RE:RE:See! I told you so... Good question, G1945V. I have written many times about the potential for a deal between Biogen and Bioasis for the transport of aducanumab (Aduhelm) across the BBB. I've always believed it to be quite unlikely.
It seems to me that there is enough aducanumab getting into the brain to cause problems that may not be adequately offset by efficacy. Getting more in the brain may cause greater problems. Further, venture capitalists have avoided financing new drugs that target amyloid beta for over 10 years. The data hasn't been very compelling with aducanumab (Aduhelm). Its commercial value seems to be limited because so many health insurers, both public and private, are not prepared to cover its use. Biogen's sales of Aduhelm are very low. And there remains great controversy about the FDA's approval of the drug.
One thing that might be interesting is that Biogen in March 2022 will be submitting its protocol for a 4-year Aduhelm Phase 4 clinical trial. Biogen has 9 years from its recent FDA approval to conduct more conclusive studies. This phase 4 announcement may suggest that Biogen wishes to face the efficacy question head on, to complete it at the earliest date possible instead of waiting 9 years. Industry pundits expected Biogen to use up all of the 9 years to extract as much revenue as they can before its efficacy is proven one way or the other.
Does that suggest that Biogen may be willing to more quickly prove Aduhelm one way or the other and, possibly, work on an improved version of Aduhelm (xB3?) in the meantime?
Certainly Biogen's Maha Radhakrishnan, M.D., Biogen's Group SVP and Chief Medical Officer and former board member at Bioasis, is aware of the capabilities of xB3. Could that get Bioasis in the door? A 4 to 5 year preclinical and clinical plan to replace Aduhelm with xB3-Aduhelm could be done with Biogen at some point stating that whether the Aduhelm phase 4 works or not, that the company has a better drug in the works to replace it.
But the thing is, is it worth it to sink more money into amyloid beta? There doesn't seem to be much support for it.
And then, of course, it is possible Bioasis's own xB3-004 could be more efficacious than Aduhelm in slowing the rate of Alzheimer's cognitive decline. I wrote briefly about that in
my xB3-004 article on StoxComm.
Anything's possible. Biogen has been stubborn in its pursuit of getting Aduhelm to the market. Maybe they would try to improve it but it may turn out to be like whipping a dead horse.
And everything I have written here can be summed up by saying, maybe, but I not confident that Biogen will go through another bunch of R&D and clinical trials for a marginal drug. But if Biogen wants to pay for xB3 and the deal doesn't break any other deals and activities in which Bioasis is already engaged, then Bioasis may go for it. But, you know, if xB3-Aduhelm were to fail because of Aduhelm, it may still be a perceived black mark against zB3, undeserved, but still, fake news and weird opinIons seem to rule these days.
Finally, both Biogen and Bioasis may be in possession of data and experience that indicate that xB3 would provide AduheLm with a very great improvement in efficacy and safety. I'm not privy to anything like that. I'll stick with my opinion that Biogen may not want to put any more money into amyloid beta as a target.
But I am certainly interested to see what the capabilities of xB3-004 might be with respect to Alzheimer's. If the rate of cognitive decline could be reduced by a factor of 2 or 3 or more compared to Aduhelm, then it would take 10 or 15 years to reach the point of decline that Aduhelm reaches in only 5 years. Even though xB3-004 would not be addressing the underlying cause of Alzheimer's, it could still result in such a slow decline that it could shape Alzheimer's research and treatment standards in profound ways and be of massive value to Bioasis in the process. And that doesn't even begin to describe the value of xB3-004, the IL-1Ra, interleukin 1 receptor antagonist, that can cross the blood-brain barrier and that may allow the treatment of an untold number of neuroinflammatory and neurodegenerative diseases..
AIMNVHO (All in my never very humble opinion.)
jd