Amicus puts hold on clinical trial of muscle disorder drug
POSTED March 1, 2009 - 21:56 | POSTED BY Jaspreet Kaur
Last edited by Shikha Patial on March 2, 2009 - 10:18
Bangalore, March 1: Amicus Therapeutics Inc. (NSDQ: AMCS), has come under the spotlight after it had to put a halt on the mid-stage trial of its new treatment for an uncommon muscle disorder. This had to be done after two patients suffered grave consequences of the treatment.
This incident has seriously affected the company’s shares as they tumbled to an all time low of 34 percent. The company’s stock was among the top intraday losers on NASDAQ.
Lazard Capital Markets analyst Matthew Osborne, who was confident about the other two mid-stage studies, was quoted as saying, “It was a surprise to see these adverse events, but there is still an opportunity to demonstrate safety and activity for other diseases.”
As of now, patient enrolment for the mid-stage clinical experiment has been stopped by Amicus.
The condition of the two patients became serious probably due to the treatment associated with the drug AT2220. This was revealed by the site investigator who looked into the current event.
The latest trial was done in order to determine the safety and acceptability of different dosing patterns of AT2220 over a period of 12 weeks. The patients on whom the trial was conducted suffered from an unusual muscle disorder known as Pompe disease. 18 such patients were taken into account.
However, Pacific Growth Equities analyst Gregory Wade was amazed at such a high sell-off in the shares. He said that the position of the company depends on the other two mid-stage programs.
Amicus too added that the present spate of events would not have any effect on its ongoing studies, which involve two more drugs. These drugs are namely, Amigal and Plicera. While the former is being developed for the treatment of Fabry disease, the latter is under development for treating Gaucher disease.
Assuring immediate action in this regard, Chief Executive John Crowley said, “We will work closely with the investigators and the U.S. Food and Drug Administration to address these issues, modify the protocol as appropriate, and get the trial back on track as quickly as possible.”
