- PYC Therapeutics (PYC) is set to progress to the first in-human trials for its program addressing blinding eye diseases
- The company is developing its co-lead drug candidate known as VP-001 and has obtained data for safe and well-tolerated doses of the drug
- PYC says the results are a major step towards initial in-human clinical studies as it aims to develop the first potential therapy for patients with Retinitis Pigmentosa type 11
- The results also validate the company’s drug delivery system providing support for its pipeline and future ocular programs
- Shares have been trading 3.3 per cent higher at 15.5 cents
PYC Therapeutics (PYC) is set to progress to the first in-human trials for its program addressing blinding eye diseases.
The company is developing its co-lead drug candidate, known as VP-001, to address the underlying cause of Retinitis Pigmentosa type 11.
This condition causes cells in the retina to degenerate slowly and progressively, resulting in degrees of blindness.
PYC is combining two platform technologies including RNA drug design capabilities and a proprietary drug delivery technology to create a new generation of RNA therapeutics to target the underlying cause of the disease.
If the therapy is successful, it will be the first of its kind.
At the end of October the company announced that its drug delivery system had shown the ability to reach the target cells in the deepest layers of the retina.
Now, it has obtained data that demonstrates safe and well-tolerated doses of VP-001 from a study in monkeys.
PYC’s Chief Development Officer Dr Glenn Noronha said the results from the studies continue the systematic evaluation of the platform with work now being carried out to guide the dosing interval for the first human studies.
“Drug development requires that data are built from a foundation, layer by layer, and each step in this process provides information toward the potential for bringing therapies to patients,” Dr Noronha said.
“This is one such important step toward first in human clinical evaluation.”
Good Laboratory Practice toxicity studies are scheduled to begin in quarter one of 2022 and will assess safety and tolerability of VP-001 following both single and repeat dosing.
These studies are said to be critical for the company’s IND filing with the US FDA to enable initiation of first in human trials in the RP11 program later in the year.
Additionally, the results validate the company’s drug delivery technology and subsequently supports development of its five therapies for blinding eye diseases and future ocular programs.
PYC said it is in the process of expanding its pipeline of ocular therapeutics beyond orphan disease programs to much larger patient populations affected by more common forms of blinding eye disease.
Shares were trading 3.3 per cent higher at 15.5 cents at 11:25am AEDT.