ProtAffin starts Phase 1 study in inflammatory lung disease
ProtAffin AG starts Phase 1 study for lead product PA401 in inflammatory lung disease
Graz, Austria and London, UK- 27th June 2012: ProtAffin AG, a biotechnology company developing a novel class of next-generation biopharmaceuticals for respiratory disease, inflammation and oncology, today announced that it has started dosing healthy volunteers in a Phase 1 clinical study in the UK with its novel investigational anti-inflammatory product, PA401.
PA401 is 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 attraction of neutrophils to sites of acute and chronic inflammation. PA401 acts as a potent, targeted anti-inflammatory protein preventing the infiltration of neutrophils which is 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 pleased to have received approval from the MHRA in the UK to initiate our first human study with PA401. Our extensive preclinical studies into the anti-inflammatory properties of PA401 suggest that it is a promising candidate for the steroid-resistant inflammation which causes significant morbidity and mortality in diseases such as COPD and cystic fibrosis. We expect to complete the study by the end of 2012.”
Dr. Jason Slingsby, Chief Executive Officer of ProtAffin, added: “Starting the Phase 1 study for PA401 is a major milestone for the Company, and marks ProtAffin becoming a clinical-stage biotechnology company. PA401 was discovered using ProtAffin’s proprietary CellJammer® discovery platform. Gaining experience in clinical development will add considerable value to this unique, differentiated biologics platform for down-regulating protein activity in diseases with severe unmet medical disease and mortality. We are confident that we will establish targeting glycans with biopharmaceuticals as a new therapeutic modality within the biopharmaceuticals industry.”
Notes to Editors:
About ProtAffin AG
ProtAffin AG is a clinical stage 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 over 900 protein targets contained in its proprietary GlycAffiBase™ database. The Company has applied its CellJammer® discovery 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 which has recently entered a Phase 1 clinical study. ProtAffin’s pipeline also contains a modified form of MCP-1 (CCL2), which potently blocks macrophages in a number of inflammatory and oncology settings, and a modified SDF-1α (CXCL12), 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.
PA401 is a 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.
By binding to glycans 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 infiltration of neutrophils and chronic lung inflammation. PA401 is the first differentiated biological product generated by the Company’s CellJammer® discovery technology. A patent encompassing PA401 and other IL-8 variants was granted to ProtAffin in the USA and EU in 2009.
PA401 is in clinical 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 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”.
Dr. Mike Bartley, Chief Development Officer
A-8020 Graz, Austria
T: +43 316 382 541
F: +43 316 382 541-4
For media enquiries:
College Hill Life Sciences
Dr. Robert Mayer
Tel: +49 89 5238 8030
ProtAffin starts Phase 1 study in inflammatory lung disease 0.00 kb (en)