Allon Therapeutics’ lead neuroprotective drug candidate, davunetide, has been granted Fast Track status from the U. S. Food and Drug Administration (FDA) for the treatment of Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.
Fast Track status is designed to facilitate development and expedite review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need.
Gordon McCauley, President and CEO of Allon, said the Fast Track status is an important milestone for the Company and validation of the desperate need for therapies in this debilitating disease where davunetide has such potential.
“Fast track status provides for early and frequent communication between the FDA and Allon to resolve questions and issues quickly,” said McCauley. “It will ensure that we work with the FDA to gather the critical data needed for approval.”
Fast Track also provides for “rolling submissions” in which sections of a new drug application (NDA) can be submitted and reviewed as they are completed rather than the typical process in which review begins only after the submission of the last section. Additionally, Allon may request that davunetide be considered for priority review, and if accepted would result in a six-month review instead of the standard ten-month review.
Allon announced January 12, 2010 that the FDA has granted Orphan Drug status to davunetide for the treatment of PSP treatment in the United States.
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 davunetide is the most advanced tau therapy in the world.
Research has shown that davunetide reduced tau impairment and preserved memory in mice bred to replicate Alzheimer’s or PSP tau pathology.
In 2008, Allon reported Phase IIa clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer’s Disease and Related Disorders (ICAD 2008).
On December 7, 2009, Allon reported Phase IIa clinical trial results showing that davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. The data was presented at the annual meeting of the American College of Neuropsychopharmacology. Further, on March 30, 2010 Allon released top-line results from a schizophrenia imaging sub-study showing that 12 weeks of treatment with davunetide resulted in a statistically significant increase in levels of a biomarker that is an important indicator of brain cell health.
Allon announced commencement of its PSP clinical program January 26, 2010 with a pilot clinical trial sponsored by the Memory and Aging Center of the University of California, San Francisco (UCSF). This pilot clinical study, enrolling approximately 12 patients, will help Allon and its clinical collaborators validate the trial design and prepare for a larger Phase 2 PSP clinical trial scheduled to begin this year. Trial investigators are among the leading experts in the field, including Drs. Bruce Miller and Adam Boxer of the Memory and Aging Center.
On March 11, 2010 Allon announced completion of a Phase 1 clinical trial that began enrolling patients January 28, 2010. The resulting data expanded the demonstrated safety range and pharmacokinetic profile of davunetide at dosage levels higher than previously used in the Company’s clinical trials. This data will help set the dosing range for the larger Phase 2 PSP clinical trial scheduled to begin this year.
Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s laboratory and animal studies have shown that davunetide restores the function of structures in the brain — known as microtubules — which are critical to communication between brain cells and the structure of individual cells.
Date: April 6, 2010
Source: Allon Therapeutics