I like the time you've taken to write out a thesis. I may be wrong, but here are some additional things to consider.
1. Exenatide (Byetta) is already currently used off-label for treating IIH by at least hundreds of doctors around the world.
- Exenatide is specifically formulated only for diabetes control and is therefore adjusted for its diurnal variations. IXC is specifically adjusting the formulation of Exendin to be suitable for the diurnal pressures of IIH.2. I've personally talked to patients who have suffered from IIH, and they can confirm that Exenatide works like nothing else to relieve the intracranial hypertension and associated symptoms. One patient told me they were about to be shunted for the second time, when their doctor put her on Exenatide. She never ended up needing the second shunt, and lives symptom free. However, some have complained that it lowers blood sugar by a considerable amount for non-diabetic patients. - I don't believe this to be correct.
- GLP-1 by their physiological basis, are proven NOT to cause hypoglycemic episodes. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5397288/3. Alexandra Sinclair, the doctor behind Invex, treats patients with IIH every day. Exenatide is quite a common drug, used by hundreds of thousands of patients worldwide. From points 1 and 2, I have a high suspicion that she is one of those doctors who have treated IIH with exenatide, and that was what prompted her to raise $10m, and spend a few years doing rat experiments in order to build up for this trial. She knows it's going to succeed. - Dr. Sinclair seems to be an expert but appears to have run several different trials looking into a variety of different agents over the years.
- The one before this seems to be a drug by the name of 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor which showed some degree of potential in reducing pressure but has not been pursued for some reason. https://academic.oup.com/braincomms/advance-article/doi/10.1093/braincomms/fcz050/5699900Other Points:
- Phase 2B -
It's not a Phase 3, all that's required after this initial study is an additional Phase 2 study that needs to be done in order to be licenced as an orphan drug indication. It needs to be powered and designed in a way that satisfies both UK and US administrators.- "
their patents look to be granted (read the prospectus)" -
they've only got a patent approved in Japan, they still have not got their
- US or UK patents yet.
- Valuation -
I think Exendin will have a larger purposing ability higher than just simply IIH if successful. As discussed previously, it can be trialed in hydrocephalus and Traumatic Brain Injury, both of which involved expensive neurosurgery. The valuation therein, can be several fold higher than any of the valuations discussed on this thread.
Source:
https://www.youtube.com/watch?v=Uh03N6nUJcc&feature=emb_title
