Aeolus Pharmaceuticals took a major step forward toward development of a drug to fight Lou Gehrig’s Disease on Tuesday.
The company announced that it had received approval from the Food and Drug Administration for its investigational new drug application and can now proceed with Phase 1 clinical trials in humans.
Lou Gehrig’s Disease, or amyotrophic lateral sclerosis (ALS), affects 30,000 Americans at any given time, according to the ALS Association. There is no cure for the disease, which was first described in 1869 and was first widely publicized when the New York Yankee star Lou Gehrig was afflicted in 1939.
“Allowance of our (application) for ALS by the FDA is a tribute to the quality of work by Aeolus’ development team that went into the (application) submission, and to the impressive preclinical data for AEOL 10150,” said James Crapo, the company’s CEO. “Successful development of AEOL 10150 could offer an effective new option to the patients and families that suffer from ALS and the physicians who treat them.”
Aeolus said it is negotiating with clinical centers about launching the trial. The first trial will include a single dose of the drug to evaluate safety, tolerability and the impact of the medication.
Aeolus is a neurodegenerative disease and is usually fatal within five years.