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Invex Therapeutics - What is all the fuss?

Samso seeks to help clients with business development and public investor/relation needs. Samso has more than 30 years of experience in developing business ideas and concepts in the Australasian region.

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There is no approved drug to treat Idiopathic Intracranial Hypertension

On July 5 a friend told me about this great stock called Invex Therapeutics Ltd (ASX:IXC), that ran from an IPO price of $0.40 to a close of $1.08. As always, I was intrigued.

After some research, I found out that it’s a biotech stock with the famous Andrew Forrest as a significant shareholder.

As we all know, sometimes stocks run via association with a high-profile investor, but I wanted to find out what got Mr Forrest interested enough to put his hard-earned money into this Company. I am assuming that he had done his research.

According to the company presentation, the business is repurposing a drug called Exenatide for neurological conditions involving raised intracranial pressure such as Idiopathic Intracranial Hypertension(IIH).

The biotech space has numerous 'wonder drugs' that end up in tears, and I wonder if this is another one of those. When the stock price rose so spectacularly, I began to wonder and decided to do some Samso research.

I know that the most likely case for the run is the 'Twiggy' factor, but I was more interested in why the Twiggy Factor featured in this story. We all know that the price will eventually run out of steam. However, if there is a good story, that will carry more weight.

Photo by Aiony Haust on Unsplash.

What is the 'Cure' of the story?

Idiopathic Intracranial Hypertension or IIH is a severe headache caused by increased pressure around the brain that can lead to blindness. There is no detectable cause.

The main symptoms are a headache, vision problems, ringing in the ears with the heartbeat, and shoulder pain. Complications may include vision loss.

The current understanding of population risk is diet. It appears that people who fit into the obese category are most at risk.

According to Wikipedia, about two per 100,000 people are newly affected per year, and the condition most commonly affects women aged 20–50.  Women are about 20 times more likely to be affected by the disease than men. IIH was first described in 1897.

I know that I am making light of the symptoms and I do realise that the condition is more than a severe headache. It’s like my sister-in-law telling my wife that contraction pain is just like bad period pain. How wrong was that and silly for my wife to take advice from someone who had not given birth to a child yet. The company's strategy is to develop a 'cure' that will make a significant change.

The company

Invex Therapeutics Ltd is a biopharmaceutical company focused on the treatment of neurological conditions derived from or involving raised intracranial pressure, such as Idiopathic Intracranial Hypertension, acute stroke and traumatic brain injury.

The research is backed by the University of Birmingham, UK, by Dr Alexandra J Sinclair. Dr Sinclair, who will be the chief scientific officer of IXC, is a clinician and global leader in the treatment and pathophysiology of IIH.

The concept surrounds a drug called Exenatide. This is a drug that has already been approved for therapeutic use in humans by the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA) for the treatment of type II diabetes, and can reduce intracranial pressure.

Exenatide is a glucagon-like peptide-1 receptor agonist first approved in 2005 for the treatment of type II diabetes.

IIH is a condition of unknown cause but associated with obesity, younger age and females. IIH results in raised pressure in the brain and can cause daily headaches and loss of sight by compressing the nerves supplying the eye (papilloedema).

Photo by Louis Reed on Unsplash.

Dr Sinclair demonstrated in animal models that Exenatide, given subcutaneously (under the skin), had been able to reduce intracranial pressure by reducing the cerebral spinal fluid secretion via action on the choroid plexus, in a dose-dependent manner.

Currently, Phase II Proof of Concept Study is now underway exploring the possibility of reducing intracranial pressure in patients with IIH.  Results of this study are expected to be completed in the first half of 2020.

The company will receive the rights to patents on the applications of Exenatide for both the European Union and the United States after the IPO. At this stage, the company will also be acquiring the relevant Intellectual Property from The University of Birmingham.

Management of the company looks well-credentialed,

  • Dr Jason Loveridge, chairman – Experienced life science investor and CEO;
  • Prof Alexandra Sinclair, executive director and chief scientific officer - Global scientific and clinical leader in IIH;
  • David McAuliffe, non-executive director - Founder of numerous life science companies; and
  • Narelle Warren, non-executive director and company secretary – Expertise in finance and compliance.

Corporate information

Market capitalisation: $64.63 million (ASX)

Outstanding shares: 55 million (ASX)

Top 20 shareholding: 80.06% (ASX)

Share price chart of Invex Therapeutics Ltd as of July 12, 2019. (Source: Commsec)

There is no need to comment on the share price chart. I am assuming that the steam is running out and the market is now coming back to a point where it is figuring out what to do.

Whether the price will continue to rise or go back to a more realistic price range, only time will tell.

Repurposing approved drugs – an established, successful business model

The concept of repurposing approved drugs is not a new thing. It has been happening for decades. I liken this issue of repurposing to taking these 'purpose-made' drugs with their 'side-effects' and making them useful in treating other problems.

One such product is Thalidomide. Thalidomide was first promoted to help with sleeping disorders in the late 1950s. First introduced and made accessible in Germany, Thalidomide became over the counter and was as commonly used as aspirin.

Around the 1960s, Australian obstetrician Dr William McBride discovered that the drug alleviated morning sickness. He started recommending that this was a great drug for his pregnant patients.

The result was that this drug caused severe congenital disabilities. The drug inhibited the healthy development of babies, causing many of them to be born with shortened, deformed or absent limbs.

