Annovis blames ‘data cleaning’ efforts for delaying phase 3 Parkinson’s readout

The winding journey of Annovis Bio’s potential Parkinson’s disease therapy through the clinic isn’t over quite yet, with the biotech revealing today that much-anticipated phase 3 data won’t be published this month as planned.

Data from the late-stage study of buntanetap had been due to read out at the end of January. But Annovis said this morning that the timeline has been delayed due to “ongoing data cleaning efforts to ensure the accuracy and reliability of the study results.”

In the Jan. 24 release, the company didn’t offer an estimated date of when we are likely to see the data.

It was enough to spook some investors, who sent the Pennsylvania-based biotech’s stock down 10% to $10.40 in pre-market trading Wednesday.

“We acknowledge the ongoing anticipation for the phase 3 data announcement initially set for the end of January 2024,” CEO Maria Maccecchini, Ph.D., said in the release. “However, the delivery of the cleaned data is now delayed as we work to provide the most accurate results by ensuring the process is conducted diligently and thoroughly."

“During this period, the company remains blinded to the data, and the statistical analysis is yet to be performed,” Maccecchini continued. “We understand your potential frustration with the required extension, and we want to stress that our focus is on delivering results that are trustworthy. We are working hard to provide them to you very soon.”

The study launched in the U.S. and Europe in August 2022 and saw the last patient visit on Dec. 5, 2023. A total of 616 patients were screened, with 471 completing the trial, which involved receiving either 10 mg or 20 mg of buntanetap or placebo for six months.

Buntanetap is a once-daily pill designed to inhibit a variety of neurotoxic proteins. Annovis had previously touted the drug as potentially being a more effective treatment for Alzheimer’s than Biogen’s Aduhelm. However, disappointing phase 2 data back in 2021 put that claim in doubt.

A fresh phase 2/3 study of the drug in Alzheimer’s is ongoing. In November, Maccecchini said that the company still sees buntanetap as a worthy competitor to the two FDA-approved Alzheimer’s drugs—Aduhelm and Eisai and Biogen’s Leqembi—both of which require IV infusions.

Annovis ended September with cash and equivalents of $6.4 million, having spent $13.8 million in R&D costs over the third quarter, mostly on its late-stage buntanetap trials for Parkinson’s and Alzheimer’s.