In a conversation at CPHI Barcelona, global market development manager Athanasia Kanli and manager marketing communication Céline Zuber explained how the company is tackling this mission.
Some of the substances derived from the cannabis plant are famous for their mind-altering effects - like tetrahydrocannabinol (THC), whose recreational use is illegal in many countries. However, the medical applications of cannabis, particularly those linked to active ingredients in the plant, are gaining increasing interest.
For example, the US Food and Drug Administration (FDA) has greenlit synthetic cannabis-related drug products including dronabinol and nabilone. The agency also made history in 2018 by approving Epidiolex, the first treatment based on purified CBD derived from marijuana. Epidiolex, which is marketed for two rare forms of epilepsy, consists of an oral solution of the non-psychoactive ingredient CBD.
Zuber explained that the emerging CBD market is “developing in a favorable direction” at the moment and there are myriad potential applications, especially in mental health conditions and pain management. Nonetheless, she cautioned that there are multiple challenges for biotech companies developing CBD-based treatments such as difficulties in formulating the compound into solid oral dosage forms, the low bioavailability of the active ingredient, and complex regulations across the globe.
In tandem with partner company Brains Bioceutical, dsm-firmenich is developing a platform to guide biotech and pharma customers through the complex development and manufacturing of their CBD treatment candidate treatments.
“There’s the product but there's also the regulatory expertise, being able to design clinical trials, all the way to scanning the right pathway to enter the market,” said Zuber. “We can facilitate all of that together with Brains Bioceutical.”
Teaming up with Bod Science
One CBD innovator working with dsm-firmenich is the Australian company Bod Science. The companies joined forces last month to fuel the development of what could become the world’s first CBD-based treatment for insomnia.
According to the release, Bod Science is soon due to publish full results from a phase 2b trial of the treatment and deploy dsm-firmenich and Brains Bioceutical’s manufacturing and development expertise to fuel the next stage of commercialization.
Prior to the partnership, Kanli saw Bod Science as a forward-looking company with a strong scientific perspective on the drug development process.
“We were in conversations for a while and then at some point, we got to the conclusion that this was the right partnership for both of us,” she said.
In addition to manufacturing support, dsm-firmenich and Bod Science plan to collaborate in at least two therapeutic areas and grow the partnership towards new formulations and new formats, said Kanli. She added that more information would be released in the coming months.
One obstacle for formulating CBD is that the compound is hard to dissolve in water and is typically delivered in oil or alcohol as soft-gel capsules, a liquid solution, sublingual drops, or an oromucosal spray. In the case of Epidiolex, CBD is mixed in oil and delivered orally via a measuring syringe.
“If you have to administer [CBD] to a child with epilepsy, you might have to give them a tablespoon of oil twice a day,” said Kanli. “I don't want to try to give that to a three-year-old; it's not the most pleasant thing you can do.”
To tackle this challenge, dsm-firmenich is developing a solid CBD formulation that could be delivered in a range of forms including a chewable pill or powder. Compared with current formulations, this formulation could be easier for patients to receive, improve absorption of CBD through the gut and reduce side effects.
“The liver is going to be better, the stomach is going to be better, and there will be fewer drug-drug interactions,” said Kanli, adding that this could also improve patient compliance with dosage regimes.
The company plans to trial the novel formulation in humans next year. While there are other solid CBD formulations in development at other companies, dsm-firmenich was the first to demonstrate improved CBD bioavailability in the solid form, Kanli said.
As dsm-firmenich continues to design and develop new formulations, its mission has become easier with the merger that formed dsm-firmenich this year. The DSM side has all of the formulation expertise whereas the Firmenich side – specializing in flavorings and fragrances – can make CBD products more appealing to patients.
“Let's assume you have a film under the tongue: you want it to taste good, right?” said Kanli. “It's really exciting.”