- PYC Pharmaceuticals (PYC) lands approval from the US FDA to begin human trials of a new drug to treat the blinding eye disease Retinitis Pigmentosa (RP11)
- The genetic disease affects around one in every 100,000 people, and no other treatment options currently exist
- PYC will now seek human ethics approval for its VP-001 drug before it kicks off the first human clinical trials for an RP11 treatment
- Provided its ethics application goes smoothly, PYC expects to dose the first of 10-15 trial participants before the end of June
- PYC shares are up 2.33 per cent and trading at 8.8 cents at 12:48 pm AEDT
The US Food and Drug Administration (FDA) has cleared PYC Therapeutics (PYC) to begin human trials of an investigational new drug to treat an eye condition called Retinitis Pigmentosa (RP11).
Once underway, the trials will make PYC’s VP-001 drug the first treatment option of its kind to ever reach human clinical tests for RP11.
PYC said the genetic disease affected around one in every 100,000 people and represented an estimated addressable market of roughly $1 billion per year.
The company will now seek human ethics approval for its VP-001 drug before the dosing of the first trial participants can begin in the second quarter of 2023.
An estimated 10 to 15 patients will receive the drug to establish a safe and well-tolerated dose, which will progress into multi-dose trials next year.
PYC Therapeutics CEO Rohan Hockings said the FDA clearance was an “outstanding” achievement by the PYC team.
“The validation of PYC’s platform technology as we move ahead into human trials has implications for the company’s entire pipeline of first-in-class and potentially disease-modifying drugs,” Dr Hockings said.
“The potential for patient impact now extends well beyond RP11.”
Retinitis Pigmentosa is a blinding eye disease that begins in childhood and ultimately leads to legal blindness by middle age. It is caused by an insufficient expression of a gene known as PRPF31 in the retina.
PYC’s VP-001 product is a precision therapy that aims to restore the expression of this gene.
PYC shares were up 2.33 per cent and trading at 8.8 cents at 12:48 pm AEDT.