PYC Therapeutics is a clinical-stage biotechnology company creating a new generation of RNA therapies to change the lives of patients with genetic diseases. The Company utilises its proprietary drug delivery platform to enhance the potency of precision medicines within the rapidly growing and commercially proven RNA therapeutic class. PYC's drug development programs target monogenic diseases - the indications with the highest likelihood of success in clinical development.

The US Food and Drug Administration (FDA) has cleared PYC's Investigational New Drug (IND) application for its investigational drug candidate (known as VP-001 3) directed towards the treatment of Retinitis Pigmentosa type 11 (RP11). This milestone represents the first potential treatment option to enter human trials for this disease. PYC has now applied for human ethics approval before commencing to enrol patients in the clinical trial and anticipates dosing the first RP11 patient with VP-001 in 2Q23.

Human studies will commence with a single ascending dose protocol treating an estimated 10 to 15 RP11 patients with the objective of establishing a safe and well-tolerated dose to progress into multi-dose trials next year. RP11 is a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age. The disease affects ~1 in every 100,000 people and is caused by insufficient expression of the PRPF31 gene in the retina.

There are currently no treatment options available for patients with RP11 nor are there any in clinical development. VP-001 is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina. VP-001 utilises PYC's proprietary drug delivery technology to overcome the major challenge for RNA drugs by ensuring that sufficient drug reaches its target inside the cells affected by RP11.

PYC has advanced the first drug candidate for the treatment of a blinding eye disease called Retinitis Pigmentosa type 11 (RP11) into human trials The progress comes with the US Food and Drug Administration (FDA) clearing PYC's Investigational New Drug (IND) application for its RP11 drug candidate PYC plans to begin dosing RP11 patients with this drug candidate in second quarter 2023 There are no treatment options currently available for patients with RP11 which represents an estimated >$1 billion p.a. addressable market.