Under the services agreement, the unnamed CRO will conduct the double blind, randomized, single-center Phase II trial for AXIM Biotechnologies, Inc.
The goal is to demonstrate the efficacy of Axim’s Gabapentin/CBD chewing gum product in approximately 30 study participants to treat restless leg syndrome (RLS).
“We are working now on the protocol of the preclinical trial and AXIM is working in parallel to finalize the formulation,” Axim CEO George Anastassov, MD, DDS, MBA, told Outsourcing-Pharma.com.
In March, Axim announced it had contracted the global CRO Ora, Inc. to help advance its cannabinoid-based therapeutics.
The company's flagship products include CanChew, a CBD-based controlled release chewing gum, CanChew+, which is undergoing clinical trials in patients with IBS, and MedChew Rx, a combination CBD/THC gum also in clinical trials.