Annovis Bio Provides Third Quarter 2020 and Year-to-Date Business Highlights

Rhea-AI Summary

On October 15, 2020, Annovis Bio Inc. (ANVS) reported significant advancements in its business operations for Q3 2020. The company announced the initiation of a Phase 2a clinical study for its lead compound, ANVS401, targeting Alzheimer’s and Parkinson’s diseases, with preliminary data expected in early 2021. Annovis Bio also restarted a previously halted Alzheimer's study, completed a chronic toxicology study with favorable safety results, and published three scientific papers corroborating its findings. Additionally, the company secured two patents and filed five more related to treatments for neurodegenerative diseases.

Positive

• Initiated Phase 2a study for ANVS401 in AD and PD, with initial data due early 2021.
• Restarted an AD study previously on hold, with data expected in 2021.
• Completed a chronic toxicology study showing no significant negative side effects.
• Published three scientific papers validating the efficacy of ANVS401.
• Secured two new patents and filed five additional ones.

Negative

• None.

BERWYN, Pa., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Annovis Bio Inc. (NYSE American: ANVS), a clinical-stage drug platform company addressing Alzheimer’s disease (AD), Parkinson’s disease (PD) and other neurodegenerative diseases, today announced its business highlights for the third quarter ended September 30, 2020.

“We are thrilled with the strong progress we have made since our IPO in January of this year and the continued productivity despite the COVID-19 pandemic,” said Maria Maccecchini, Ph.D., Founder and Chief Executive Officer. “A major milestone in the third quarter was the start of our new phase 2a study in Alzheimer’s and Parkinson’s patients, which we expect to report preliminary data from in the first quarter of 2021. Based on what we know today, we believe that our breakthrough platform technology could result in medicines that can change the world.”

There has been a string of clinical trial failures for drugs based on the belief that sticky brain plaques cause AD. With 500 failed drugs based on that hypothesis, Annovis Bio has developed a new approach to treat AD as well as PD by attacking multiple neurotoxic proteins simultaneously. In six animal models, ANVS401 reduced neurotoxic proteins, improved axonal transport, lowered inflammation, and restored healthy nerve cells in both AD and PD. Based on publicly available data, no other drug has been shown in animal studies to impede the whole toxic cascade and show preclinical efficacy in both AD and PD. 

Third Quarter and Year-to-Date 2020 Business Highlights

• Started a Phase 2a clinical study in patients with mild to moderate AD and PD. This Phase 2a trial is a one-month study that will treat 14 AD and 14 PD patients at up to 15 sites across the US. The study is measuring all the steps in the toxic cascade leading to nerve cell death and how ANVS401 might reverse the toxic cascade and recover normal brain function. 12 markers will be measured in spinal fluid as well as in plasma. Initial data from this trial is expected in early 2021. This study will be followed by a dose response study in 40 PD patients, and the Company expects the final readout by late summer 2021.
  
  
• Restarted the AD study that was put on hold due to Covid-19. This Phase 2a trial of the Company’s lead compound, ANVS401, is a one-month study in 24 AD patients conducted in collaboration with the Alzheimer Disease Cooperative Study at six sites in the US. Prior to suspension of enrollment, 14 patients had been enrolled and treated in this trial. Data from this trial is expected in 2021.
  
  
• Completed treatment of animals in the Company’s chronic toxicology study funded by the NIH. The Company reported that rats treated with ANVS401 for six months showed no significant negative side effects. The study has completed the treatment of dogs for nine months and the Company is awaiting the analysis of the results. Successful completion of the chronic toxicology study will enable the Company to conduct long-term studies of ANVS401 in humans.
  
  
• Completed work on the mechanism of action for ANVS401 using proteomics, microscale thermophoresis and bio-layer interferometry. As anticipated, research showed that the mechanism of action for ANVS401 is specific for neurotoxic aggregating proteins.
  
  
• Started collaboration to further elucidate the mechanism of action for ANVS401 by binding, crystallography, and cryo-electron microscopy. This work shows the actual interactions and complex formations between iron regulatory protein 1 and the atypical iron response element of neurotoxic aggregating protein mRNAs by different visualization methodologies.
  
  
• Published three scientific papers related to ANVS401. In September, the Company announced the publication of a manuscript in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, “Targeting increased levels of APP in Down syndrome: Posiphen-mediated reductions in APP and its products reverse endosomal phenotypes in the Ts65Dn mouse model,” which demonstrated improved axonal transport in nerve cells and brain of down syndrome mice, an animal model of AD. In April, the Company announced the publication of data in two double-blind, placebo-controlled animal studies – one in AD mice and one in PD mice -demonstrating preclinical efficacy of ANVS401 in both diseases. The AD study was published in Alzheimer’s & Dementia: Translational Research & Clinical Interventions and the PD study was published in the American Journal of Neurodegenerative Disease.
  
  
• Granted two patents and filed five additional patents. In March, the European Patent Office granted the Company’s patent (EP 2683242) for a method of treating Alzheimer’s disease in humans by administering ANVS401. Previously, the Company announced it was issued a patent (US 10,383,851) for a method of treating Parkinson’s disease, Lewy body dementia and other Lewy body diseases in humans by administering ANVS401. Four divisional patents were also filed related to tauopathies (frontotemporal dementia, chronic traumatic encephalopathy), amyotrophic lateral sclerosis, Huntington’s disease, and prion diseases. Finally, a provisional patent application concerning a method of inhibiting, preventing, or treating neurological injuries due to viral, bacterial, fungal, protozoan, or parasitic infections in humans and in animals via administration of ANVS401 or related compounds was filed with the U.S. Patent & Trademark Office.
  
  

About Annovis Bio
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (AD-DS). We believe that we are the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We expect our treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. We have an ongoing Phase 2a study in AD patients and have commenced a second Phase 2a study in AD and PD patients. For more information on Annovis, please visit the company’s website: www.annovisbio.com.

Forward-Looking Statements
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “expect,” “believe,” “will,” “may,” “should,” “estimate,” “project,” “outlook,” “forecast” or other similar words, and include, without limitation, statements regarding the timing, effectiveness and anticipated results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including that clinical trials may be delayed. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2019 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio, Inc. undertakes no duty to update such information except as required under applicable law.

Investor Relations:
Dave Gentry, CEO
RedChip Companies Inc.
407-491-4498
Dave@redchip.com

SOURCE: Annovis Bio, Inc.

 

FAQ

What is Annovis Bio's recent clinical trial update for ANVS401?

Annovis Bio announced that it has started a Phase 2a clinical study for ANVS401 in patients with Alzheimer's and Parkinson's diseases, with preliminary data expected in early 2021.

When can we expect data from the Phase 2a clinical study of ANVS401?

Initial data from the Phase 2a clinical study of ANVS401 is expected to be reported in the first quarter of 2021.

What are the main highlights from Annovis Bio's Q3 2020 report?

Key highlights include the initiation of a Phase 2a study for ANVS401, the restart of a halted AD study, successful completion of a chronic toxicology study, and the publication of three scientific papers.

How many patents has Annovis Bio secured recently?

Annovis Bio has secured two new patents and filed five additional patents related to neurodegenerative diseases.