Clinical-stage drug development company Invion Limited (ASX:IVX) today announced the submission of an Investigational New Drug application (IND) to the U.S. Food & Drug Administration (FDA) for INV103 (ala-Cpn10), a modified version of the naturally occurring human protein, chaperonin10.
If accepted, the IND will enable Invion to begin phase II clinical studies in patients with systemic lupus erythematosus (SLE or lupus).
The submission follows the company’s pre-IND meeting with the FDA on 14 December 2012.
“The submission of this IND with the FDA is a major milestone for the company and a testament to our team’s determined efforts to progress this program. Led by Dr Mitchell Glass, the Invion team has moved swiftly to pre-IND and then IND stage, and are now focussed on the next step in the development path for this drug,” said Dr William Garner, Chief Executive Officer.
“If granted, the lupus IND will be the second IND that Invion is working under to develop its assets. This is a significant achievement for a company of our size and operational leanness”, he said.
The submission of the lupus IND is the 50th IND submission for Chief Medical Officer, Dr Mitchell Glass, who has received marketing authorisation for 5 New Drug Application (NDA) submissions with the FDA.
“We believe the data to date clearly demonstrates that the investigation of INV103 as a therapy for lupus is warranted, and we look forward to continuing our work to elucidate clinically meaningful results for this drug,” Dr Glass said.
About INV103 (ala-Cpn10): Target Product Profile
INV103 (ala-Cpn10) is a modified version of the natural human protein, chaperonin10, which has biological activity ideally suited to the treatment of inflammation associated with autoimmune disease. IL-6 is a marker of vascular inflammation, and with INV103 clinical data to date that includes a significant reduction in biomarkers of inflammation including serum IL-6, INV103 is targeted as a potential new therapy in the under-serviced lupus market.
Lupus is a vascular inflammatory disease that leads to chronic inflammation, antibody production, and tissue damage. The disease occurs more commonly in women and increases risk of other health problems including heart disease, kidney disease and osteoporosis. In March 2011, the FDA approved the first new drug for lupus in more than 50 years which is both a reflection of the complexity of the disease and a clear indication of a major unmet clinical need. The lupus drug market is predicted to reach sales of over $4B in the US and five major EU markets by 2020.
About the Clinical Trial Protocol
The Protocol as submitted is entitled a “Double-blinded, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and biochemical activity of intravenous ala-Cpn10 administration in subjects with SLE.” The Protocol Number is IVXCpn001. The primary objective is to evaluate the safety, tolerability and efficacy of four-week treatment with Cpn10 in subjects with mild SLE. The adverse event profile and safety laboratory parameters will be monitored throughout the study. The primary outcome measure is the reduction from baseline serum IL-6 levels at the end of active dosing, comparing treatment to placebo cohort. Secondary outcome measures include safety and toxicity, pharmacokinetics (PK) and an assessment of anti-drug antibodies (ADAs). Exploratory endpoints include Safety of Estrogens in the Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score; pharmacodynamics (PD) (serum biomarkers correlated with disease activity and the inflammatory response of patient immune cells); and changes in other serologic measures including autoantibodies and indicators of systemic inflammation and vascular damage. Details of this clinical trial can be found at www.clinicaltrials.gov with the identifier: NCT01838694.
About the Clinical Trial site and Principal Investigator
The Altoona Center for Clinical Research (ACCR) is a privately owned, 40,000 square foot state-of-the-art research and group private practice facility located in Duncansville, Philadelphia. ACCR is dedicated to providing quality clinical research with the highest standards of patient safety. Over 740 studies have been completed at the center for at least 100 different Sponsors and CRO’s. The Center was founded in 1991 by Alan J. Kivitz, MD, CPI. Dr. Kivitz is a Certified Physician Investigator and a member of the Osteoporosis & Arthritis Investigator Networks. Dr Kivitz and his team of rheumatologists have a combined 48 years of clinical research experience. All four physicians are Board Certified in Rheumatology and Internal Medicine.
About Invion Limited
Invion is a clinical-stage drug development company focussed on the development of treatments for major opportunities in the inflammatory diseases market including asthma and COPD ($34B) and lupus (to $4B)i. The Company’s strategy is for the cost-effective development of its assets to late phase II before negotiating commercial partnerships. Invion has two phase II proprietary therapeutic candidates: INV102 (nadolol), a beta blocker being repurposed to treat inflammatory lung conditions; and, INV103 (ala-Cpn10), a modified human protein being targeted to the treatment of autoimmune inflammation. These assets are in phase II clinical programs in chronic bronchitis (smoking cessation), asthma and systemic lupus erythematosus (lupus). Medical, regulatory and commercial precedent, as well as existing phase II data, supports Invion’s development strategy which is being carried out under an experienced management team including Dr Mitchell Glass who has filed five 50 INDS and 5 NDAs with the FDA. Invion’s strategic partners include the United States National Institutes of Health (NIH) which is funding the phase II asthma program in excess of $4 million (non-dilutive). This is an exciting validation by one of the most prominent medical research bodies in the world.