Avecho Biotechnology dosed 244 patients in its phase III insomnia trial, 16% above target, in a development the company said will “strengthen the statistical power” of its upcoming interim analysis.
The ASX-listed firm had originally enrolled 210 patients, but a late flurry saw an additional 34 join the placebo-controlled trial.
Avecho said the larger cohort “will increase the statistical power of the interim analysis and deliver a more robust dataset from which to assess the efficacy of the company’s CBD soft-gel capsule”.
The trial has seen patients receive nightly doses of either 75mg or 150mg of CBD, or a placebo, over an eight-week period, tracking their sleep quality through questionnaires and diaries.
The interim analysis is set to be released in June.
Meanwhile, an independent data monitoring board comprising external clinical and biostatistical experts has been appointed to review the unblinded interim trial data and report its findings to the company.
Avecho stressed that its staff, the trial sites and investigators remain blinded.
Pharmaceutical firm Sandoz last year signed a 10-year development and licensing agreement with Avecho to own commercial rights to the capsule in the Australian market, should it be approved by the Therapeutic Goods Administration.
Avecho retains commercial rights in all international markets “where active discussions with potential partners are ongoing”.
In its quarterly update to the ASX, Avecho report an operating deficit of $887,000 in the three months ending March, and revenue of $184,000.
The company had $4.3m of available cash at the end of the quarter.
Argent BioPharma
Argent Biopharma reported an operating deficit of $788,000 in the third quarter of the financial year, taking its nine-month total to $3.5m.
The company, which completed the 48% acquisition of CannPal Animal Therapeutics earlier this month, said it remains well funded with $16.4m of available cash at the end of the quarter.
The period also saw Argent deliver 1,000 units of its CannEpil drug to Ireland, the firm’s largest commercial shipment with a retail value of around $783,000.
The cannabinoid formulation is designed to manage seizures associated with refractory epilepsy.
“The milestone follows the successful manufacture of CannEpil under EU-GMP standards through the company’s partner, demonstrating Argent’s capability to deliver scaled commercial supply within regulated pharmaceutical frameworks,” it said.
Neurotech International
Neurotech International (NTI) has told the ASX it expects its operating deficit to fall in the first quarter of FY27 as it scales back expenditure on cultivation and preclinical activities.
Responding to ASX questions after revealing it has less than six months’ funding based on its $2.2 million Q3 operating deficit, the company said it will “continue to monitor its funding position and expenditure requirements closely”.
An expected $3.5m tax incentive in Q2 of FY27 will also ease the pressure, it said.
“The company retains flexibility to consider funding initiatives as and when required and will manage its expenditure in line with available funding,” NTI said.
It had $4.4m of available cash at the end of March.
The quarter saw NTI initiate the first site for its Harmony trial exploring the effects of its NTI164 drug on children with autism.
