The results of the single-dose GLP toxicology studies showed no observed adverse effects at any of the assessed doses. The competitive advantages of PYC’s proprietary RNA therapeutics platform for the treatment of retinal disease are now apparent across both efficacy (see ASX announcement of 3 October 2022) and safety/tolerability dimensions.
These toxicology studies were completed under GLP conditions, a standard required for submissions to regulatory bodies including the United States (US) Food and Drug Administration (FDA).
PYC anticipates filing an Investigational New Drug (IND) application in support of VP-001in Q4 2022 and, if successful, progressing to human clinical trials in 1Q 2023.
Ann: Successful Toxicology Studies Pave Way for Human Trials, page-3
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