ORBCELTM Clinical Development

Diabetic Foot Ulcers

Non-healing neuropathic foot ulcers in patients with diabetes develop due to distal sensory loss. The current standard care involves (i) removal of pressure from the ulcer, (ii) restoration of blood flow if peripheral vascular disease is present, (iii) debridement of the ulcer, and (iv) antibiotic therapy to control infection. On average, standard care results in only 30% healing after 20 weeks of treatment, therefore there is a critical clinical need to develop novel therapies for treatment of non-healing diabetic ulcers in order to prevent amputation and reduce the significant drain on healthcare budgets and burden on an individual’s health. In pre-clinical models of non-healing diabetic wounds, a single topical application of ORBCEL™ in a collagen matrix significantly improved wound closure. The safety/feasibility of topical ORBCEL™ will be assessed in the REDDSTAR Phase 1b clinical trial.

NEPHSTROM  Diabetic Kidney Disease EU Clinical Trials Register

Acute Respiratory Distress Syndrome – ARDS

ARDS is a devastating critical care syndrome characterized by pulmonary oedema, respiratory failure and multiple organ failure. Sepsis and pneumonia are the most common causes of ARDS and lead to the worst outcome. Mortality rates approach 40% at 28 days. ARDS represents a major burden to critical care and annually affects approximately 400,000 – 500,000 patients in Europe, the United States and Japan alone. There are no currently approved or effective pharmacological therapies for ARDS. A single dose of ORBCEL™ has been demonstrated to significantly improve lung oxygenation, reduce inflammation, reduce oedema and reduce bacterial infection in a series of pre-clinical experiments. ORBCEL™ will be tested for safety, feasibility and efficacy in the Phase 1/2 REALIST clinical trial.

REALIST ARDS ClinicalTrials.gov

Diabetic Kidney Disease – DKD

Diabetic nephropathy (also known as diabetic kidney disease) is a progressive disease caused by damage to the blood vessels in the kidney and is associated with long term, uncontrolled diabetes. The disease is characterized by failure of the kidney to filter out protein which leads to scarring of the glomeruli. DKD is the prime reason for dialysis and kidney transplantation in many developed countries. Patients usually succumb to associated cardiovascular disease, or progress to end stage renal disease which has a mortality rate similar to many cancers. There have been no new therapies approved for DKD in the last 20 years. In preclinical chronic models of DKD, a single dose of ORBCEL™ significantly improved the filtration rate of the kidney whilst reducing damage to the glomeruli, reducing proteinuria and inflammation. The safety, feasibility and efficacy of ORBCEL™ will be assessed in the NEPHSTROM Phase 1/2 clinical trial.

NEPHSTROM Diabetic Kidney Disease ClinicalTrials.gov

Primary Sclerosing Cholangitis – PSC

Primary Sclerosing Cholangitis is a chronic immune mediated liver injury of unknown cause, with a natural history of progression to liver failure. PSC does not respond to classic immunosuppressants and there are no current therapies. PSC have been observed in all heritages and accounts for more than 10% of all liver transplants. In three distinct models of inflammatory liver injury, a single dose of ORBCEL™ improves liver function and reduces inflammation. The safety, feasibility and preliminary efficacy of ORBCEL™ will be assessed in the MERLIN Phase 1/2 clinical trial.

MERLIN  PSC and AiH ClinicalTrials.gov