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

Rhea-AI Summary

Annovis Bio, Inc. (NYSE: ANVS) announced the successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease. The unblinding process revealed an unexpected issue with blank plasma samples, causing a delay in the data announcement. Despite the setback, the company has resolved the issue and is preparing to report topline efficacy data in June.

Biotech Analyst

The announcement from Annovis regarding the delay in unblinding the Phase III data for buntanetap is a matter that warrants attention due to its potential implication on the efficacy and regulatory timeline of this Parkinson’s treatment. From a biotech perspective, the fact that the company recognized and addressed a discrepancy in plasma sample results speaks to their adherence to clinical and regulatory standards, which is a positive indicator. However, the delay and the reason behind it, which involves the modification of pharmacokinetic measurement methods, may introduce concerns about the rigor of the study’s execution. PK measurements are essential for understanding a drug's absorption, distribution, metabolism and excretion (ADME) and any deviation from expected results could impact the drug's perceived efficacy and safety profile. Investors should be mindful of the forthcoming efficacy data in June and consider the potential for either a positive rebound if results align with therapeutic expectations, or a downside if the efficacy outcomes are not as promising.

Pharmaceutical Development Expert

The integrity of clinical trial data, especially in Phase III, is paramount since it forms the basis for FDA review and potential market approval. Annovis’s meticulous approach to resolving the PK measurement issue ensures regulatory compliance and the validity of the trial data. The utilization of LC-MS/MS and adherence to GLP, GCP and GMP standards indicates strong commitment to quality, which is critical for advancing buntanetap through the regulatory pathway. Nonetheless, a delay in the data announcement could have a mixed impact on investor sentiment. It's essential to recognize that this delay does not necessarily connote negative findings but rather a commitment to accuracy. The true test for Annovis will be the topline results, which will determine the next stages of buntanetap’s development path.

MALVERN, Pa., May 09, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: 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.”

About Annovis Bio, Inc.

Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company’s goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and X (formerly known as Twitter).

Forward-Looking Statements

This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Investor Contact:

Maria Maccecchini, Ph.D.

maccecchini@annovisbio.com

FAQ

What did Annovis announce regarding the Phase III data in Parkinson’s Disease?

Annovis announced the successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease.

When can the topline efficacy data be expected?

Topline efficacy data is expected to be announced in June.

What caused the delay in the data announcement?

The delay was caused by an unexpected issue with blank plasma samples during the unblinding process.

Who is the Founder, President, and CEO of Annovis?

Maria Maccecchini, Ph.D. is the Founder, President, and CEO of Annovis.

What was the reason behind the delay in the data announcement according to Maria Maccecchini?

The delay was due to a modification in the method of pharmacokinetic measurements, affecting the accuracy of the results.