Canadian company Allon has the farthest advanced anti-tau drug, AL-108, in the Alzehimer space. They will try to find a partner before launching a large PII in Alzheimer's. The drug failed a small PII in CABG cognitive problems this summer, and is currently in another small PII for schizophrenia-related cognitive dysfunction.
Allon Therapeutics announces milestones for 2009
VANCOUVER — January 12, 2009 - Allon Therapeutics Inc. (TSX: NPC) announced today its 2009 milestones and confirmed that the Company’s existing cash resources are sufficient to fund its business into 2011.
Gordon McCauley, President and CEO of Allon, said, “The Company takes the establishment and achievement of milestones very seriously with the same focus it places on prudent management of cash resources. We are proud of the fact that we have substantively achieved our past milestones and are in a strong cash position today.”
McCauley said the most significant milestone not yet achieved is the establishment of a pharmaceutical partnership for the Company’s Alzheimer’s disease (AD) program. “We are continuing commercial partnership discussions with several pharmaceutical companies and expect to successfully conclude a partnership in 2009.”
“A number of pharmaceutical companies have confirmed they are keenly interested in our neuroprotection drugs and technology but 2008’s international financial crisis pushed these partnership decisions into 2009,” McCauley said. Given the state of these negotiations, the Company will initiate a Phase IIb study in AD after a partnership is signed.
While Allon continues partnership negotiations in AD, it will move forward with a Phase II clinical trial in frontotemporal dementia (FTD). FTD describes several cognitive disorders, such as Pick’s disease, for which no treatment is currently available, including several that are fatal within three to five years of diagnosis. In addition, about 50% of the FTD disorders are tauopathies, or tau-related diseases. Allon’s technology is recognized as the most clinically advanced tau-related therapy.
The Company believes that there are regulatory routes to achieve an approval with FTD in a much shorter timeframe than AD, while moving forward concurrently with a partner in AD.
Dr. Bruce Miller, Professor of Neurology and Director of the University of California San Francisco Memory and Aging Center, said that over the past 10 years FTD has emerged as the most common cause of early-onset dementia under the age of 60 years, outstripping even AD in prevalence.
“Our review of AL-108 data related to impact on tauopathies has convinced us that this drug’s potential in FTD warrants investigation at the earliest opportunity,” Dr. Miller said.
In addition, the Company will initiate a Phase II study to examine the effect of AL-108 on human brain metabolism, which declines with progression of AD. Positron emission tomography (PET scans) will be used to image glucose metabolism in the brains of patients with AD, providing a method for evaluating the short-term treatment effects of AL-108. Examination of AL-108’s effects on human brain metabolism will add significantly to the understanding of dosing, pharmacokinetics and pharmacodynamics of AL-108.
The Company expects to announce top-line results in the first half of 2009 from a Phase II clinical trial evaluating the efficacy and safety of AL-108 in patients with schizophrenia-related cognitive impairment. Patient enrolment was completed in November 2008. This trial is being managed and funded largely by TURNS (Treatment Units for Research on Neurocognition and Schizophrenia) with support from the U.S. National Institute of Mental Health.
Beyond these specific clinical milestones, the Company will not advance further programs until the financial climate has improved.
“Our team has done an excellent job of pursuing our key milestones, while managing our cash prudently, which is why we will have cash into 2011,” McCauley said. “In this climate, the only added value recognized by the marketplace is human clinical progress. Therefore, we will continue to advance our clinical-stage assets, reduce non-essential costs, and examine ways to broaden our pipeline without impacting our clinical milestones or cash.”
Milestone Summary
• Execute a partnership agreement with a major pharmaceutical company.
• Commence a Phase IIb study in AD with a partner.
• Initiate a Phase II study in frontotemporal dementia.
• Initiate a Phase II PET study in AD patients.
• Announce top-line results from the Phase II study in schizophrenia-related cognitive impairment.
About FTD
Frontotemporal dementia (FTD) is a collection of neurodegenerative syndromes characterized clinically by behavioural disturbance, impaired fluency of speech, difficulty in finding words and involuntary movements in some cases. In contrast to AD, FTD generally affects younger patients aged 45-65 years.
FTD is a devastating disease with a median survival of approximately six years from symptom onset and three years after diagnosis in some types. The median time from symptom onset to institutionalization is approximately five years but only one year from formal diagnosis. According to Orphanet, the European portal for rare diseases and orphan drugs, the prevalence for FTD is approximately 3.6-15 per 100,000. Age at onset for FTD is generally earlier than AD and it is referred to as a pre-senile disorder.
FTD is most closely associated with atrophy of the brain involving the frontal lobes, temporal lobes or both, often asymmetrically. Neurochemical evaluations have demonstrated that the cholinergic system is largely intact while dopaminergic and serotoninergic systems are compromised. A variety of neuropathologic changes can be seen including neuronal loss, astrogliosis and loss of synapses but there is no single signature of changes.
Tau abnormalities are seen in several variants of FTD and make up approximately 50% of the FTD population. Neurofibrillary tangles that stain positive for tau are particularly associated with coritcobasal degeneration and progressive supranuclear palsy.