Repurposing approved drugs – An established business model.

Now, decades later, thalidomide is being used to treat a skin condition and cancer. It’s being investigated as a treatment for many other disorders. The concept was that instead of inhibiting human tissue growth, it could help inhibit the growth of cancerous cells.

According to an online medical site, Mayo Clinic, research into potential uses for thalidomide has determined that thalidomide may be an effective treatment for several conditions. The Food and Drug Administration (FDA) has approved thalidomide (Thalomid) for treating:

  • Skin lesions caused by leprosy (erythema nodosum leprosum)
  • Multiple myelomas

Thalidomide has shown promise in treating:

  • Inflammatory diseases that affect the skin, such as cutaneous lupus and Behcet’s disease
  • HIV-related mouth and throat ulcers, as well as HIV-related weight loss and body wasting
  • Cancer, including blood and bone marrow cancers, such as leukaemia and myelofibrosis, as well as cancers found elsewhere in the body

The same issue of restricting growth in human development is being used to limit the growth of cancer cells. This is the theory of repurposing drugs for other causes.

The significance of what Invex is doing with Exenatide

As I mentioned earlier, Exenatide is a drug being used to help people with Type II diabetes. I do not profess to know these biomedical terms and facts other than what I read from my research. My research does tell me that Exenatide is an accepted product for its intended treatment of Type II diabetes. As mentioned, I am trying to figure out why or at least what is the attraction to the science behind the spectacular share price movements.

What Invex is saying in terms of its strategy is that they have the technology and the Intellectual Property to repurpose Exenatide. Invex will be the first mover in this sector and this will give them a great advantage.

In my fact-finding mission, I noticed this profile of Dr Sinclair on the website of The University of Birmingham:

"Dr Sinclair now works as a Clinician Scientist with a role combining clinical neurology with translational research into idiopathic intracranial hypertension and the neuroendocrine aspects of headache.

Dr Sinclair and her research group recently hosted a high-profile visit from NASA. NASA is interested in Dr Sinclair’s expertise on raised Intracranial pressure stemming from her leading Idiopathic Intracranial Hypertension clinical service at University Hospital, Birmingham, coupled with her translational science portfolio at the University of Birmingham.

Her recent discovery of the novel use of Glucogon-like peptide 1 receptor agonists to reduce intracranial pressure are of particular interest to the NASA team in their quest to reduce brain pressure during long duration space travel and allow them to go beyond the Moon.

The NASA visitors were: Dr JD Polk, chief health and medical officer; Dr Terrance Taddeo, Johnson Space Centre chief medical officer; Dr Mike Barratt, physician and astronaut; Dr Victor Schneider, physician liaison to the NASA Human Research Program and Dr John Allen, audiologist and member of the Human Exploration. As part of the visit Dr JD Polk gave a sold-out keynote talk."

My thoughts

What troubles me the most is that I cannot understand the importance of IIH to commerce. I do not know why commerce is interested in a condition that is not spectacular in the number of patients. After all, according to the research out in the Google world, the consensus is that the 'cure' to IIH is diet.

Looking closely at the presentation, I finally saw the key to this business. There is no approved drug to treat this condition. This is the problem with the presentation that is posted on the internet. There is no audio to tell us the key points. If there is video or audio available, it is not freely available or easily searchable.

In the keynote speech by Dr JD Polk at The University of Birmingham, I got two hints on where the demand may be coming from in terms of the fascination from commerce.

Firstly, Dr Sinclair mentioned that the health system in the UK is experiencing an increase in incidents. That would mean that there is a real need to seek a solution. Like all statistics, if the numbers are at a stage of being mentioned in the UK, it would be the same in other regions of the world. The one thing we know about health conditions is that it is agnostic of race, religion or any other separations.

The second point was that the NASA medical team talked about how the weightless nature of space causes intracranial pressure and they affect the astronauts in the same ways to those on earth. These are people who are not obese and are at peak health who are experiencing intracranial pressure.

With this in mind, I feel that this is like a lot of health conditions that are not in the spotlight but are common in the medical world, such as the medical conditions, adrenoleukodystrophy (ALD), which is made famous by the movie Lorenzo’s Oil. There were not that many people diagnosed with the state but the discovery of Lorenzo’s Oil made a world of difference to the patients.

The fact is that the discovery of Lorenzo’s Oil made that condition treatable. The discovery of a way forward to treat IIH would give existing sufferers of this condition a way to be treated.

Conclusions

Irrespective of the share price, I am very interested to know more about this strategy. Biotech stories tend to be a hit and miss.

The risks are very similar to a mineral explorer looking for the motherlode.

I don’t mean to make light of this story, especially when I don’t feel that I am fully informed, but the historical journey of biotech stocks has not been the best. There have, however, been some spectacular winning stories too.

What we all know at this point is that the spectacular share price movement has made a lot of investors happy and as they say, Happy Shareholders, Happy Company.

I will be keeping an eye on the story and hopefully, I can convince the management to meet and have a Coffee with Samso to discuss what I feel is a fascinating story.

www.samso.com.au

Samso is primarily a consulting company that delivers digital information to the market in terms of creating organic content.
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Samso has nearly 30 years of experience in developing business ideas and concepts in the Australasian region.
Samso has worked primarily in the mineral resources industry, capital markets and corporate finance. Noel Ong is the founder of Samso.

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