OMG Pharma Australia (OMG) has entered into a strategic partnership with Swiss-Dutch company dsm-firmenich, which will supply fast-absorbing CBD for an upcoming sleep disorder trial.
The agreement is designed to bring a drug incorporating dsm-firmenich's GMP-certified CBD active pharmaceutical ingredient (API) into OMG's phase III clinical trial targeting insomnia.
OMG noted that dsm-firmenich's CBD is formulated to improve bioavailability and support solid-format medicines that can deliver the required dose in a practical way for patients.
It added: "This is a first-in-class ingredient enabling a first-in-class medicinal product."
A trio of clinical trials will take centre stage for OMG in 2024 as it makes good on its pledge to put patients at the heart of its research and development program.
The company has planned studies on sleep, anxiety, and pain, conducted in collaboration with the NICM Health Research Institute at Western Sydney University and the Medical Research Institute of New Zealand in Wellington.
Led by Emeritus Professor Alan Bensoussan, the research program covers testing of a schedule 3, over-the-counter sublingual CBD tablet for insomnia, a CBD salve for inflammatory conditions, and a sublingual CBD tablet for anxiety.
The double blind, randomised, placebo-controlled S3 trial will enrol 300 insomnia patients, who will receive either a 75mg dose of CBD, 150mg — the maximum permitted under the Therapeutic Goods Administration's down scheduling of the medicine — or a placebo.
Bensoussan said in February that rapid absorption was likely to be central to the trial's outcome, with considerable effort devoted to developing the sublingual tablet.
"A large number of consumers, particularly older consumers, have difficulty swallowing tablets," he said. "A sublingual tablet is a way of addressing that issue.
"It's also a way of achieving more rapid absorption through the oral mucosa. The CBD enters straight into the bloodstream, bypassing liver metabolism. For the purposes of sleep, that's a big positive."
OMG described its partnership with dsm-firmenich as "a shared journey towards excellence in CBD therapy development."
It added: "With a strong foundation in scientific integrity and innovation, this collaboration aims to redefine the standards in cannabinoid pharmaceutical applications, improving patient care globally."
Oz Medicann Group founder John Leith described the collaboration as a "significant milestone in OMG's journey."
He added: "We chose dsm-firmenich as our partner because of our shared vision for science-led, evidence-based solutions — dsm-firmenich is at the forefront of driving innovation in product development and scientific rigour.
"Together, we are not just developing treatments — we are setting new standards for the future of healthcare and patient well-being."
dsm-firmenich is listed on the Euronext Amsterdam stock exchange, operates across nearly 60 countries, and reports revenues exceeding €12 billion.
