- PYC Therapeutics (PYC) completes single-dose toxicology of its investigational Retinitis Pigmentosa type 11 (RP11) treatment drug candidate
- According to PYC, the studies proved the drug was safe and well-tolerated at all dose levels assessed, paving the way for first in-human studies of the treatment
- The company says it will now submit an Investigational New Drug application for its product to initiate a combined clinical trial in the first quarter of 2023
- Shares in PYC are up 2.86 per cent to 7.2 cents at 3:45 pm AEDT
PYC Therapeutics (PYC) has successfully completed single-dose toxicology of its investigational Retinitis Pigmentosa type 11 (RP11) treatment drug candidate, VP-001.
The company said the studies proved the drug was safe and well-tolerated at all dose levels assessed, paving the way for first in-human studies of the treatment
PYC combined two complementary platform technologies, RNA drug design capabilities and a proprietary drug delivery technology, to create a new generation of RNA therapeutics to treat patients with genetic diseases.
As part of the RP11 tests, two single-dose good laboratory practice (GLP) toxicology studies were conducted — one in rabbits and the other in non-human primates.
All dosing was bilateral, and the drug was administered via injection into the vitreous of the eye, which is the same route of administration anticipated to be used in planned human clinical trials.
Progression of VP-001 into a combined phase one/two clinical study will represent the first potentially disease-modifying therapy for RP11 to progress into clinical development.
The company anticipates filing an investigational new drug application in support of VP-001 before the end of this year.
If successful, PYC then plans to progress to human clinical trials in the first quarter of 2023.
Shares in PYC were up 2.86 per cent to 7.2 cents at 3:45 pm AEDT.