Annovis Bio Announces First Patient Dosed in Phase 3 Trial in Patients with Early Parkinson’s Disease

[PDWarrior1900]

Annovis Bio Announces First Patient Dosed in Phase 3 Trial in Patients with Early Parkinson’s Disease

BERWYN, Pa., August 24, 2022 -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the first patient in the Phase 3 clinical trial evaluating buntanetap in early Parkinson’s Disease (PD) has been dosed.

The Phase 3 trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap. The trial will enroll a total of 450 early PD patients to be treated with 10mg buntanetap, 20mg buntanetap or a placebo, on top of their standard of care for six months.

Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III will be used as primary endpoints, while total MDS-UPDRS and Participant Global Impression of Change will be secondary endpoints. In addition, Wechsler Adult Intelligence Scale, plasma biomarkers and Mini-Mental State Examination will be evaluated as exploratory endpoints.

The Company previously reported results from its Phase 2a study of buntanetap in PD patients, which were treated with 5mg, 10mg, 20mg, 40mg or 80mg daily with no clinically significant adverse events. Additionally, treatment with buntanetap resulted in statistically significant improvement in motor function and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting both the primary and secondary endpoints.

Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis Bio said: “Buntanetap has shown promising preliminary safety data in all clinical work to date. Just as encouraging is the significant improvement in speed of movement, motor function and cognitive function observed in early to moderate PD patients treated with buntanetap in the Phase 2a trial. Now, as we officially advance buntanetap into a Phase 3 trial, with a longer treatment duration and a dose range shown to be efficacious in early studies, we are one step closer to delivering a solution that can transform the lives of patients with Parkinson’s Disease.”

About Buntanetap

Buntanetap (previously known as ANVS401 or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to lower levels of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 2a clinical trial in AD and PD patients, treatment with buntanetap resulted in statistically significant improvement in motor function in PD patients and cognition in AD patients. Additionally, buntanetap was shown to reduce biomarkers associated with AD or PD, it was well-tolerated and safe, and its pharmacokinetics were found to be in line with levels measured earlier in humans, meeting primary, secondary and exploratory endpoints.

About Annovis Bio, Inc.

Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. is a late-stage clinical drug platform company developing transformative therapies that treat neurodegenerative disorders such as Alzheimer's disease (AD), Parkinson's disease (PD) and other chronic and acute neurodegenerative diseases. The Company believes that it is the only company developing a drug that inhibits more than one neurotoxic protein, improves the information highway of the nerve cell, known as axonal transport, reduces inflammation and protects nerve cells from dying in chronic and acute neurodegeneration. Annovis conducted two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/PD study, buntanetap showed improvements in cognition and memory in AD as well as body and brain function in PD patients.

For more information on Annovis Bio, please visit the Company's website annovisbio.com and follow us on LinkedIn and Twitter.

[Smittybear7]

Thanks for sharing. Is there any study done with older people with Parkinson's? Is this drug something that will help older people?

[PDWarrior1900 in reply to Smittybear7]

I have no other info, but I hope it does... I'm 70 years old... I have my first neuro appointment next month (to confirm something I've known for more than a year)

[Smittybear7 in reply to PDWarrior1900]

Good luck to you! Thanks for providing so much good information.

[rancsikanna in reply to PDWarrior1900]

Hi! May I ask you whether you participate in buntanetap trial?

[PDWarrior1900 in reply to rancsikanna]

i don't qualify -- I'm not "officially" diagnosed with PD (according to my very VERY stupid neuro/MDS from Cedars-Sinai Hospital) --- but I know that at least one of our members here is participating now ... sorry, I can't remember his name

[Hilo64 in reply to PDWarrior1900]

I recently finished participating in a clinical trial and my neurologist is recommending i enroll in the buntanetap trial.

[PDWarrior1900 in reply to Hilo64]

good luck! we are all praying for your success!

[jeffreyn]

There are now 6 locations mentioned in the updated trial record (August 24, 2022):

- two in DeLand, Florida (recruiting);

- one in Miami, Florida (not yet recruiting);

- one in Pembroke Pines, Florida (not yet recruiting);

- one in Memphis, Tennessee (not yet recruiting);

- one in Spokane, Washington (recruiting).

clinicaltrials.gov/ct2/show...

[PDWarrior1900 in reply to jeffreyn]

the president/CEO of the company has been exchanging emails with me... she said that she would soon have a revised list and email me a PDF... then I'll post it here

[PDWarrior1900 in reply to jeffreyn]

hi jeffreyn -- there are now over '40' USA clinical trial phase 3 sites that you can volunteer to join

download the list and contact info here:

docs.google.com/spreadsheet...

[Boscoejean]

Inclusion Criteria:

Diagnosis of idiopathic Parkinson Disease according to MDS Clinical Diagnostic Criteria for Parkinson's Disease.

H&Y score =1, 2 or 3 during ON-state & OFF-state <2hrs per day.

Male or female aged 40 - 85 years.

[Farooqji]

Is there anyone on this forum who has participated in phase 2a trial

[PDWarrior1900]

here's a link to the 40+ USA clinical trial sites that you can volunteer to join

docs.google.com/spreadsheet...