• Althea enters the Irish medicinal cannabis market
  • Recce Pharma completes Cohort 5 dosing of Phase 1 clinical trial
  • Anatara gets ethics approval to expand its trial eligibility

Althea Group (ASX:AGH) will enter the Irish medicinal cannabis market after regulators approved its cannabis oil product.

The Health Products Regulatory Authority (HPRA) and Ireland’s Minister for Health have approved Althea CBD12:THC10 for prescription and supply in the country.

Althea CBD12:THC10 is a cannabis oil containing 10mg of THC, and 12mg of CBD per 1 ml of oil. It’s made from hybrid Cannabis sativa and C.indica plants, where oil is created through ethanol extraction.

The oil has now become one of a limited number of medicinal cannabis products available for prescription and supply in the Republic of Ireland.

Althea says that as a next step, it will apply for the product to be included in the Primary Care Reimbursement Service, making it free of charge for Irish patents prescribed under the Medicinal Cannabis Access Programme (MCAP).

“Having one of only a limited number of cannabis-based medicines approved for sale in Ireland is a massive advantage for Althea,” says Althea CEO, Joshua Fegan.

“And when combined with our world-class medical education program, we aim to achieve positive and sustainable growth in Ireland over the years to come.”


Althea share price today:


Recce Pharma storms ahead in Phase 1 trial

Recce Pharma (ASX:RCE) reported that Cohort 5 of its Phase I clinical trial of R327 has demonstrated a good safety and tolerability profile among the 10 healthy male subjects dosed at 2,000mg.

Following the results, an Independent Safety Committee has unanimously approved Cohort 6 to commence at 4,000mg, with subjects recruited and dosing now underway.

Recce’s RECCE327 (or R327) Phase I trial is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide’s CMAX clinical trial facility.

R327 is used as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria.

According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.

The study is on track to have all Phase I dosing complete by Q2 2022.


Recce Pharma share price today:


Anatara gets approval to expand its trial scope

Anatara Lifesciences (ASX:ANR) says it has received an ethics approval to expand the eligibility criteria for its Irritable Bowel Syndrome (IBS) trial.

In addition, an ethics committee in Melbourne has also approved the revised protocol for the IBS trial.

The revised protocol has effectively expanded the eligibility of the trial to all IBS subtypes other than IBS-C (constipation subtype).

Globally, there is a high prevalence of digestive disorders requiring relief from both symptoms and the disease process, including irritable bowel syndrome (IBS).

CEO Steve Lydeamore said: “We remain hopeful that there will be no significant change to the anticipated dates for the IBS results, and continue to take actions to deliver the reporting dates for this trial.”

However, Lydeamore flagged a potential delay, sending Anatara’s share price down by 3% today.

“There is, however, a revised timeline for the psychological functioning (3FDC) study with reporting now anticipated in early 2023 rather than late 2022,” he said.


Anatara share price today: