ASX Health Stocks: Focus on retina-disease drug study draws eyes

PYC Therapeutics has received approval for an extension study on a drug designed to combat retina disease.

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• PYC Therapeutics receives approval for an extension study

• EMV completes fabrication of its Proof of Concept device

PYC to extend retina disease study

PYC Therapeutics (ASX:PYC) has received official approval to expand its current study of an investigational drug for Retinitis Pigmentosa type 11 (RP11).

The approval has been granted in the US by the Institutional Review Board governing ongoing clinical trials in RP11.

This approval allows patients who have completed the initial Single Ascending Dose (SAD) study to participate in a new phase where they will receive multiple doses of the drug in an open-label setting.

In clinical trials, an "open-label" setting refers to a study design where both the researchers and the participants know which treatment is being administered.

This is in contrast to a "blinded" or "double-blinded" study, where either the researchers, the participants, or both are unaware of who is receiving the investigational treatment versus a placebo or standard treatment.

This extension study is crucial as it will gather additional safety and efficacy data from patients receiving repeated doses of the drug candidate.

Such data are essential for understanding how well the treatment works over time and its potential to provide sustained benefits for RP11 patients.

PYC has also submitted a protocol amendment to the US FDA to support this extension, marking a proactive step towards regulatory approval.

The company anticipates sharing comprehensive data from both the SAD and ongoing Multiple Ascending Dose (MAD) studies by the end of the year.

Retinitis Pigmentosa type 11 (RP11) is a type of genetic disorder that affect the retina, the light-sensitive tissue at the back of the eye.

RP is characterised by progressive degeneration of the retina, leading to gradual vision loss and often resulting in blindness.

EMV reveals new First Responder device

EMvision Medical Devices (ASX:EMV) has successfully completed the fabrication of its First Responder (Gen 2) Proof of Concept device.

This device marks a significant advancement in medical technology aimed at improving outcomes for stroke and traumatic brain injury patients, regardless of their location.

It brings sophisticated neurodiagnostic capabilities directly to the point of care, building upon EMVision's existing emu brain scanner technology.

The Proof of Concept device is a lighter, miniaturised version with expanded antennas to cover the entire brain in a single scan.

It will now undergo a series of studies and developments, including usability tests, reliability assessments, software enhancements, and other evaluations required for international regulatory approval.

In addition, under a deal with the Australian Stroke Alliance, supported by the Commonwealth of Australia's Medical Research Future Fund, the company has now achieved the "Ambulance Device Fabrication" milestone.

This accomplishment has triggered a non-dilutive milestone payment of $600,000 for EMV.

Originally published as ASX Health Stocks: Focus on retina-disease drug study draws eyes