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ProtAffin AG Releases New Preclinical Data for Lead Anti-inflammatory Product PA401 in Inflammatory Lung Disease


5/22/2012 10:02:08 AM

Graz, Austria and London, UK- 22nd May 2012: ProtAffin AG, a biotechnology company developing a novel class of next-generation biopharmaceuticals for respiratory disease, inflammation and oncology, today announced additional preclinical data in models of neutrophilic lung inflammation for its novel product PA401 at the American Thoracic Society (ATS) Conference in San Francisco.

ProtAffin presented the data in a poster in the session “Regulation of lung inflammation” at the conference, which is the largest gathering of scientists and clinicians in the respiratory community in the US. The preclinical model of neutrophilic lung inflammation showed that PA401 reduced the levels of four pro-inflammatory chemokines in plasma, as well as the levels of four additional proteins of clinical relevance to the development of chronic lung inflammation. This additional preclinical data highlights the broad, potent and novel anti-inflammatory effects of PA401 in standard models of lung inflammation. To see the data in detail, please download the ATS poster through this LINK.

PA401 is a modified form of the human chemokine IL-8 that has anti-inflammatory properties. Human IL-8 (CXCL8) is a chemokine produced by macrophages and other cells and its primary function is the attraction of neutrophils to sites of acute and chronic inflammation. PA401 has been shown to be a potent, targeted anti-inflammatory protein preventing the infiltration of neutrophils which are a hallmark of many respiratory diseases including chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).

Dr. Mike Bartley, Chief Development Officer of ProtAffin, commented: “We are very happy to release additional preclinical data that confirm the previously observed broad anti-inflammatory effects of our product candidate PA401 in a preclinical model of neutrophilic lung inflammation. In this preclinical efficacy model we have identified a clear reduction of 8 biomarkers of lung inflammation. We look forward to starting the clinical development of PA401 very soon, in which we will explore the broad potential of PA401 in steroid-resistant inflammation in serious lung diseases, a key area of unmet medical need.”

About ProtAffin AG

ProtAffin AG is a European biotechnology company that has developed a new technology for generating biopharmaceuticals addressing many of the highest priority disease targets in the Pharmaceutical Industry. The CellJammer® discovery technology generates biopharmaceuticals that cause potent down-regulation of protein function. By developing biopharmaceuticals which bind glycans, ProtAffin avoids many limitations of established drug modalities, such as monoclonal antibodies and small molecules. The approach is applicable to 900 targets contained in our proprietary database, including chemokines and growth factors. The Company has applied its technology to generate drug candidates in the field of inflammation, respiratory and oncology.

The lead candidate generated by the platform is PA401, an anti-inflammatory protein derived from IL-8. PA401 is a small biopharmaceutical which has shown outstanding preclinical efficacy in models of neutrophilic lung inflammation including COPD, which may translate into PA401 having a superior efficacy and safety profile versus competitors on the market and in development. PA401 is in late preclinical development and a Phase 1 study is scheduled to start in Q2 2012. ProtAffin’s pipeline also contains a modified form of MCP-1, which potently blocks macrophages in a number of inflammatory and oncology settings, and a modified SDF-1a, a protein implicated in fibrotic lung disease and ophthalmology.

ProtAffin has raised €19 million in venture funding from an international consortium of leading European and North American investors and €6m non-dilutive grant financing. ProtAffin is located in Austria and the UK.

About PA401

ProtAffin’s lead anti-inflammatory product is PA401, a modified form of the human chemokine IL-8. Human IL-8 (CXCL8) is a chemokine produced by macrophages and other cells and its primary function is the induction of chemotaxis in neutrophils. PA401 acts as a potent, targeted anti-inflammatory protein preventing the infiltration of neutrophils which are a hallmark of many acute and chronic respiratory diseases including chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF). PA401 has recently been shown to reduce the levels of four chemokines (KC, IP-10, MCP-1 and MCP-5) as well as 4 other biomarkers relevant to lung disease (VEGF, ET-1, TIMP-1 and SCF) in an LPS-induced model of lung inflammation in mice.

By binding to glycans that drive the infiltration of neutrophils in inflammation with a higher affinity than wild-type IL-8, PA401 can prevent wild-type IL-8 from activating neutrophils and inhibit the events that would normally lead to chronic lung inflammation. A patent encompassing PA401 and other IL-8 variants was granted to ProtAffin in the USA and EU in 2009.

PA401 is in preclinical development for COPD, CF and related respiratory indications. COPD represents the 4th leading cause of death in the western world and is an underserved pharmaceutical market in excess of $11 bn per year. Cystic Fibrosis is the most common life-threatening genetic disease in Europe and the US. A key aspect of lung damage in patients with CF is related to the permanent damage done to lung tissue due to an underlying chronic inflammation caused by high IL-8 levels and neutrophilic inflammation.

PA401 is a novel biopharmaceutical product in preclinical development representing a huge commercial opportunity by addressing the significant unmet medical need in respiratory diseases where chronic neutrophilic infiltration is present, including COPD, exacerbations of COPD, cystic fibrosis and bronchiectasis. PA401 has also been granted Orphan Drug designation in the US and EU for the “prevention of delayed graft function after solid organ transplantation”.

Contacts

Dr. Mike Bartley, Chief Development Officer

ProtAffin AG

Impulszentrum Graz-West

Reininghausstrasse 13a

A-8020 Graz, Austria

T: +43 316 382 541

F: +43 316 382 541-4

E-mail: mbartley@protaffin.com

Web: www.protaffin.com

For media enquiries:

College Hill Life Sciences

Dr. Robert Mayer

Tel: +49 89 5238 8030

Email: robert.mayer@collegehill.com



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