Medlab Clinical (ASX: MDC) has collared clinical investigational new drug status from the United States Food and Drug Administration for its lead candidate NanaBis, which is designed for treating cancer-related pain.
IND status from the FDA paves the way for the cannabis-based NanaBis formulation to be used in a phase III trial in the US – joining the UK and Australia as approved trial jurisdictions.
The phase III trial will evaluate NanaBis as a monotherapy for metastatic cancer-induced bone pain, which is the most common cancer pain. The drug will be delivered via Medlab’s proprietary NanoCelle technology.
“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,” Medlab managing director Dr Sean Hall said.
“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,” Dr Hall added.
As well as seeking clinical IND approval from the FDA, Medlab has also applied for expanded access. If the FDA grants approval for expanded access, it will enable Medlab to begin selling NanaBis in the US under compassionate use guidelines.
According to Medlab, the current treatment for cancer-related bone pain is opioids, which can be ineffective in many cases.
Medlab claims there is a “high unmet need” for non-opioid alternatives for treating cancer-related pain in a safer and more effective manner, with 64% of all bone cancer patients not helped by existing therapies.
Underpinning IND approval was Medlab’s data from its phase I/II trial which was completed in March last year.
The IND application also included results from Medlab’s real world observational study which is showing a 55% reduction in pain with NanaBis along with improved quality of life outcomes.
NanaBis is made of a one-to-one ration of CBD and THC, with 2.5mg of each compound delivered via the nanoparticle NanoCelle platform.
Medlab’s claims the NanoCelle platform improves bioavailability and absorption.
It is estimated the cancer-related bone pain market is worth about US$1.22 billion globally, with 700,000 new patients annually in the US, Australia and Canada alone.