Annovis Bio Provides Corporate Updates and Announces First Quarter 2024 Financial Results

MALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, provided updates from across the organization and announced first quarter financial results.

Clinical Updates

AD Phase II/III Study

• On April 29, Annovis announced statistically significant Phase II/III data in patients with early Alzheimer’s disease (AD).
  • Significantly higher rate of improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD;
  • Improvement in cognition measured by ADAS-Cog 11 at three months was 3.3 points as compared to 0.3 for placebo, consistent with previous Phase II AD/PD and Discovery studies;
  • Plasma Tau protein levels were reduced, consistent with previous Phase II biomarker data.

• Based on the findings of this short study, Annovis plans to conduct a pivotal 18-month disease-modifying Phase III trial in biomarker-positive early AD patients.
  

PD Phase III Study

• On January 24, Annovis refined the timeline for Parkinson’s disease (PD) Phase III data announcement, originally set for the end of January, due to necessary cleaning efforts required to deliver reliable and accurate results.

• On May 9, Annovis announced unblinding of the Phase III data and intends to release topline results in June of 2024.

• The Phase III trial was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients, on top of their existing standard of care. Patients were treated with 10 mg, 20 mg, or placebo for 6 months. Out of 616 patients screened, 523 were randomized and 471 completed the study across 67 sites (43 in the United States and 24 in the European Union).
  

Patents

• Annovis announced on January 30, 2024 the filing of a patent application covering the use of buntanetap and its analogues for the treatment of neuropsychiatric indications.

• This patent follows the U.S. Provisional Application No. 63/440,890, which was filed on January 24, 2023.

• This patent application addresses mental illnesses such as autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, anxiety and schizophrenia, which have been shown to share similar pathological abnormalities with certain neurodegenerative diseases, including disruptions in synthesis of neurotoxic proteins, impairment of axonal transport, inflammation, and nerve cell death.