Biogen’s aducanumab conditional approval may have been controversial, but Monday’s FDA decision spurs a sort of rebirth in the field of Alzheimer’s disease after a “big hole decade.” there is a possibility.
“Literally, a lock has been opened to raise money,” Alzheon CEO Dr. Martin Tolar said in a groundbreaking post-regulatory interview.
Tolar has learned from experience how difficult it is to raise money as his company over the last decade. Administered The first patient in a phase 3 trial of oral anti-amyloid treatment last week withdrew two initial public offerings (IPOs) for timid investors.
Approximately two years after abandoning the second go-around, a biopharmacy based in Framingham, Massachusetts $ 47 million grant This is to fund Phase 3 research from the National Institute on Aging last August.
Now that Aduhelm is able to enter the market after a decade of “big holes” in the treatment of Alzheimer’s disease, Alzheon hasn’t tried to dig deeper for years, but “now. , This legitimacy is recognized, “so I believe that I can raise a huge amount of money. Science, Tolar said.
“The era of Alzheimer’s disease has arrived,” Tolar said, and Alzheon was “beaten by the phone” from bankers, investors, collaborators, and major pharmaceutical companies. The CEO of a major pharmaceutical company is likely to ask his business development leader, “Where is my drug for Alzheimer’s disease?” Tolar said.
Lack of interest “changes in the blink of an eye” and is likely to spur a surge in activity, Tolar said. For Alzheon, this means starting a roadshow next week and considering “all options” for funding. With a five-year grant covering Phase 3 studies, Alzheon will use the new funding to investigate additional indications, the CEO said.
Capital market movements have already begun.
Acumen Pharmaceuticals, which recently entered Phase 1, applied for an IPO on Wednesday. It’s unclear how Aduhelm’s approval affected Acumen’s application schedule, but it took a long time for the company, which has a 25-year history. Acumen had previously been “dying for 20 years,” Torah said.
“People who might have been waiting for signs that there was a way to the product, probably [Aduhelm’s conditional approval] Doug Cole, managing partner of Flagship Pioneering, who helped launch Denali Therapeutics, a biotechnology for Alzheimer’s disease, said.
“When people are encouraged, more money tends to be available,” Cole said in an interview. The pile of cash is likely to partially lead to “opening up alternative approaches,” Cole said.
Both Cole and Tolar said that clinical trials of other approaches would not be hampered by the introduction of Aduhelm to the market. Aduhelm is the first step and more work is needed to treat Alzheimer’s disease. According to Trar, democratizing Aduhelm and deploying the drug in an accessible way is difficult, and Algiers tablets do not require patients to go to an infusion center and be monitored in the same way. Therefore, there are few hurdles to reach the patient.
“Some patients and their families may see this and say,’Please, over time, take part in another product test to seize your opportunity or contribute to society.’ No, “Cole said. , Other patients can prescribe, so you can choose Aduhelm.
According to Jonathan Behr, a partner of SV Health Investor’s Dementia Discovery Fund (DDF), Biogen’s limited partner among other major pharmaceutical companies, the FDA’s decision to focus on surrogate endpoints in the case of Biogen , May also lead to investor interest. Alector is an example of biotechnology in DDF’s Alzheimer portfolio. The company is looking at AD from the perspective of neuroinflammation and is conducting preclinical, Phase 1 and Phase 2 trials of various programs in addition to other neurodegenerative disease programs.
In another interview, Behr and Cole said other neurodegenerative diseases could also boost cash with approval. Behr pointed out diseases such as Parkinson’s disease, ALS, and frontotemporal dementia.
https://www.fiercebiotech.com/biotech/investor-interest-alzheimer-s-changed-dime-following-fda-s-decision-biogen-s-aducanumab Investor interest in Alzheimer’s disease “changed in an instant” following the FDA’s decision on Biogen’s aducanumab