Invion to submit IND for lupus treatment in 2013

Invion (ASX:IVX) will progress its lupus treatment, INV103, through clinical trials and will submit an investigational new drug (IND) application with the US Food and Drug Administration (FDA) in early 2013.

The company met with the FDA on 14 December to discuss the roadmap for the drug and the FDA agreed to its proposed indication of systemic lupus erythematosus, or SLE, noting that it was an important unmet medical need.

The FDA also gave a tick to Invion’s clinical strategy, subject to a review of the final clinical trial protocol which will be provided with the IND submission next year.

Stocks of INV103 have been transferred to Laureate Biopharmaceutical Services USA in New Jersey where they will be qualified, formulated and filled for release to support a proof-of-concept clinical trial in lupus.

“Our meeting with the FDA represents an important step in our clinical development plan for INV103,” said Dr William Garner, Invion Chief Executive Officer.

“Our strategy to bring this drug into human clinical trials for patients suffering from lupus is now clear, and we aim to submit an IND early in 2013. If granted this will be the second IND that Invion is working under to develop its assets.”

INV103 is based on a naturally occurring protein, chaperonin10, which is present in all cells. It is thought to function as a natural regulator of the innate immune system.

Administering the protein can help regulate inflammation, and can potentially be used to treat inflammatory diseases such as lupus and rheumatoid arthritis.

“INV103 is a fascinating protein. We believe the clinical, safety and biological data obtained to date demonstrate characteristics which warrant investigation of this drug as a therapy for lupus, and we are very pleased to have achieved clear FDA support for our plan as well as acceptance of our rationale for our strategies in chemistry, pharmacology, toxicology and clinical development," said Dr Mitchell Glass, Chief Medical Officer.

Invion came out of the merger of CBio and US-based Inverseon, which was completed in September. INV103 was Inverseon’s lead product prior to the merger.

Invion (ASX:IVX) last traded at 4.7c.