Highlights

• Cynata has completed a strategic review of its clinical development portfolio.
• The review focused on ongoing and planned clinical development programs.
• The company intends to achieve recruitment targets in the new financial year.

Clinical-stage biotechnology company Cynata Therapeutics Limited (ASX:CYP) has reported the completion of a strategic review of its clinical development portfolio, led by Dr Kilian Kelly, the recently appointed Managing Director and CEO.

The review included a comprehensive assessment of ongoing and planned clinical development programs with inputs from clinical centres, contract research organisations and existing strategic partners. The objective is the completion and timely progression of Cymerus^TM mesenchymal stem cell (MSC) clinical trial programs.

Cynata has also shared updates about the Phase 2 clinical trial of CYP-001 in patients with HR-aGvHD (High-Risk acute Graft versus Host Disease), Phase 3 SCUIpTOR trial of CYP-004 in patients with osteoarthritis, Phase 1 clinical trial of CYP-006TK in patients with diabetic foot ulcer and the proposed Phase 1 clinical trial of CYP-001 in patients who have experienced renal transplantation.

Here’s the summary of expected dates across the trial programs. 

Planned phase 2 clinical trial in Graft versus Host Disease

Currently, the company is engaged in finalising trial startup activities, comprising gaining ethics and regulatory approvals for the Phase 2 HR-aGvHD clinical trial. The company expects that the US and Australian centres will be opened for recruitment this quarter. CYP is eyeing approvals to begin trials in multiple European countries.  

Phase 3 SCUlpTOR trial in osteoarthritis

Significant progress has been reported concerning the Phase 3 osteoarthritis trial planned by the company in collaboration with the University of Sydney. This year, the enrolment rate surged substantially and around 300 patients have enrolled in the trial. 

Phase 1 clinical trial in Diabetic Foot Ulcer

Recruitment for Phase 1 trial in diabetic foot ulcer continues in Australia. The trial has experienced lower enrolment rates because many potential patients were not able to meet the eligibility criteria. 

The company has taken steps to address this, including opening additional clinical centres and updating the protocols. 

Phase 1 clinical trial in Renal Transplant

Cynata has engaged with Leiden University Medical Center (LUMC), the Netherlands, to initiate the proposed Phase 1 clinical trial focused on renal transplant. Trial funding and management will be undertaken by LUMC while Cynata will supply CYP-001 for the trial. The regulatory approval process is underway, and outcomes are expected this quarter.

CYP shares were trading at AU$0.135 at the time of writing on 24 July 2023.