The company said that Davunetide’s potential as a treatment for PSP was confirmed in both animal studies and phase II human clinical trials in patients with amnestic mild cognitive impairment (aMCI).
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. 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.
“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.
“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.”
The company said that it’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. The trial will help validate the design and prepare for a larger phase II clinical trial that the company intends to initiate in 2010.