Cynata Therapeutics receives approval to launch phase two trial of CYP-001 in Turkey

• Cynata Therapeutics (ASX:CYP) secures regulatory and ethics approval to commence its phase two clinical trial of its novel drug candidate, CYP-001
• The trial is for patients with high-risk acute graft versus host diseases (HR-aGvHD) and will take place at clinical centres in Turkey
• The global trial is enrolling 60 patients with HR-aGvHD to offer randomised treatments of steroids plus CYP-001, or steroids plus a placebo
• The first site visit is geared to occur in the next 1-2 months, and the trial has already opened for recruitment in Australia and the USA
• Shares last traded at 11.5 cents

Cynata Therapeutics (ASX:CYP) has secured regulatory and ethics approval to commence its phase two clinical trial of its novel drug candidate, CYP-001.

The trial focuses on patients suffering from high-risk acute graft-versus-host diseases (HR-aGvHD) and will be conducted at clinical centres across Turkey.

This international trial aims to enrol approximately 60 HR-aGvHD patients, who will be randomly assigned to receive either steroids combined with CYP-001 or steroids combined with a placebo. Notably, CYP-001 is also known as Cymerus.

The drug, derived from anti-inflammatory mesenchymal stem cells (MSC2), will be administered via intravenous infusion, a method previously demonstrated to exhibit encouraging safety and efficacy results in Cynata’s phase one clinical trial.

“We are delighted to receive approval to commence this trial in Turkey, which is a country that we expect will make a substantial contribution to this trial,” CYP CEO Dr Kilian Kelly said.

“Start-up activities for this trial continue to progress well, and we remain focused on our goals of completing patient recruitment by the end of 2024, with primary results expected in the second half of 2025.”

Cynata plans to open multiple clinical centres in Turkey, with the first site visit anticipated within the next 1-2 months. The company has already opened the trial for recruitment in Australia and the USA.

CYP shares last traded at 11.5 cents.