VANCOUVER, B.C. — Allon Therapeutics Inc. (TSX: NPC) today announced that clinical trial results confirming the positive pharmacokinetic characteristics of the Company’s lead neuroprotective drug candidate, davunetide, will be presented at the American Society for Clinical Pharmacology and Therapeutics annual meeting in Dallas, Texas on Friday, March 4. The data demonstrate that intranasal administration of davunetide yields the pharmacokinetic characteristics and brain concentrations apparently necessary to show clinical efficacy.
Bruce Morimoto, Allon’s Vice President of Drug Development, said the pharmacokinetic data are supportive of the Company’s ongoing pivotal Phase 2/3 clinical trial in patients with progressive supranuclear palsy (PSP), a rapidly-progressing and fatal degenerative brain disease.
“These data demonstrate that administration of davunetide to healthy individuals and to Alzheimer’s disease patients is available in the circulation, taken up into the brain and detectable in the cerebrospinal fluid (CSF) in sufficient concentrations predicted to show efficacy,” said Morimoto.
“The non-compartmental pharmacokinetic model of davunetide in plasma and CSF is pertinent to dose selection for our pivotal Phase 2/3 pivotal trial in PSP patients, and relevant to our second generation davunetide product program targeting Alzheimer’s, Parkinson’s disease, schizophrenia and other dementias,” said Morimoto.
The American Society for Clinical Pharmacology and Therapeutics is the largest scientific and professional organization serving the discipline of clinical pharmacology. The annual meeting is attended by more than 1,000 scientists, pharmacists, physicians, research coordinators, students and trainees.
About davunetide
Allon is currently enrolling patients in a pivotal Phase 2/3 clinical trial evaluating davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly-progressing and fatal movement disorder with dementia which is often misdiagnosed as Parkinson’s or Alzheimer’s disease. Allon reached agreement on a Special Protocol Assessment with the U.S. Food and Drug Administration, as well as Orphan Drug and Fast Track Status in the U.S. Similarly, Allon has Orphan Status for davunetide in the EU. Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon’s human clinical and pre-clinical data suggest that davunetide works on microtubules, structures in the brain critical to communication between cells, and central to the tau pathway. Davunetide has shown statistically significant impacts on memory, activities of daily living, and a biomarker of brain cell function and integrity. Allon has extensive intellectual property protecting davunetide.
About Allon’s neuroprotective platforms
Allon’s two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer’s disease, cognitive impairment associated with schizophrenia, and progressive supranuclear palsy (PSP). AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.
About Allon
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on developing the first drugs that impact the progression of neurodegenerative diseases. Allon’s lead drug davunetide, is proceeding in a Phase 2/3 clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under an SPA with the FDA. This pivotal trial is based upon statistically significant human efficacy demonstrated in amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
The Company is listed on the Toronto Stock Exchange under the trading symbol “NPC” (Neuro Protection Company™) and based in Vancouver. For additional information please visit the Company’s website: www.allontherapeutics.com.
Forward Looking Statements Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as “believes”, “may”, “plans”, “will”, “estimate”, “continue”, “anticipates”, “intends”, “expects”, and similar expressions. While forward-looking statements represent management’s outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon’s early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon’s dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon’s public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
FOR FURTHER INFORMATION PLEASE CONTACT:
Investor Contact Allon Therapeutics Inc. Aaron Keay Director, Investor Relations (604) 323-6911 Email: info@allontherapeutics.com Website: www.allontherapeutics.com
Media Contact Edie DeVine, GCI Health (415) 365-8543 Email: edie.devine@gcihealth.com
