Shares of Annovis Bio, Inc. (ANVS) are on a roll Friday, following new results from a phase IIa trial evaluating lead drug candidate ANVS401 in early Alzheimer’s disease and Parkinson’s disease patients.
In March of this year, the company reported interim data of the first 14 Parkinson’s disease patients, demonstrating that speed and coordination scores both improved following 25 days of ANVS401 treatment, with no serious adverse events.
What’s driving the stock up today?
According to the trial results reported today, 14 Alzheimer’s disease patients showed statistically significant cognitive improvement as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11), following 25 days of treatment with ANVS401.
The ADAS-Cog11 improved by 4.4 points in the ANVS401-treated group from baseline to 25 days, a statistically significant improvement of 30%. When compared to placebo group at 25 days, the ADAS-Cog11 improved by 3.3 points, reflecting an improvement of 22%, in the ANVS401-treated group.
The trial is designed to treat a combined total of 68 patients for four weeks with ANVS401.
How does ANVS401′ data stack up against other studies?
Biogen’s phase III trial which evaluated Aducanumab in patients with early Alzheimer’s disease, dubbed EMERGE, the results of which were reported in 2019, showed an improvement of 1.4-points in ADAS-Cog13 over one year.
In February 2021, Cassava reported that in a phase II study, its experimental drug Simufilam improved cognition scores by 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline over six months.
The cerebral spinal fluid and plasma samples of the 14 Parkinson’s disease and 14 Alzheimer’s disease patients who completed treatment are continuing to be analyzed to measure the reversal of the toxic cascade with additional data expected to be reported in the next two months.
The full study data, including a dose ranging analysis in 40 Parkinson’s disease, is anticipated in July or August of this year.
After completing the phase IIa trial, Annovis Bio will request a meeting with the FDA to present the results of the trial and its chronic toxicology study in animals.
If all goes well as planned, Annovis Bio expects to advance ANVS401 into late-stage studies in late 2021.
ANVS is currently trading at $36.01, up 43.68%.
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