Dec. 15 (Bloomberg) -- Sygnis Pharma AG’s experimental AX200 protein-based treatment for strokes failed to meet the primary goal of a mid-stage study, after a trial of the medication showed no difference for people treated with placebo.
“The study recorded no clinical improvement and did not show any statistically significant difference,” the company said in a statement today. “Sygnis Pharma will continue to analyze the current data set and the new data that will become available in the weeks ahead.”
The trial was based on 328 patients in Europe, the company said. The drug is the Heidelberg, Germany-based biotechnology company’s only product in development. Sygnis decided in October 2010 to cut its workforce in half as it adopted a strategy focused on getting AX200 to market.
AX200 is a protein that enhances the body’s production of a substance that helps it respond to damage to the brain. Researchers studied the drug’s efficacy in stopping nerve-cell death and regenerating damaged tissue within hours of an acute stroke. It was given to patients over a three-day period at 70 centers across eight countries in Europe. The last patient completed treatment Nov. 2, the company said.
Dietmar Hopp, the co-founder of business-software maker SAP AG who is Sygnis’ biggest investor, agreed in June to provide funding for the company to complete the trial and continue operations through the end of 2012.
Bigger drugmakers including AstraZeneca Plc have failed to develop treatments for strokes, which occur when blood supply to the brain is interrupted by a clot or burst vessel. About 15 million strokes are reported annually worldwide, with 5.5 million deaths, according to World Health Organization figures.
“The top line data should be important in terms of the strategy of the company,” Igor Kim, an analyst with Close Brothers Seydler Research AG, said in an interview before the AX200 trial results were disclosed.
The treatment is made from a living organism and considered a biologic, which is more difficult and costly to develop than a drug based on a chemical reaction, Kim said.
--Editors: Ben Livesey, Andrew Pollack
To contact the reporters on this story: Allison Connolly in Frankfurt at firstname.lastname@example.org; Niklas Magnusson in Hamburg at email@example.com
To contact the editor responsible for this story: Phil Serafino at firstname.lastname@example.org