Clinical-stage neurodegenerative disease-focused platform company Annovis Bio Inc. (ANVS:NYSE American), which is engaged in developing medicines to treat Alzheimer's disease (AD) and Parkinson's disease (PD), announced that "it is pleased by the positive interim results released on July 28 from Phase 2 clinical trials of its lead compound, ANVS401 (Posiphen)."
Annovis advised that patients taking part in the initial cohorts in the studies demonstrated statistically significant positive results in both their cognitive and motor skills during the first 25 days after taking ANVS401. Specifically, the company noted that ANVS401 was shown to demonstrate significant measured improvements in cognitive function in AD patients and increases in motor function in PD patients.
The firm added that it was also able to successfully corroborate the efficacy of ANVS401 based upon observed and analyzed patient biomarker data that showed reductions in neurotoxic proteins, improvement in axonal health and reduced levels of inflammation. The company indicated that it expects to receive the next clinical data readout in Q3/21 and in the coming months plans to release the outcome of its review of all biomarkers of the toxic cascade.
The company's founder, CEO and President Maria L. Maccecchini, Ph.D., commented, "We were pleased to see improvements in cognition and motor skills in only 25 days and are hopeful we will see cumulative and long-lasting positive outcomes from the use of ANVS401 through the remainder of the trials."
The firm indicated that in the ongoing Phase 2 ADAS-Cog study, AD-afflicted patients in the treatment group performed better and showed improvement in all four of the ADAS-Cog tests compared to the control group. The company highlighted that the patients who were given ANVS401 demonstrated a 30% improvement in ADAS-Cog11 and also performed much better in the WAIS coding, a test designed to measure speed in movement and thinking. Annovis reported that there were also some positive, though not statistically significant trends observed in MMSE and total CDR scores.
The company indicated that in the MDS-UPDRS test, PD patients who were administered ANVS401 showed a cumulative 14% increase to 6.2 points in all four parts of UPDRS test, versus the placebo group, which showed a decline of 4.2 points. Like the AD patients, PD patients who took ANVS401 showed a 6.1-point improvement in the WAIS coding test measuring speed in movement and thinking.
Annovis Bio is a clinical-stage, drug platform company based in Berwyn, Pa., focused on addressing acute and chronic neurodegenerative diseases including AD, PD and Alzheimer's in Down Syndrome (AD-DS). The firm concluded that nerve cells get sick and die when information flow is impaired. Annovis stated that "it believes that it is 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." The company indicated that at present it is conducting an ongoing Phase 2 trial in AD patients along with a second separate Phase 2 study in both AD and PD patients. The firm asserted that "in the AD/PD study its drug improves memory loss and dementia associated with AD, as well as body and brain function in PD."
Annovis Bio started the day with a market cap of around $278.9 million with approximately 8.1 million shares outstanding and a short interest of about 5.7%. ANVS shares opened more than 5% higher today at $36.28 (+$1.85, +5.37%) over Friday's $34.43 close. The stock has traded today between $35.15 to $143.1999 per share and closed at $41.20 (+$6.77, +19.66%).
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