Invion commences phase II clinical trial in lupus

Invion (ASX:IVX) has commenced patient enrolment in the company’s phase II clinical trial of INV103 in patients with mild systemic lupus erythematosus (lupus).

INV103 is based on the naturally occurring protein chaperonin10, which is present in all cells and thought to function as a natural regulator of the innate immune system. The study aims to generate data on the safety, tolerability and efficacy of INV103 as a potential therapy for lupus - an autoimmune connective tissue disease that can affect any part of the body.

The clinical trial is being carried out at sites in Pennsylvania and Texas in the US. It is being conducted under an investigational new drug (IND) application with the US FDA, which Invion submitted earlier this year. Only one drug has been approved by the FDA for the treatment of lupus over the last 50 years.

Four cohorts of eight patients will be treated under the trial. It is expected to run for approximately 12 months, with safety and efficacy data from the first two cohorts available in around six months.

Invion CEO and Managing Director Dr Greg Collier said the commencement of the trial “represents a major milestone for the company. The complex lupus treatment market has been clinically underserved, and positive data from this trial would deliver a promising lead on a potential future therapy.”

Invion was formed almost a year ago after a merger between Brisbane-based CBio with US-based Inverseon.

Its shares were trading 2.86% higher at $0.036 as of 11 am on Friday.