If we want to talk about what you do, we first have to answer a short but complex question - what is pain?
Everybody knows pain. We all experience it at some point in our lives, be it in the most or least extreme of its manifestations. A young child quickly learns what hurts and to avoid it; an older person can experience joint pain as an example. What we are learning, though, is that there are multiple variations of pain, and different reasons for it, too. Therefore, to treat pain, one should know which ‘sub-category’ of pain they are dealing with, and consequently use drugs that are specific to when and how that pain is being manifested in the patient's body. Until now, the drugs being developed did not take these factors into account, acting as a ‘sledgehammer’.
We, on the other hand, are trying to tailor a medication for the specific type of pain that people are suffering.
When you say ‘sledgehammer’, are you referring to the opioids market?
Correct. Opioids are very powerful drugs, but not necessarily useful in all types of pain. It is rather shocking to think that for all the advancements medicine has experienced in the past 30 years, we have not seen a significant change in the types of medications that we use for treating various types of pain associated ailments. Opioids have been around since the early 1800s, and they are still what we always use for severe pain for patients post-surgery. They are useful and necessary, but not in all painful conditions.
The problem is that some people have the best day of their lives when they are exposed to opioids, leading to addiction, while others experience problems such as confusion, suppression of their respiratory system, nausea or drop in blood pressure. With chronic pain situations some patients choose to suffer the pain rather than the side effects of opioids.
How is Halneuron® different from other pain medications?
Halneuron® is a different approach to pain because it works on the peripheral nervous system.
Almost all other drugs for pain have a central effect; they work on your brain to modify how nerves communicate in the brain but at the same time it activates or interferes with other brain functions. This does not happen with Halneuron because the drug does not cross the blood-brain barrier, hence avoiding side effects such as somnolence or change in mood, and very importantly, avoiding addiction. Halneuron blocks the signal from moving from the source of the pain to the brain. And without it getting transmitted, the brain has nothing to interpret, much like the analogy about the tree falling in the forest without anyone there to hear it.
We are targeting a sodium channel on the periphery which is Nav1.7. Without any question, the scientific literature is replete with evidence asserting that blocking Nav 1.7 affects the sensation of pain. We know this because some humans can have mutations in their Nav1.7 so the channel opens more easily and stays open longer which lead to an increased stream of signals to the brain, perceived as pain, even though there is no stimulus - as happens for example in erythromelalgia. Other mutations with non-functional Nav 1.7 results in a total loss of pain sensation. Hence, what we try to do is to dampen pain by targeting the Nav1.7 sodium channel.
What are some of the challenges present in clinical trials for a drug that tries to deal with pain?
Testing drugs for almost all conditions is based on irrefutable and objective data. When it comes to pain trials, we are faced with having patients answer a questionnaire with a certain scale, but you are dependent on the patient’s subjective answer, and this brings about all sorts of problems. Another challenge when it comes to pain in clinical trials is the placebo effect - when patients expect to get better, a certain percentage (and this percentage can be 30-40%) will respond that they got better regardless of what you treat them with. These are major hurdles we are facing - trying to transform the subjective into objective and trying to get true results.
How efficient does Halneuron appear to be in treating Chemotherapy Induced Neuropathic Pain (CINP) and how are approval processes mirroring that?
We carried out a phase 3 clinical trial in patients with cancer related pain. These were late-stage cancer patients that already had optimized their opioid and co-analgesic treatments - in other words, the doctor had thrown everything possible at them to try and reduce the pain, and it was not working. A statistically significant number of patients that received Halneuron, at 8 and 30 days after treatment, experienced a reduction of 30% or more in their pain - and these were the worst case patients.
We are now conducting a phase 2 trial with patients that have developed neuropathies but are trying to resume their normal lives, and we are confident that the results will be even better. Health Canada and the FDA have also reviewed a phase 3 clinical program and have approved it to move forward. More importantly, we applied for a SPA (Special Protocol Assessment), where the FDA scrutinizes in greater detail, and if the trial is successful, they will consider it as pivotal, and it can be use as one of two trials for drug approval. Based on data to date - we believe Halneuron has a bright future ahead.
