Allon's AL-208 for cognitive impairment well-tolerated in phase 1 trial

By Lisa Kerner

Erie, Pa., Feb. 28 - Allon Therapeutics, Inc., The Neuro Protection Co., said its phase 1 human clinical trial demonstrated that the company's second product, AL-208, was safe and well-tolerated in 64 healthy elderly adults.

AL-208 is being developed as a treatment for the mild cognitive impairment that occurs in 90% of cases in the first week following coronary artery bypass graft (MCI post-CABG) surgery, according to a company news release. The market for MCI post-CABG is estimated at $500-million and there is currently no treatment available.

In the phase 1 trial, single doses of the drug were administered intravenously to groups of subjects at 10, 30, 50, 100, 200 and 300 milligrams. The trial was conducted in San Antonio by Healthcare Discoveries Inc., a division of Catalyst Pharma Group, Inc.

Allon said success of the phase 1 trial will result in two follow-up clinical trials for AL-208 later this year.

The first is a phase 2a trial to evaluate the effectiveness of a single dose of AL-208 in 200 patients with MCI post-CABG.

The second is a phase 1b trial to evaluate the drug's safety, tolerability and pharmacokinetics in chronic neurodegenerative conditions that require more than a single dose in healthy elderly adults and in patients with type 1 and type 2 diabetes.

"The upcoming phase 2a clinical trial of AL-208 is particularly significant for Allon because it will be our first efficacy trial for the several promising drug candidates emerging from our two drug platforms," Allon president and chief executive officer Gordon McCauley said in the release.

The company also plans to apply to Health Canada for permission to include patients in Canadian medical centers in the phase 2a trial.

Allon, a development-stage biotechnology company, develops drugs that protect against neurodegenerative conditions such as Alzheimer's, cognitive impairment, stroke, traumatic brain injury, multiple sclerosis and neuropathy. The company is located in Vancouver, B.C.

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