Annovis Bio claims wins in Alzheimer's and Parkinson's, shares skyrocket; FDA delays decision for Omeros' narsoplimab
A Berwyn, PA-based biotech is claiming a huge win in both Alzheimer’s and Parkinson’s diseases, and it’s sending their shares skyrocketing.
Annovis Bio reported results from a small cohort of a Phase II study, containing 14 Alzheimer’s patients and 14 Parkinson’s patients in a trial for a program called ANVS401. Measuring cognitive improvement with an assessment scale known as ADAS-Cog11, Annovis said patients’ scores improved by about 30% over their baselines after 25 days.
That amounted to a p-value of p=0.04, with an average numerical gain of 4.4 points. The biotech also compared the 4.4 gain to patients in the placebo group of the cohort, noting the treatment arm saw a 22% improvement (3.3 average gain) versus the control. Annovis’ p-value here was p=0.13.
Separately, Annovis reported Thursday afternoon that the Parkinson’s patients saw significant reductions across several inflammatory markers related to that disease. The data built upon results Annovis released in March, which the company said showed positive efficacy in “speed of execution.”
Annovis says it’s the first double-blinded, placebo-controlled data showing improvement in the Alzheimer’s scale as well as functional improvement in Parkinson’s. News of the results sent Annovis shares $ANVS soaring nearly 140% in early Friday trading.
“While we do not know how ANVS401 will affect cognition after more than one month of treatment, the present results show promise that the drug may improve or stop the course of AD,” the company said in a release.
FDA delays decision for Omeros’ narsoplimab
Omeros will have to wait a little longer for a potential approval regarding its narsoplimab program.
The Seattle biotech had sought an OK hematopoietic stem cell transplant-associated thrombotic microangiopathy, but the FDA said it needs more time to review its BLA package. The review has been classified as a “major amendment,” resulting in a new PDUFA date of Oct. 17, Omeros said.
“Omeros views the information provided in response to FDA’s information request as further supporting the application, and we look forward to making narsoplimab available to HSCT-TMA patients and their physicians as soon as possible,” CEO Gregory Demopulos said in a statement.
Omeros had previously won a priority review for the candidate, with the FDA accepting its BLA pitch back in January.