• The composition of matter patent is the single most important patent for any pharmaceutical company developing a new drug

BERWYN, Pa. / Jun 27, 2023 / Business Wire / Annovis Bio, Inc. (NYSE: ANVS), a clinical stage drug platform company developing novel and transformative therapies for neurodegenerative diseases, announces the creation of a novel crystalline form of buntanetap (ANVS402), and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office.

The patent is groundbreaking because ANVS402 offers significant advantages over the previous, less structured form, including better stability, higher purity, and longer half-life, improving buntanetap’s effectiveness. ANVS402 is covered by a composition of matter claim as well as multiple claims for chronic and acute neurodegenerative diseases and for neuropsychiatric indications.

The composition of matter patent is the single most important patent for any pharmaceutical company developing a new drug. Approval of this patent will come with protection of ANVS402 and all its uses for a 20-year patent term.

“A new 20-year patent term means that we will be able to continue working on our robust pipeline, developing novel drug therapies for many of neurodegenerative diseases,” said Maria Maccecchini, Ph.D., CEO of Annovis.

The mechanism of action, favorable toxicology profile and mode of administration of Annovis’ drug, position it as a leader among the current drugs on the market and in development. While those drugs have shown little efficacy in reversing neurodegenerative diseases, only slowing progression by attempting to remove just one neurotoxic protein, buntanetap has been shown to effectively stop the synthesis of four neurotoxic proteins: Amyloid Beta, Tau, alpha Synuclein, and TDP43, the culprits behind nerve cell degeneration and death. Buntanetap early trials have shown its ability to reverse destructive effects these diseases have on thinking, memory, movement, and more.

Annovis enters an ecosystem where the only two disease-modified drugs that exist have shown well-documented, serious side effects, like amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling or bleeding. In contrast, buntanetap has been well-tolerated with low side effects (no drug-related SAEs, or serious adverse events) and each AE (adverse event) less than 2 percent in clinical trials. Buntanetap is more easily administered than its competitors’ (a single pill a day versus intravenous infusions) and, as a result, Annovis has observed rapid trial enrollment, with a low dropout rate of 6 percent, and high rates of patient compliance.

Currently, Annovis is conducting ongoing clinical trials of its lead drug candidate buntanetap: a phase III study is testing the medication in early Parkinson’s Disease, and a phase II/III study is testing the medication in moderate Alzheimer’s Disease. ANVS402 is expected to replace buntanetap in future PD and AD clinical trials after completion of a bridging study in early 2024. In addition, the phase III Parkinson’s Disease study recently received a positive safety review from the Data and Safety Monitoring Board (DSMB).

“Annovis is extremely excited about the potential of ANVS402 and its future iterations in the treatment of neurodegenerative diseases,” said Michael Hoffman, chairman of Annovis.

About Annovis Bio, Inc.

Headquartered in Berwyn, Pa., 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 information about the company’s clinical trials and patents, visit anovisbio.com, and follow the company on LinkedIn and 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.