• Cannabis biotech Bod surges after good clinical trial results
  • Imricor granted US$1.15m award in the US
  • Recce issued trademark registration in Vietnam

 

Bod Science’s CBD-based insomnia drug beats placebo

Cannabis focused biotech Bod Science (ASX:BOD) surged 20% this morning after announcing that its Schedule 3 Clinical Trial CBD 100mg displayed advantage over placebo, supporting its commercialisation plans.

The preliminary top line results showed that CBD 100mg had a statistically significant advantage over placebo, with a p-value of 0.04.

A small p-value (typically ≤ 0.05) indicates strong evidence against the null hypothesis, so you can basically rule out the null hypothesis.

The trial assessed the efficacy of a uniquely developed Schedule 3 (pharmacist only) OTC CBD formulation on symptoms associated with insomnia in 208 participants over eight weeks.

The study design randomised patients to receive daily doses of double-blind study medication of either CBD 50mg, CBD 100mg, or placebo for the eight-week period.

The primary endpoint compares Insomnia Severity Inventory (ISI) scores for each dose compared to placebo. The ISI is a patient questionnaire completed at baseline (before study medication) then at week 4 and week 8.

The primary endpoint analysis on the population showed no statistically significant difference between either CBD dose compared to placebo when tested at the 0.025 statistical significance level.

Safety and tolerability of both CBD doses (50mg and 100mg) was then assessed. Overall, adverse event incidence was similar between both CBD groups and placebo, and no safety concerns were identified.

Bod says the trial completion marks a significant breakthrough for its uniquely formulated Schedule 3 CBD product.

“The singularity of this product is in its soft gel format, utilising a patent protected encapsulation technology,” says Bod CEO, Jo Patterson.

“This presents enormous opportunity both through existing permitted pathways, and through other global markets,” she said.

 

Imricor granted award in North Dakota

Imricor Medical Systems (ASX:IMR)  rose almost 3% this morning after revealing that it has received a grant award of US$1.158 million from the North Dakota Department of Agriculture.

The grant was part of the department’s Bioscience Innovation Grant (BIG) program in which Imricor has received the largest of all 25 awards given.

The company says the funds will be used to support the remaining US approval process, including the VISABL-AFL clinical trial and the subsequent FDA review.

Imricor is a pioneer in developing MRI-compatible products for cardiac catheter ablation procedures, and believes it is the first company in the world to bring commercially viable and safe MRI-compatible products to the cardiac catheter ablation market.

 

Recce gets Vietnam trademark

Recce Pharmaceuticals (ASX:RCE) says it has been issued a trademark registration for RECCE® from the Intellectual Property Office of Vietnam.

The RECCE® mark can be used under Class 5 classification in Vietnam, which covers antibiotics, antibiotics for human use, and pharmaceutical preparations, namely mixed antibiotic preparations.

In 2020, Vietnam’s pharmaceutical market was valued at approximately US$10 billion, doubling in value since 2015; with the projected value reaching US$16.1 billion in 2026.

With newly submitted patents pending in Vietnam, this trademark builds upon Recce’s trademarks already registered in the largest pharmaceutical markets in the world such as the United States, Israel, China, Australia, Japan, Hong Kong and Europe.

 

Share prices today: