Medlab Clinical has been granted clinical investigational new drug (IND) status by the US Food and Drug Administration (FDA) for cancer-related pain treatment NanaBis.
The move allows Medlab to initiate a Phase III trial in the US, joining the UK and Australia as approved Phase III trial jurisdictions.
NanaBis is a CBD/THC formulation optimised by proprietary delivery platform, NanoCelle. The Phase III trial will investigate NanaBis as a monotherapy for metastatic cancer-induced bone pain, the most common type of cancer pain.
NanaBis is the only cannabinoid-based pharmaceutical currently under development for cancer pain initiating Phase III trials in the US.
The standard treatment for cancer-related bone pain includes opioids, which have shown to be ineffective in many cases. Medlab said there is a high unmet need for a non-opioid pain alternative that is safer and more effective.
The IND grant submission to the FDA includes data generated from the company’s Phase I/II trial completed in March 2020 along with supporting data from Medlab’s real-world observational study, which shows a 55% reduction in pain together with improved quality of life outcomes.
Medlab said in the coming months it expects the Drug Enforcement Administration (DEA) to approve NanaBis for shipping to the US in preparation for the trial to begin, followed by the introduction of NanaBis into the US market.
Medlab Clinical managing director Dr Sean Hall said: “Receiving clinical IND status is a major milestone for our NanaBis program and a recognition of the robust clinical and real-world data backing NanaBis for cancer bone pain.
“We have now received clearance in the US, UK and Australia to commence clinical entry and are making preparations for study initiation later this year. A successful Phase III trial could see NanaBis as the first cannabis-based pharmaceutical containing THC in the US.”
The company has made a second IND submission for expanded access which, if successful, will enable compassionate use sales in the US to commence.