Holte, Denmark, March 29, 2010 Action Pharma A/S has completed dosing in the second phase II clinical trial with its leading development candidate, AP214. Interim efficacy data are expected June 2010. AP214 is being developed for protection of acute kidney injury in patients undergoing cardiac surgery under cardiopulmonary bypass as the lead indication.
“Completing the dosing ahead of schedule in the phase II clinical trial is a major milestone for Action Pharma”, says Ingelise Saunders, CEO of Action Pharma. She continues, “it also represents an important step forward in our partnering and corporate development strategy.” The clinical trial is a randomized, double-blind, placebo-controlled, dose-finding, phase II trial in 42 patients undergoing cardiac surgery under cardiopulmonary bypass. Key unblinded results are expected in June 2010 while full unblinded data are foreseen in Q3 2010.
“Many patients in the USA and Europe each year undergo major thoracic surgery, and approximately 10-20% of these patients experience various degrees of kidney injury which again are associated with increased mortality, co-morbidity and prolonged hospitalization. Currently, no treatment is available. Thus, this indication addresses a major unmet medical need, and we expect the commercial potential to be approximately EUR 500 million with expansion potential in additional indications”, says Søren Nielsen, COO of Action Pharma. The clinical trial has been conducted in Denmark at the Department of Cardiac and Thoracic Surgery at Rigshospitalet (the Danish State Hospital) in Copenhagen, and at Odense University Hospital in Odense, respectively.
AP214 is a new first-in-class drug candidate with a novel mode of action. It mediates its action through new pharmacological targets, the melanocortin receptors. AP214 is expected to reduce the inflammatory response as well as post-surgical reperfusion injuries, factors known to cause kidney injury. Initial results from an earlier phase II clinical trial in the USA and from a phase IB clinical trial in human volunteers subjected to LPS-induced inflammation, revealed positive effects of AP214.
“Based on these studies, and additional phase I and preclinical results, we conclude that AP214 is safe and well tolerated, and is a potent drug candidate to treat or prevent organ injury. We have a clear path forward and the approved drug could reach the market in 2014”, adds Søren Nielsen.
About Action Pharma A/S
Action Pharma is a privately owned Danish biotech company. Action Pharma develops novel drug candidates targeting melanocortin receptors and bring these to the stage of clinical proof of concept for subsequent partnering. The drug candidates are first in new drug classes and exploit novel mode of action profiles with an efficacy that is superior compared to compounds currently on the market. Action Pharma has a pipeline of several patent protected, in-house developed, drug candidates. Two drug candidates are currently in clinical development, AP1030 (completed phase IB) and AP214 (in phase II), and two drug candidates in late preclinical development. The Action Pharma team has significant scientific expertise and has published more than 400 scientific papers.
AP214 is developed to prevent post-surgical kidney injury after major thoracic surgery. AP214 is currently being tested in a phase II clinical trial investigating the effect of AP214 on organ protection in patients undergoing cardiac surgery, who are at increased risk of kidney injury. Every year, more than 150,000 patients in the USA and in the EU undergo major thoracic surgery. Approximately 10-20% of these patients experience various degrees of kidney injury which again is associated with marked increase in mortality, co-morbidity and prolonged hospitalization. Currently, there is no treatment to prevent or treat kidney injury associated with major surgery. Thus there is a major unmet medical need. AP214 mediates its potent effect via the type 1 and type 3 melanocortin receptors. Initial results from an earlier phase II US clinical trial and from a phase IB trial in human volunteers subjected to LPS-induced inflammation, revealed positive effects of AP214.
AP1030, the lead compound within the Company’s small molecule program, has potent preclinically documented anti-diabetic and anti-obesity effects. AP1030 is currently in clinical development in obese individuals and has completed a two-week phase IB clinical trial with positive effects on glucose metabolism. AP1030 has the potential to be superior to other antidiabetics, including GLP-1 analogues, DPP-4 inhibitors and glitazones. Importantly, AP1030 can be administered orally (once daily) in contrast to GLP-1 analogues. Moreover, the marked weight reducing effects of AP1030 observed in non-clinical pharmacodynamic models contrast the absence of weight reduction by other orally available anti-diabetics, including DPP-4 inhibitors. Thus, this makes AP1030 highly attractive in the market for type II diabetes associated with obesity. The mode of action of AP1030, first in its drug class, involves a central melanocortin type 4 receptor mediated effect, thereby modulating appetite and central regulation of glucose metabolism plus a systemic anti-inflammatory melanocortin type 1 receptor mediated anti-diabetic effect aimed at reverting low grade inflammation in fatty tissue, and thereby reducing peripheral insulin resistance.
In addition, Action Pharma develops AP1189, an oral treatment of systemic inflammatory diseases such as rheumatoid arthritis and inflammatory bowel diseases. Similarly, AP405 is developed for topical treatment of inflammatory skin diseases, such as atopic dermatitis. Action Pharma has a strong investor base of leading European investors, including Sunstone Capital, Global Life Science Ventures, InnovationsKapital, SLS Invest, Inventure Capital, and Oestjysk Innovation. For more information, please visit www.actionpharma.com
