The story around Amira Pharmaceuticals’ experimental drug AP2966 is beginning to get interesting. Yesterday the San Diego-based respiratory drug company said its experimental drug reduced lung scarring in mice, offering promise that the oral medication might one day be approved to treat pulmonary fibrosis. But it turns out there may be a lot more to this drug.
Dr. Andrew Tager, a pulmonologist at Massachusetts General Hospital in Boston and a scientific advisor to the company, said AP2966 shows promise against other fibrotic conditions, such as cirrhosis of the liver and some forms of kidney disease. That could make AP2966 a much bigger deal.
Amira already has conducted animal studies pitting AP2966 against pirfenidone, its closest potential competitor. Pirfenidone is approved treat pulmonary fibrosis in Japan and InterMune of Brisbane, Calif. plans to seek FDA approval for the drug. Tager said the Amira drug was superior to pirfenidone in animal models of pulmonary fibrosis and equivalent to pirfenidone in animal models of cirrhosis of the liver.
“The data is very impressive,” Tager said. “As far as what’s out there, this is one of the most promising.”
Amira’s drug targets a receptor called LPA1 that plays a role in inflammation and wound healing. Tager said that it is thought that in some people the receptor has an “over-exuberant response” to injury, which leads to a build up of scar tissue. Tager was the first to connect this receptor to pulmonary fibrosis in a paper published in Nature Medicine last year. He reported that mice lacking an LPA1 gene did not develop lung scarring when exposed to a chemical trigger.
It is still early days for AP2966. Amira CEO Bob Baltera said the company must complete toxicology studies and manufacturing work before it can initiate human tests, which the company hopes to begin during the first half of 2010. Baltera said animal studies did not point to any serious safety concerns. “The data looks clean and the animals look healthy,” he said. “But you never really know until you do the studies in patients.”
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