm’s novel MDMA-inspired drug discovery program being developed with the University of Western Australia
- fund business development and working capital
Emyria’s directors will participate in the placement to the value of $150,000, subject to shareholder approval.
The final participant enrolled into Cann Group’s Phase III clinical trial investigating the safety and efficacy of Satipharm CBD capsules for treating sleep disturbance has attended their last study visit.
A total of 257 participants took part in the trial, exceeding the company’s initial target of 212, with results expected in early CY23.
Submission of Cann’s formal drug registration application to the Therapeutic Goods Administration will follow soon afterwards.
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 is undertaking a bioavailability/bioequivalence study assessing the pharmacokinetics and tolerability of its cannabinoid combination drug IHL-42X in 116 participants.
The firm said it is well progressed in drafting 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 commence pivotal, multi-site Phase II/III clinical trials investigating the effects of IHL-42X in patients with obstructive sleep apnoea over 12 months.
The Australian Securities and Investment Commission (ASIC) has confirmed Creso Pharma is no longer the subject of an investigation by the body.
In November 2021, Creso was served with a notice under Section 33 of the ASIC Act, requiring it to produce certain documents in connection with an investigation. In August 2022, Creso was served with a further Section 33 notice in connection with the same investigation.
The company said it had complied with both notices, which identified that ASIC was conducting an investigation in relation to persons and entities associated with Everblu Capital and the company, including suspected contraventions of the Corporations Act.
ASIC has now confirmed in writing that the scope of its investigation no longer includes 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 is cooperating with ASIC’s ongoing investigation into trading in Creso Pharma’s securities by external parties.
NZX-listed Greenfern Industries (GFI) saw revenue grow by almost 800% in the six months to September 30, 2022 compared to the previous half-year period.
The company attributed the growth to income generated from the sale of GFI Pharma medicine products in Australia, where sales have climbed month on month.
GFI reported a net loss of NZ$0.85 million for the period, compared to $0.82 million in the previous six months and in line with its forecast. No dividends were declared.
Meanwhile, 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 been 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 has enrolled 60 patients in the US for an Institutional Review Board-approved clinical trial of its cannabinoid medicine for diabetic nerve pain.
The observational multi-arm, head-to-head study will evaluate the efficacy, safety and tolerability of Zelira’s proprietary, patent-protected product with a trial readout 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.”
New Zealand firm Organic Genetics has secured NZ$5m from private investor GCO Pharmaceuticals.
Last year, the company ran a crowdfunding campaign on investment platform PledgeMe to raise $4m to accelerate growth plans including the development of an EU-GMP certified indoor cultivation facility in Auckland.
However, the campaign failed to reach its minimum target of $500k.