CYP 2021 - The year ahead, page-5

Nice work, good to start a fresh thread for 2021.

Expanding the clinical development pipeline Cynata has carefully selected additional target indications for further clinical development, following
a comprehensive scientific, clinical and commercial review. The target indications, including IPF, renal transplantation and DFU, represent a combined market opportunity in excess of A$20bn p.a.

Preparation activities are now underway to advance clinical programs in these high priority target indications including (but not limited to): trial design, regulatory consultation, endpoint selection, key opinion leader engagements and clinical site selection. The Company will continue to develop its existing clinical product pipeline in addition to these new targets and will continue to drive its partnering strategy. Further background information on the new target indications is provided below.

Idiopathic Pulmonary Fibrosis (IPF)
IPF is an incurable disease of unknown cause, which results in extensive scarring (or fibrosis) of the lungs. When first diagnosed, lung damage is often advanced and invariably progresses to respiratory failure with only 20% to 30% of patients surviving five years after diagnosis
.Treatment of IPF represents a significant unmet medical need, with existing therapies having limited effects on disease progression and survival rates. Studies conducted in preclinical rodent models of IPF demonstrated efficacy of Cymerus MSCs, based on statistically significant improvements in multiple clinically relevant outcome measures, including levels of fibrosis, inflammation, dynamic lung compliance and airway resistance.

Renal Transplantation (Kidney)
Renal transplantation is a common treatment for end-stage kidney disease, where the kidneys are no longer able to function and a transplant is required to eliminate patients’ reliance on dialysis.
Following a kidney transplant, the body may recognise the transplanted kidney as foreign tissue and attempt to protect the patient by attacking it. In preclinical studies, Cymerus MSC treatment demonstrated effects expected to minimise or prevent organ transplant rejection.

Diabetic Foot Ulcer (DFU)
DFUs are sores on the feet of patients with diabetes and are among the most common complications occurring in 15% to 25% of patients sometime during their lifetime . Severe ulcers can lead to hospitalisation and lower limb amputation if not treated in a timely manner. Cymerus MSCs have
achieved encouraging efficacy results in a preclinical model of diabetic foot ulcers. This provides strong support for the inclusion of this new indication to Cynata’s clinical development pipeline.


3x more Phase 2 trials on the way.