American Marconi Wireless News - Melius MicroBiomics Receives Australian DIR Licence as Key Step Toward Clinical Evaluation

The DIR licence was granted to Melius MicroBiomics Pty Ltd, the Company's wholly owned Australian subsidiary established to conduct regulated clinical activities in Australia. The approval confirms that the OGTR has completed its environmental risk assessment and determined that the therapy may be used safely under defined safety and containment conditions. Receipt of the licence enables Melius to proceed to the next regulatory steps toward first-in-human evaluation.

The Melius therapeutic program builds upon foundational microbiome research conducted in the laboratory of Dr. Deanna Gibson at UBC's Okanagan campus. The intellectual property was licensed from UBC in 2023, a key step to enable translation of this university-led scientific innovation into clinical development. Since then, Melius has further advanced the technology through additional genetic engineering, formulation, and manufacturing optimization, and regulatory preparation to set the stage for first-in-human evaluation.

The Company's lead candidate uses a strain of the probiotic Escherichia coli Nissle 1917 that has been genetically engineered to utilize inflammation-associated metabolites as an energy source, allowing it to thrive in inflammatory environments where conventional probiotic strains lose viability. This design enables therapeutic activity within active intestinal inflammation as demonstrated in preclinical models and supports its investigation as a potential therapeutic approach in ulcerative colitis and other forms of inflammatory bowel disease.

Dr. Kevin Horgan, Head of Research and Development at Melius, added:
"Our team has worked closely with Australian regulators, and the DIR licence demonstrates that our therapy meets the environmental and biosafety requirements for the assessment of genetically modified organisms. We're highly motivated by this milestone and poised to initiate clinical studies to bring this innovative therapy to patients."

"We are very pleased to see the strong progress Melius MicroBiomics has made in advancing the licensed UBC technology toward clinical evaluation, culminating in the receipt of the Australian DIR licence," said Derek Gratz, Associate Director, Innovation at UBC Okanagan. "This important regulatory milestone reflects the team's dedication to translating university research into real-world impact, and we applaud Melius on achieving this significant step forward."

Dr. Deanna Gibson, Non-Exec Chief Scientific Advisor and Co-Founder of Melius, said:
"This marks a major milestone that Melius has been able to achieve in a few short years since the company's inception. I am super proud of the team's achievement, positioning Melius to take the next critical step in initiating human clinical trials with our Australian partners."

With the DIR licence granted, Melius will submit a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA) to support a Phase 1a/1b study evaluating safety and tolerability in healthy volunteers and participants with ulcerative colitis. Clinical development in Australia will be led by Dr. Jakob Begun, Director of Gastroenterology at the Mater Hospital in Brisbane.

Dr. Jakob Begun, Director of Gastroenterology at the Mater Hospital in Brisbane and Principal Investigator for the study, said:
"Microbial therapy has been the holy grail of IBD for decades, but progress in the field has been hampered by a lack of innovative products. Melius has developed a solution to deliver targeted probiotic therapy to treat inflammatory bowel disease, and I am excited to be the lead site for their clinical trial."

About Melius MicroBiomics

Melius MicroBiomics is a biotechnology company developing novel microbiome therapeutics to address unmet medical needs. The therapeutics are based on a proprietary platform for genetically engineering microbes to enhance efficacy and a proprietary formulation technology to optimize gastrointestinal delivery. The Company operates in Canada (Kelowna and Vancouver) and Australia and is advancing engineered microbial therapeutics toward clinical evaluation.

Learn more:
https://www.mmblivebio.com
https://linktr.ee/meliusmicrobiomics

Media Contact:
Leah D'Aloisio
Medical Science Writer
Melius MicroBiomics
[email protected]

SOURCE: Melius Microbiomics

View the original press release on ACCESS Newswire

M.Thompson--AMWN