Eyes, money and renewed interest have poured into the Alzheimer's space in the past seven weeks following the FDA's controversial green light for Biogen's drug Aduhelm. But Annovis Bio thinks the specific interest in its company is due to data on its own AD treatment hopeful, which improves cognition by 30% in 25 days.
The biotech said Wednesday that its oral drug, being tested in both Alzheimer's and Parkinson's disease patients, normalized biomarkers in phase 2a studies. The level of neurotoxic proteins were normalized, meaning they came down, axonal health was restored, inflammation was lowered and neurofilament light was also lowered, said CEO Maria Maccecchini, Ph.D., in an interview with Fierce Biotech.
The data, presented Wednesday night at the 2021 Alzheimer's Association International Conference in Denver, adds to the positive results that the biotech released in May.
Improving cognition
At that time, Annovis said the drug, dubbed ANVS401, improved cognition by 4.4 points for a statistically significant improvement of 30% after 25 days, based on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale 11.
In early June, Annovis also said AD and PD patients in the phase 2a study showed a statistically significant increase of 23% to 28% in correctly coded fields after 25 days of treatment. That was based on the WAIS coding scale, which measures speed, coordination, attention, focus and accuracy, the CEO said.
Berwyn, Pennsylvania-based Annovis expects more data around synaptic markers in the coming weeks and will meet with the FDA in late-September or October to start discussing phase 3 studies, Maccecchini said. The 69-patient phase 2a study is done, with the last patient coming off on Saturday, the CEO added.
'Even remotely as good'
Maccecchini did not mince words when describing how Annovis can compete against the recently approved Aduhelm (aducanumab), which has riddled Biogen with controversies and calls for federal investigations.
"I don’t really feel in any way, shape or form that Aduhelm is even remotely as good as our drug. I mean, there’s just no comparison," Maccecchini said.
Aduhelm showed a 22% improvement over placebo.
"But you have to put that in perspective. Placebo goes down 100%, and Aduhelm goes down 22% less, which means it’s 78% worse than at the beginning of the study," the CEO said.
Annovis' drug works by restoring the information flow so that nerve cells do not die. The company has shown in animals that information flow is restored, Maccecchini said.
"When a nerve cell gets sick, the first thing that happens to it, its information flow is sluggish. So, if the information flow is sluggish, you could understand why people think slower, forget more, walk slower, slur speech, get constipated," Maccecchini said.
Multiple phase 3 studies
With this data in hand, and more expected in the coming months, Annovis will meet with the FDA in late September or October to consider multiple phase 3 studies in both AD and PD patients, Maccecchini said.
The company has enough money for one phase 3 study, but the CEO said she expects Annovis' stock to "go up some" and will need to raise about another $200 million to $250 million to carry out additional studies.
The biotech's stock price has skyrocketed 1,014% in the past six months. The data, however, was seen as mixed and partly confused at best from the market, which drove down Annovis' shares by nearly 36% afterhours Wednesday, and opened up in early, pre-market down more than 2%.
The phase 3 studies will enroll hundreds of patients, including a three to six month short-term study and a two-year chronic study in Alzheimer's patients, as well as one or two studies for Parkinson's patients.
"That will really prove everything. It will prove that we can give it short-term, and it will prove that we can give it forever," Maccecchini said.
Drug cocktail
Following phase 3 studies, Maccecchini said she thinks the drug can be studied in combination with other drugs, noting she was "just chatting" with AC Immune, which has AD and PD treatments in the clinic.
"You know, we should combine our drugs. Every chronic condition is treated with a cocktail. Who says that using Aduhelm alone works? I mean, it works a little bit. OK, fine. But I don’t see any problem coming up with drug cocktails to make it better for different people," Maccecchini said.
The CEO said she's "really happy" with companies like Athira, Cassava, AC Immune and Anavex going after Alzheimer's "with different approaches that are combinable."
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