ECS Botanics, Althea, InhaleRx and Neurotech International: Latest Corporate Developments

The Cannabis Observer ·
ECS Botanics, Althea, InhaleRx and Neurotech International: Latest Corporate Developments

ECS Botanics is preparing to broaden its medicinal cannabis product range after securing a government manufacturing grant and increasing a funding facility by A$3.4 million.

The $118,000 grant will go toward producing live rosin cartridges for both the company's own brand and white-label offerings.

The additional National Australia Bank capital brings the total available to $4.4m, giving the company "greater flexibility to expand its growing and production facilities without equity dilution, and to boost cannabis production and drive increased sales".

The Asset Finance Facility is separate from an existing, unused NAB working capital allocation of $2m.

Chief executive Nan-Maree Schoerie said the extra financing would allow the business to manufacture live rosin cartridges and support "other growth initiatives".

"In mature markets, vaping medicinal cannabis cartridges has become increasingly popular," she said. "Cartridges reduce exposure to harmful toxins, have less odour, are less irritating to the throat and are more discreet compared to inhaling dried flower.

"As a result, vape cartridges, as opposed to dried flower, are more convenient, healthier and socially acceptable for patients seeking immediate therapeutic benefits."

Althea

Althea has introduced a new flower brand to the Australian market through a partnership with Canadian producer Rocket Factory.

The ASX-listed company will launch two THC products under the Atmos by Althea brand — one with 18% THC and the other with 25%.

“We recognise the growth and demand in this market lies within the mid-THC and high-THC segments and therefore we have targeted the launch of these two flowers within these segments,” Althea said.

The company said it would expand the product range over the coming months.

Althea signed a supply deal with Rocket Factory in May, with chief executive Josh Fegan stating at the time that it would secure a reliable supply of quality dried flower — something he described as frequently lacking across the industry.

He added that the flower market had become "increasingly competitive" across all markets.

InhaleRx

The US Food and Drug Administration (FDA) has placed a temporary suspension on InhaleRx's Investigational New Drug (IND) application for a phase 1 clinical trial of its IRX616a product, which is being developed as a treatment for panic disorder.

InhaleRx filed the IND with the FDA in May for a phase 1 clinical trial of IRX616a — a drug-device product delivering synthetic CBD via inhalation in a fixed dose. The US study is separate from and differently designed than the company's planned phase 1 and 2 trials in Australia.

Darryl Davies

The company said the FDA issued the temporary suspension, known as a "clinical hold", "in order to address certain safety concerns for the purposes of ensuring the highest standards of patient safety".

A clinical hold is a standard regulatory action taken when the FDA identifies potential risks or concerns, or requires further information about a clinical study.

InhaleRx said the FDA had so far provided "only preliminary information" and that a formal letter detailing the modifications and additional information needed to lift the hold is expected within 30 days.

The company added: "Our scientific team will actively prepare a comprehensive response to the FDA's feedback upon receipt of the formal letter and we remain optimistic about the future progress of this IRX616a phase 1 study.

"It is important to note that an IND is not a pre-requisite requirement for phase 1 and 2 clinical trials in Australia. Furthermore, as the suspension applies only to the trial specified in the IND application, the company expects to be able to continue (subject to obtaining local Human Research Ethics Committee approval) with its drug-development plans in Australia, most notably with its plan to conduct a Phase 1 (PK/Safety) trial for IRX616a."

CEO Darryl Davies said: “We are committed to working closely with the FDA to address its concerns swiftly and thoroughly. Despite the study being placed on clinical hold, we have deliberately prepared the IND application in a way that would not adversely affect the planned Australian trials if not approved.

“We remain dedicated to advancing IRX616a and bringing new, effective treatments to patients in need.”

Neurotech International

Associate Professor Carolyn Ellaway

Neurotech has named Associate Professor Carolyn Ellaway as its inaugural chief medical officer.

A Fellow of the Royal Australasia College of Paediatrics and a Clinical Associate Professor at Sydney University, Ellaway holds consulting roles at Westmead and Sydney Children's Hospitals in addition to her private practice.

Her clinical focus is the diagnosis and management of children with genetic disorders, including mitochondrial and lysosomal storage disorders and Rett Syndrome.

Neurotech recently disclosed to the ASX that it had held "productive" discussions with the Therapeutic Goods Administration as it pursues a fast-tracked listing on the Australian Register of Therapeutic Goods for its NTI164 cannabinoid drug candidate.

Ellaway said the firm's clinical and regulatory programs for NTI164 "hold significant potential across a range of paediatric neurological disorders, including Rett Syndrome, where I was the principal investigator on the trial and observed significant improvements in my patients after just 12 weeks of treatment".

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