- Cynata Therapeutics’ (ASX:CYP) announces the enrolment and treatment of the first participant (CYP-001) in its Phase 2 clinical trial for high-risk acute graft versus host disease (aGvHD)
- US FDA has granted clearance for an Investigational New Drug (IND) application for CYP-001
- The ongoing trial is investigating CYP-001 as a potential immune-modulating treatment for aGvHD
- Approval granted to initiate the trial in Australia, US, Turkey
- CYP last traded at 20c, at 12:45pm AEDT
The market has responded favourably to Cynata Therapeutics’ (ASX:CYP) announcement regarding the enrolment and treatment of the first participant (CYP-001) in its Phase 2 clinical trial.
The biotechnology company, specialising in cell therapeutics, is conducting the trial for the study of high-risk acute graft versus host disease (aGvHD).
“The treatment of the first patient in this Phase 2 trial marks a milestone moment in the clinical development journey of CYP-001 for aGVHD,” Cynata’s CEO Dr Kilian Kelly said.
“We are continuing to open additional clinical centres, and we anticipate completion of enrolment by the end of this calendar year, with primary results available in the second half of 2025.”
The US FDA has granted clearance for an Investigational New Drug (IND) application for CYP-001, designating it as an Orphan Drug for the treatment of aGvHD.
aGvHD poses a severe risk to individuals undergoing bone marrow transplants or similar procedures, as it involves immune cells in the transplant attacking the recipient’s tissues as foreign.
The ongoing trial is investigating CYP-001 as a potential immune-modulating treatment for aGvHD.
This global Phase 2 trial aims to enrol 60 high-risk aGvHD patients, who will be randomised to receive either steroids plus CYP-001 or steroids plus a placebo.
Approval has been granted to initiate the trial in Australia, US and Turkey, with multiple clinical centres in these regions actively recruiting participants.
CYP last traded at 20c, at 12:45pm AEDT.