FDA grants Orphan Drug Status to Allon’s davunetide for brain disease

13-Jan-2010 - Canada

Allon Therapeutics Inc. announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to the Company’s lead neuroprotective drug candidate davunetide for the treatment of Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.

Gordon McCauley, President and CEO of Allon, said Orphan Drug Designation brings additional commercial benefits to the Company’s program to develop davunetide to become the first approved treatment for a disease often mis-diagnosed as Parkinson’s or Alzheimer’s disease.

“PSP is devastating for thousands of middle-age patients and their families,” said McCauley. “Meeting the desperate need for a treatment is a significant business opportunity for Allon made more attractive by the FDA’s Orphan Drug Designation for davunetide.”

McCauley said Allon has demonstrated a strong scientific and clinical rationale for the potential efficacy of davunetide in PSP. “The pathology of PSP and Alzheimer’s is similar in that both diseases involve impairment of the brain protein tau — and we have shown that davunetide is the most advanced tau therapy in the world.”

McCauley said davunetide’s potential as a treatment for PSP was confirmed in both animal studies and Phase II human clinical trials with patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s.

“Our research has shown that davunetide reduced tau impairment and preserved memory in mice bred to replicate Alzheimer’s or PSP tau pathology. In addition, our Phase II clinical trials have shown that davunetide can also improve memory function in aMCI patients.”

Allon’s clinical program in this area is expected to begin shortly with a Pilot trial treating a small number of patients with tau impairments, including PSP. This trial will help validate the trial design and prepare for a larger Phase II clinical trial that the Company intends to initiate in 2010. Trial investigators are among the leading experts in the field, including Drs. Bruce Miller and Adam Boxer of the Memory and Aging Center of the University of California, San Francisco.

https://www.bionity.com/en/news/111700/fda-grants-orphan-drug-status-to-allons-davunetide-for-brain-disease.html