I've finished taking a position in $IXC. Mainly for my own records, but for the entertainment of HC, here's my thesis.
What is the Problem?- Intracranial Hypertension is a condition by which the pressures in the Ventricles of the brain are elevated. It manifests in many conditions including Idiopathic Intracranial Hypertension, Traumatic Brain Injury, Hydrocephalus and Stroke.
- The problem is that when pressures are raised, there is no medication that has been proven to reduce the pressures in the brain in a safe, well-tolerated way.
What has IXC(Invex Therapeutics)done?
- $IXC has the patents, the rights to Exendin(GLP-1 Analog) and the expertise in a world expert in Intracranial Hypertension. It is used widely in diabetes, with the safety profile being excellent, and with the useful side effect of weight loss.
- It has shown that the use of a GLP-1, Exendin can have a direct effect of the CPe in the brain, essentially reducing CSF secretion, in a dose-dependent, sustained way. In rat models, they showed that when used in states of high pressure, it can work to reduce the pressures in the brain.
- $IXC, is towards the end of it's Phase 2 study into the use of Exendin in humans. The results are planned to be released in the first half of 2020.
What happens if IXC is successful?
- If $IXC is successful in showing that Exendin can reduce intracranial pressures in humans, it will result in a paradigm shift in medicine.
- For the first time, there would be a medical therapy that could reduce intracranial pressures, without invasive measures such as invasive shunts or stents. This would be life-changing for patients with IIH, with a recent Cochrane review from 2015 showing no therapeutic intervention having efficacy in reducing pressures in a well-tolerated way.
- $IXC would then move to a larger study where they would adapt the dosage and administration for exendin for use in humans, using what it would seem, to be the majority of the $12 million dollars that they raised in order to fund this study and the commercialisation of the technology.
- Given the orphan drug status for an effective treatment of IIH, this would be presumably, the only treatment on the market for IIH that had proven benefit with acceptable tolerability standards.
What could this mean long term?
- If the GLP-1 analog, Exendin is accepted as an effective medical therapy to reduce intracranial pressures, the question would quickly become whether other conditions that have raised intracranial pressure as the basis of their pathogenesis could benefit.
- Traumatic Brain Injury is a common condition that due to trauma, there is a raised intracranial pressure that develops. Presumably, exendin, if proven to reduce ICP, could be a useful agent in this. Similar hydrocephalus, is raised ICP and would be a possible research avenue for Exendin.
- Stroke, by the nature of it's condition may have a pathogenesis in raised intracranial pressure, but this mechanism is less clear, and further work should be undertaken.
ConclusionA few years ago, people starting realising that SGTL2 inhibitors not only were useful in diabetes, but also in heart failure. This discovery, has turned SGLT2 inhibitors into one of the leading classes of heart failure therapy in the world.
If $IXC is successful in their long term ambitions, we may one day see the day that S/Cut use Exendin may one day be akin to the use of DVT prophylaxis, but used as prophylaxis to prevent the raised intracranial pressures in 'high risk' individuals. The clinical applicability would be paradigm-shifting, and this little Biotech may well be one of the most exciting stories in the decade.
$IXC is exciting. If the Phase 2 is a flop, it's game over in my opinion. But if it's a success, it will open up a new realm of medicine that will excite scientists and clinicians worldwide.
(20min delay)