Hi all
I was at this mornings AGM and found it to be incredibly insightful. I have jotted down some points that stuck with me:
I think this comment made by Dr Craven is a very concise message about the direction of Invion.
"I know there are a lot of people here in the room who have a history with cpn10, as you know it has been in a lot of clinical trials, it's been in over 250 patients. We saw an opportunity in lupus, and we've developed the Lupus program here, particularly with an eye to partner this drug. To be clear with the strategy [of Invion moving forward], the clinical trials will be completed this year and the data will be available early next year. We will then finish our program with Cpn10 totally funded by this company. The next steps with Cpn10, will be with a partner, and with that, hopefully bring in some non-diluted capital which will allow us to build the respiratory franchise. The future of Invion really is around the respiratory franchise and the development of the two drugs; Nadalol and Zufurkalast
INV102 Nadalol (Oral)
Dr Glass advised that the results of the Nadalol oral program are pretty much complete and the results will be issued in the next 2-4 weeks. He reiterated that Nadalol is the only drug in the world targeting the airway thus creating a huge potential market. He spoke quite openly about seeing positive results in patients, particularly at higher dosages. When asked if there was still risk that the interim trial results would not be successful, he said that "he would be able to able to answer that more accurately in 2-4 weeks".
He was even more excited about the prospects of inhaled nadalol.
INV103 - Cpn10
Dr Glass and Dr Collier spoke about the intention to use the results of this current Cpn10 trial to partner with a large pharmaceutical company when this current trial is completed at the start of next year.
Apparently they realised right at the beginning of this trial that the low dosages (10 & 30mg) were not going to have an impact on patients (he explained why but I wasn't able to accurately record it so I won't speculate). On the other hand, the safety demonstrated in the interim data was huge positive as it allowed them to get permission from the FDA to increase dosages up to 100mg and also trial on patients with renal impairment.
Regarding potential partners, Dr Glass said "I am thirty-one and zero". when someone asked what that meant, he explained that Invion have been in discussions with 31 large pharmacutical companies over the past 12 months and every one of them has expressed a serious interest in Cpn10, especially now they had approval for the the 100mg dosage for renally impaired patients. He also said that once partnered, there may well be other avenues in the autoimmune field for the drug beyond its use in Lupus which Invion is currently focusing on.
They do not yet have permission to go to the 300mg dosage yet.
If the trial is not successful, Invion will not conduct another Cpn10 trial but instead focus only on the respiratory franchise. On the other hand, he explained that the drug has a very stringent patent which Invion will continue to control.
Really good to hear that the board are in close contact with all regulatory bodies around the world, (especially the FDA) and they are getting advice on what sort of things they are willing to approve and what they will not. For example who is eligible to be in the samples for the drugs, frequency and mode of delivery is most likely to be approved etc. Glass mentioned on multiple occasions that it is essential that there is no doubt in your strategy and that you need to communicate with the authorities and base your studies around their feedback.
DYOR - todays meeting was mine.
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(20min delay)