Landscape of A2-73 competition
Neurotrope's Byrostatin1 top line results of 150 participant ph2 clinical trial are due in April 2017.
(This is a 15 week study. Clinicaltrials.gov)
Axovant's AZ drug, interpirdine, expects results from its 1150 participant ph3 trial due in October 2017 (ibid).
(This is a 24 week study. MOA/classification 5-HT6 drug. Previous 5-HT6 drug trial by Lundbeck Pharma for idalopirdine was halted when it was obvious it would not meet endpoints, and from overdosing which caused 21% dropout rate. Axovant is trying to dial the dose down but maintain some efficacy although some conclude it's the drug's MOA that is flawed, not the trial.)
Beyond these, Biogen will report sometime in late 2019 for prodromal and mild AZ, and other BP's also still glued to beta/Amyloid "mabs" will report much further beyond the horizon.
Anavex's 15 month results on A2-73 due at the end of March is the lead off hitter.
Assuming we make it on base (no safety issues, 15 month stabilization, and ph3 still a greenlight), the pressure seems to be on those in the on deck circle, no?
Either or both of our competitors would have to show equal or greater safety ALONG WITH longer stabilization (not possible - these are shorter trials), or disease reversal or statistically significant patient improvement over baseline and placebo (again for shorter period of time, although larger sample, but safety/efficacy issues in prior H-TP6 study).
I consider stabilization over 15 months to be equivalent to getting to first base on a walk. We get to first base safely. If next two batters cannot hit safely (show statistical improvement without adverse effects) even stabilization for a shorter time period would be considered a walk, imo, and advance our runner into scoring position. Anything less, would be a strike out or put out, imo.
That being the case, if Missling is the manager and knows we have a lead off single (not more than that due to small size), why not take our base and wait to see what the next two batters put up (we don't even have to take a lead off the bag and risk a pick off, just wait, it's a good call). No one on deck is in a position to hit a HR at these early phases, imo. So, why not wait to see if we are the only runner left on base? If so, that sure makes BP's acquisition decision easy, I think. Also, if acquired, wouldn't we come with a signing bonus as in govt funding? Our presence in Australia and Europe (Germany), would be exactly the pressure/leverage this administration needs to "Win at home", "Put America first" cut healthcare costs (AD is killing us financially) and demonstrate the managerial prowess it would like to be recognized for. Can you imagine a leader promising "we have all the best things in our country" and "we will bring jobs back" and "we will win at trade", losing the entire silver tsunami market to another country?
And, if that doesn't sound convincing (CEO's knowing that this admin wants to win on our soil) here is something I found interesting while researching our competitors:
Axovant Sciences GmbH: In August 2016 Axovant Sciences GmbH was incorporated in Switzerland by the company. Axovant Sciences GmbH recently opened its office in Basel, Switzerland and is in the process of hiring employees to lead key functions. Axovant Sciences GmbH is expected to be the principal operating company for conducting Axovant's business and the entity that will hold Axovant's intellectual property rights.
Note: Anavex registered as a GmbH in Munich, Germany in June 2016.
So, we either win at home, with federal help, or we win one on the road. Ouch!, for the hometown fans, always, imo, but a win's a win.
Bottom line: the table is set if we get on base with our 15 month results, manager waits to see what our competition puts up, we could advance on a balk, wild pitch, couple of K's, ground into double play, or stay ahead of the next two runners and be in scoring position. Then we load the bases in our ph3 trial and that's when we hit the walk off grand slam.
Clear the deck, cannonball coming. (And in our bull pen: Retts, Parkinson's, MS, insomnia, depression...A3-71, and others.)
We could win the pennant:)
Seriously, I think there is something to be gained from the so-called "last man standing" theory. It doesn't guarantee that our ph3 will succeed, but it would guarantee that we have a ph3 and that it would get some "last resort" funding, along with the much needed media attention at last. After all, when there's nothing else to cover and you have to sell stories and hope/hype and AD is the talk of the town, do you choose to continue to eulogize past treatments, talk about the possibilities to come currently out of reach, or do you exploit the rising star - even if it's only the star du jour?
I'd be surprised if the Rett trial were to begin before August. It will be designed and protocol set forth and enrollment can begin throughout the summer, these would all be positive intermittent PR's. But if we begin a 12 wk trial which could end before Axovant reports their results, then we stand a chance to fail before they fail (different indication but won't matter). OTOH, if Axovant reports positive results in October and we follow up with a positive Rett outcome/approval, we steal their thunder and limelight. We also remain positioned to partner, acquire govt financing for ph3 AD due to boosted confidence, as well as continued stabilization of current cohort. That HAS to help us. And if Parkinson's is warming up in the bull pen... fans would go crazy.
If, Axovant results fail, similar to Lundbeck, then, "the price of poker just got higher" for $AVXL.
We've shown our cards for this round. 15 month stable and counting. Call, raise, beat, or fold. (Cue the post A2-73 15 mon results bash articles, which is a good thing, because that is called bluffing - won't win this game. Only time you bluff, is when you have...nothing.) Doc M is waiting for the others to show us their cards, imo. We aren't bluffing!
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