Annovis Bio (NYSE: ANVS), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, has announced successful completion of data cleaning for its Phase III study of buntanetap in patients with early Parkinson’s disease (“PD”). According to the announcement, topline efficacy data is expected in June. “When we reached the point of unblinding the data for the PD Phase III study, we discovered an unexpected issue: too many plasma samples showed no presence of buntanetap. We were expecting 33% blank samples from the placebo group, but we saw over 50% blank samples. We were afraid that we had mixed up bottles and that patients weren’t given what they were supposed to. If that had happened, the study would have been worthless. We promptly started searching for a possible explanation at every step of the way… We were left with the pharmacokinetic (‘PK’) measurements. PK is measured by LC-MS/MS with a very expensive set of equipment under GLP, GCP, GMP, and is regulated by very strict FDA rules. It turns out that the group, which was evaluating the PK, modified the method, unfortunately affecting the measurements. We repeated the PK of the same samples and obtained an expected 33% of blank samples accounting for placebo,” said Annovis Founder, President and CEO Maria Maccecchini, Ph.D. “The whole process took us two months, which caused the delay in data announcement. However, due to our effort and immediate actions, we are now confident and ready to evaluate the data for the public and the FDA and report topline results in June. Thank you very much for your understanding and patience.”
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About Annovis Bio Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio 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 more information on Annovis Bio, visit the company’s website at www.AnnovisBio.com.
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