The US contract manufacturing organisation (CMO) will formulate NB1222 - a synthetic tetrahydrocannabinol (THC) prodrug – into suppositories for use in upcoming clinical trials in cancer patients suffering chemotherapy-induced nausea and vomiting (CINV).
Nemus CEO Brian Murphy told us "Catalent has performed a chemical feasibility assessment related to compatibility of materials. The companies plan to move forward to develop prototype materials and test those for the typical parameters associated with suppository delivery of drug before human exposure."
The work will be carried out by Catalent Softgel Technologies according to division president Aris Gennadios.
Gennadios said: “With the convenience that softgel can offer, combined with a lipid formulation to enhance bioavailability and help assure dose uniformity, we expect Nemus to be well positioned to pursue development of an efficacious drug product.”
The project is the second Catalent has taken on for Nemus.
Last January Nemus announced it had hired the CMO to begin developing a formulation of another CINV candidate called NB2111.
The synthetic cannabinoid candidates are made using an in-vitro synthetic manufacturing method developed by Teewinot Life Sciences.
The technology – which Nemus licensed last year - uses cultured yeast or E.coli cells to produce enzymes called THCA synthase and CBDA synthase that are used to make the drug actives.
At the time Murphy said the approach allows cannabinoids to be made much faster than traditional plant-based production.
"Tweewinot will offer Nemus a strategic and competitive advantage in the cannabinoid therapeutic marketplace by enabling our proprietary THC prodrug and unique CBD derivative molecules to be manufactured in a time-efficient manner” he said.
He also predicted the licensed method will allow Nemus to reduce its manufacturing costs by 60-70% and praised the range of cannabinoids that can be produced.
“We are impressed with the versatility of the biosynthesis system in the ability to produce an array of cannabinoids, which fits plans for our library of cannabinoid pipeline molecules developed with our research and commercialization partner, the University of Mississippi."