BIT (ASX) Ann: Results of Meeting AGM

Originally posted by GiddyYup ↑

Not sure which trial you are referring to with those specific numbers WB but the most recent Hep C trial (008) was a bit of a cluster fork if I recall.

The preliminary results in Sept 2015 revealed that 12 of the 20 G3 participants dosed with BIT225 dropped out. Zero dropouts in the IFN/RBV group. A 60% dropout rate is pretty bad but then it turned out that the non-BIT225 cohort also responded better than the cohort dosed with BIT225 ! Complete shamozzle ......

But that wasn't the entire story. The BIT225 cohort of G3 (the 8 that didn't dropout) actually responded exceptionally well statistically (88% clearance) and not a long way south of the IFN/RBV cohort (90% clearance). It was just that IFN/RBV group responded massively better than the historic norm (68% clearance) making the BIT225 result look bad.

Selling this story was just too difficult for Biotron (mainly because of the massive dropout rate) so they simply never mentioned to G3 cohorts again. In march 2016 when the final numbers came in they reported only the G1 cohort. In this BIT225 excelled with no dropouts and 82% viral clearance vs 60% for IFN/RBV.

As you can see when it came to clearing the virus BIT225 actually did very well in these trials. In fact it statistically did much better with genetype 3 than genetype 1 if you ignore the fact that most of the G3s dropped out. Yes, that inconvenient fact was hard to ignore though.

All in all its apparent that BIT225 was possibly a cure for Hep C however the trial results were tainted by the G3 dropouts and they took so long to get there that a better commercial solution was already headed to market if you recall.

There may also have been a bit of bad luck here. Some of the dropouts likely had nothing to do with BIT225 but most likely did. This was I think the first trial run with the new capsule rather than the powder and they were dosing them with 200mg twice daily (total of 400mg daily). Gut feeling is that the doses of BIT225 were way too high. In fact if we step forward to the following trial (009) which focused on HIV patients, you may recall that there were two groups, those dosed with 200mg and those dosed with 400mg. If you recall some of my previous posts on this Biotron never ever released full results from that trial, and the exciting results released in Sept 2018 only reported the 200mg group. They dropped all the 400mg dosed participants from the published results.

The dropouts in the 008 trial combined with whatever happened to the unreported 400mg participants in the 009 trial seem to have taught them that there were tollerability issues at higher doses. An important part of the discovery process but unfortunately one learned too late to save the Hep C program.

The 009 trial also had other issues which cloud the results. If I recall correctly the baseline numbers for participants fell heavily in favor of BIT225 from the outset. This in my opinion was not by design but a simple statistical imbalance made more likely by the tiny size of the trial, ie # of participants. BIT participants had a higher average viral load to start with. Biotron results presentation appeared to sell the story that those dosed with BIT225 showed a greater fall in viral load. Of course they did. They had more virus to kill from the outset !

I have often said that some of Biotron's problems with trial results were not the outcomes but the anomalies which are a direct result of the tiny size of the trials themselves. The dropout issue with the 008 trial would have been lessened at greater scale and the over achievement of IFN/RBV viral clearance would almost certainly not have occurred to the same extent. The baselines in 009 would likely have been more balanced. This is a recurring theme resulting from the tiny scale of the trials.

Larger trials cost more money so its easy to see why they try and run smaller ones but these were not phase 1 or early phase 2 trials. At some point you have to go hard or go home. They just never did in my opinion. They just kept rolling the dice on small cheap trials hoping for the best.

If you want my opinion BIT225 has clearly shown significant benefit in various combined anti-viral treatments but has little benefit by itself. They have narrowed down the dosage and tollerability to some extent (although not entirely I suspect). They just can't explain the novel action sufficiently to figure out how to position it.

I suspect that BIT225 is a stepping stone to possible new treatments and not the endgame. If they had the time and money to continue pure research into determining exactly how BIT225 works within the body then that would / will enable the formulation of the next gen compound based on that specific knowledge. Biotron and shareholders have however been hoping that the work done so far would be sufficient for BIT225 itself to be taken to market by BP after phase 3. That seems less likely now but I suspect the boards view is that they may have done enough to spark the interest of BP and for them to fund the additional research to formulate the next gen compound on their own. This may be where the consultants come into the picture.

After 24 years the board are discovering that their positions are professional and not academic. Shareholders aren't issuing research grants and the funding for this stream of research is unlikely to continue long enough for the pure research approach to allow them to maybe one day find the holy grail next gen compound, which is what they would otherwise clearly love to do. Had they had a little more foresight and risk management they would have raised cash 6-12 months ago and not driven us all into this cul-de-sac.

Lets just hope that the consultants can find a new home for this research so the benefits of what has been learned may someday benefit many. Lets also hope that key R&D staff get the opportunity to continue this journey if they wish to and long suffering shareholders see some return on their investment (word used loosely).

Expand

So much of what you have interpreted about the HCV trials is completely wrong, but I’m not going to write an essay about it. BIT225 can not cure HCV or HIV - end of.

G3 was an easy fix for Int/Rbv.

The high dose certainly made people sick.

It always has, but they tried to hide it.

They have weaved a wicked web of deception all along in so many ways.

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Ann: Results of Meeting AGM, page-43

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