Medlab Clinical to confirm NanaBis’ potential as non-opioid pain treatment in phase three trials

Australian biotech Medlab Clinical (ASX: MDC) could be the world’s first drug developer to have a registered cannabis-based medicine that outperforms opioids for cancer-related pain management, should its upcoming phase three trials be successful.

The company aims to develop therapeutic pathways for diagnosed chronic diseases including pain, depression. Its most advanced drug candidate, NanaBis™, is a cannabinoid-based medicine designed to treat cancer-induced bone pain.

The drug has been approved for phase three trials in Australia and the United Kingdom and last week, Medlab announced it had secured IND approval from the US FDA, enabling phase III trials to be undertaken there.

Speaking with Small Caps, Medlab managing director Dr Sean Hall said he is confident the company can prove NanaBis™ as a real-world, viable alternative to opioids for pain management.

He said Medlab’s aim is to get through the phase three trials with “good partners and a very homogenous-type patient group to give a rather binary outcome that shows NanaBis™, as a standalone pharmaceutical agent, can provide better relief than oxycodone, the comparator.”

“The goal is a first fully registered CBD:THC product that has gone head-to-head with an opioid and is shown to be better – and we will clarify [the meaning of] ‘better’ as we move down this program,” Dr Hall added.

Cancer bone pain and current treatments

Cancer-induced bone pain is a neuropathic pain by medical definition and is degenerative in nature.

According to Medlab, it impacts about 700,000 new patients in the US, Australia and Canada each year and the global market for this specific pain management is estimated at about US$1.22 billion (A$1.58 billion) and growing.

Dr Hall describes it as a “sinister” pain that gives patients good days and bad days but generally gets worse over time.

“Medical innovation in intensive therapies has excelled every year. But while survival rates of patients increase, the innovation on the other side of the equation for pain management hasn’t been provided.”

“More and more patients are able to withstand the cancer, but are living longer with pain, and it becomes a slippery slope,” he said.

The World Health Organisation has adopted a three-step model to guide physicians on how to administer pain relief with the intention of reducing exposure to potent opioids.

The first step calls for non-opioid analgesics such as non-steroidal anti-inflammatories, before moving to weak or combined opioids such as codeine and tramadol for moderate pain management, with the final step being stronger opioids such as morphine or oxycodone for severe pain.

“The problem is that patients [with cancer bone pain] will migrate into the opioid category relatively quickly,” Dr Hall said.

He noted medical literature shows some 75% of patients with cancer-induced bone pain believe their pain is not adequately managed.

“That’s critical to note for two reasons: one, there isn’t a cure for this type of pain, there is only management; and two, 75% is a hell of a number for a group that we have gone to great lengths to expand life on,” he said.

Innovative delivery system

A key differentiator of Medlab’s drug candidate NanaBis™ is its delivery system, the company’s patented nanoparticle medicine platform known as NanoCelle™.

The technology delivers nanoparticle-sized molecules of the active pharmaceutical ingredient (API) for absorption across the oral buccal mucosa (the pink fleshy interior of the cheek). In the case of NanaBis™, this is 2.5 milligrams each of CBD and THC delivered as a fine mist spray.

“This is how we can afford to administer very small doses – we get very rapid uptake into the bloodstream and the patient is not ingesting it,” Dr Hall explained.

“For example, if a patient was to swallow a tablet, even with perfect gut and liver function, they would absorb about 10% at best. And that’s before you work out how much of that API actually exists in the tablet.”

So, not only does this delivery method bypass liver, kidney or gastrointestinal upsets that can be side effects of ingestion, it means a lower dose of the API is required.

“The delivery platform can significantly change the safety profile of the patient… and patients on NanaBis™ have [been shown to have] significantly less morphine milliequivalents circulating in their blood at any time compared to opioid takers. This has resonated with regulatory bodies that we have spoken to,” Dr Hall said.

“NanoCelle™ is in a league of its own … We have been through hundreds of patent literature for things that look like, feel like, sound like or smell like something similar. I know in Australia’s case, not one of them was close.”

Trial timeline

Dr Hall said the phase three trials anticipated to start later this year will be shorter and less “laborious” than its previous work, with patients expected to conclude the study within about “17 weeks”.

“Our earlier work has been in many cases fast-tracked either by us or by supportive various departments [in Australia] and abroad. That has shown really strong signals that – as a board, as an executive team, as a bunch of doctors or researchers – has got us terribly excited,” he said.

About 360 patients are planned to be recruited globally, with around a third each coming from Australia, the UK and the US.

“All being well, we anticipate undertaking clinical trials of patients in the northern hemisphere summer,” Dr Hall said.

He said the next steps include co-signing various site agreements for hospitals and ensuring the company has all ticks of approval.

“In the case of the US and the UK, there are some logistics we have to do in order to lawfully get the product in and then, as soon as possible and with the government’s blessing, we will move into each patient’s territory.”

Dr Hall said the company’s goal from a revenue point of view would be securing a big partnering deal with one of the more disciplined multinational pharmaceutical companies and developing a drug that will be a first in class/originator brand.

“As we announce this evidence and we diminish the blue sky around it, it becomes more and more feasible that it’s the right time to start partnering,” he added.