OMG Pharma Australia (OMG) has announced a strategic partnership with Swiss-Dutch firm dsm-firmenich including the supply of fast-absorption CBD for its forthcoming sleep trial.
The collaboration seeks to introduce a drug featuring dsmfirmenich’s GMP-certified CBD active pharmaceutical ingredient (API) to OMG’s phase III clinical trial for insomnia.
OMG said dsm-firmenich’s CBD is formulated to enhance bioavailability and enable solid-format medicines that meet the required dose in a convenient 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 is planning studies focused on sleep, anxiety, and pain in partnership with the NICM Health Research Institute at Western Sydney University and the Medical Research Institute of New Zealand in Wellington.
Under the guidance of Emeritus Professor Alan Bensoussan, the program includes testing 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 see 300 insomnia patients administered either a 75mg dose of CBD, 150mg – the maximum allowed under the Therapeutic Goods Administration’s down scheduling of the medicine – or a placebo.
Bensoussan told Cannabiz in February that fast absorption was likely to be key to the trial’s success, with significant work going into the development of 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 said the partnership with dsm-firmenich represents “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.”
Listed on the Euronext Amsterdam stock exchange, dsm-firmenich has operations in almost 60 countries and revenues of more than €12 billion.
