Annovis Announces Unblinding of the Buntanetap Phase III Data in Parkinson’s Disease

[Canddy]

This press release came out yesterday May 9, 2024. It explains why the data analysis for the Parkinson's Disease study has been delayed. Even if the results are positive, I believe the FDA may require another large Phase III study before evaluating buntanetap for approval (just my opinion having worked in clinical research many years).

Annovis Announces Unblinding of the Buntanetap Phase III Data in Parkinson’s Disease

GLOBENEWSWIRE

7:30 AM ET 05/09/2024

MALVERN, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, today announced successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease (PD). Topline efficacy data is expected in June.

The Phase III study was completed in 4Q 2023 with an original plan for data announcement in 1Q 2024, however the Company faced a delay in the process of data cleaning beyond the original prognosis. Maria Maccecchini, Ph.D., Founder, President, and CEO of Annovis, explains in detail the reason behind this delay:

"When we reached the point of unblinding the data for the PD Phase III study, we discovered an unexpected issue: too many plasma samples showed no presence of buntanetap. We were expecting 33% blank samples from the placebo group, but we saw over 50% blank samples. We were afraid that we had mixed up bottles and that patients weren’t given what they were supposed to. If that had happened, the study would have been worthless. We promptly started searching for a possible explanation at every step of the way. We checked the content of the bottles – correct. We checked the distribution of the bottles – correct. We checked the labeling of the plasma samples – correct. We checked the distribution of the plasma samples – correct. So, we were left with the pharmacokinetic (PK) measurements. PK is measured by LC-MS/MS with a very expensive set of equipment under GLP, GCP, GMP, and is regulated by very strict FDA rules. It turns out that the group, which was evaluating the PK, modified the method, unfortunately affecting the measurements. We repeated the PK of the same samples and obtained an expected 33% of blank samples accounting for placebo.

The whole process took us 2 months, which caused the delay in data announcement. However, due to our effort and immediate actions, we are now confident and ready to evaluate the data for the public and the FDA and report topline results in June.

Thank you very much for your understanding and patience.”

[jeffreyn]

"Even if the results are positive, I believe the FDA may require another large Phase III study before evaluating buntanetap for approval"

Interesting, and quite a contrast to something the CEO said, in reference to the Alzheimer's Phase II/III trial results, in her 6 May letter to stockholders.

"We believe that the FDA will accept buntanetap for symptomatic relief [of AD] and will allow us to continue with the next pivotal Phase III study for disease-modification."

irpages2.eqs.com/websites/a...

[ChucklesUSA in reply to jeffreyn]

The requirements for approval of a Symptom Modifying Therapy is less than that for a Disease Modifying Therapy. Harder to show the disease has been stopped or slowed than the patient feels better.

Acceptance for review by the FDA is not approval, but Annovis’ statement indicates they believe they will advance buntanetap as a Symptom Modifying Therapy in AD.

[LynnP1974]

With all the decades of so called “research” on Parkinson’s it’s infuriating that we’re still stuck in the “you need a pill” phase of sticking a bandaid on the illness. My husband was diagnosed last year at age 52. We’re treating it like it’s a metabolic disorder. Trying to figure out the cause, even though we know that we may never find out. We’re seeing a functional medicine dr and testing him for mold, heavy metal toxicity and gut health/leaky gut. So far the metals and gut tests came back really good, but was told that he needs more healthy gut bacteria. He’s had gut issues his entire life that started as a young baby. Diet is so important and it’s so easily overlooked. Doing experiments on my husband, he does so much better with a very low carb diet. Stress I’m noticing makes things 1,000 times worse ( he was always a person who could handle stress pretty well). All the chemicals in our foods and pesticides… wheat, grains, soy, corn and seed oils should be avoided at all costs. I’m determined to help slow down this condition. Also upping the fatty red meat is important. Don’t follow the US government food suggestions, it’s all a lie. Sorry for the rant. I’m frustrated with our entire medical systems. It’s all about money, not about health.

🙏🙏