Ann Arbor-based Adeona Pharmaceuticals Inc. (AMEX: AEN) late Thursday reported top-line results from its clinical study evaluating reaZin for the dietary management of Alzheimer’s disease and mild cognitive impairment.
The clinical study met the primary outcome of increasing serum zinc and decreasing serum free copper. In addition, secondary outcomes of mental status as measured by three standardized cognitive tests all favored the treatment group versus the placebo group.
The clinical study data was presented at the Annual Meeting of the American Academy of Neurology in Honolulu, Hawaii by Diana Pollock, M.D., Lead Principal Investigator of the study at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital.
The poster titled “Clinical Trial Results of the First Controlled Clinical Trial of Zinc-Based Therapy for Alzheimer’s Disease and Mild Cognitive Impairment” included findings from 42 of 57 subjects evaluable at the end of the study.
The results are as follows:
* The treatment group showed significant reductions in serum free copper levels and elevations in serum zinc levels over the placebo group, resulting in a highly statistically significant change in the free copper to zinc ratio (-20.8%), the primary outcome of the clinical study (p < 0.0006).
* An average net decrease in serum free copper of -6.5 microg/dL for the treatment group versus placebo group.
* An average net increase in serum zinc of 64.6 microg/dL for the treatment group versus the placebo group.
Comparisons of the average changes in cognitive scores at baseline and 6 months are presented below. Although the individual p-values of the cognitive scores did not achieve statistical significance (p < 0.05), all three of these cognitive measures favored the treatment group versus the placebo group.
Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog), an average net improvement of 0.41 points in favor of the treatment group versus placebo (p < 0.36)
Clinical Dementia Rating Scale – Sum of Boxes (CDR-SOB), an average net improvement of 0.38 points in favor of the treatment group versus placebo (p < 0.10)
Mini Mental State Examination (MMSE), an average net improvement of 0.19 points in favor of the treatment group versus placebo (p < 0.42)
The Estimated Generalized Least Square method was used to calculate a composite cognition score combining each of the secondary cognitive measures (ADAS-Cog, CDR-SOB and MMSE) at baseline and 6 months. The composite cognitive score approached statistical significance, indicating a strong trend toward cognitive benefit favoring the treatment group (p < 0.15).
Results reported from Part 2 of this clinical study demonstrated that re aZin was safe and well tolerated by subjects in the treatment group and dropouts were equivalent across the treatment and placebo groups. These results confirm the previously reported results from Part 1 of the clinical study (April 14, 2010) that demonstrated reaZin was well tolerated and superior to Galzin®, an FDA-approved zinc preparation.
A copy of the poster presented at the AAN meeting is available at www.adeonapharma.com/AANposter.pdf.
“We are highly encouraged by the results from this clinical study, especially achieving the primary outcome with the statistically significant change in the free copper to zinc ratio in the treatment group over the placebo group,” stated George J. Brewer, M.D., Adeona’s senior vice president of research & development. “Also, of ultimate importance with respect to a potential treatment for Alzheimer’s disease patients, the composite score supports cognitive benefit in the treatment group versus the placebo group.”
Pollock also commented on the clinical study: “In my clinical experience, this zinc therapy appears to have been extremely well tolerated and may represent a new mechanism of action to address the cognitive deficits in Alzheimer’s patients. This potential treatment deserves further study in larger clinical trials.”
“Based on the favorable results presented from this clinical study, we intend to further the commercial development of reaZin as a prescription medical food for the dietary management of Alzheimer’s disease and mild cognitive impairment,” said James S. Kuo M.D., Adeona’s Chief Executive Officer. “In addition, we will be reviewing the results from our clinical study with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims.”
To listen to a replay of a conference call discussing the results, visit www.adeonapharma.com.
Two scientific observations support Adeona’s hypothesis that correcting zinc and free copper abnormalities could benefit AD patients as measured by cognitive scores.
The prospective, randomized, double-blind, placebo-controlled clinical study represents the first controlled clinical study evaluating the safety and efficacy of a zinc and cysteine-based therapy (reaZin) for Alzheimer’s disease. Study subjects were randomized into the active treatment group or the placebo group and were assessed at baseline, 3 months and 6 months. Primary outcome measures include serum zinc and serum free copper. Secondary outcomes include cognitive measures using ADAS-Cog, CDR-SOB and MMSE.
ReaZin, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties. reaZin was developed by Adeona to achieve the following: 1) the convenience of a once-daily dose, 2) high bioavailability (the quantity or fraction of the ingested dose that is absorbed by the body) and 3) the ability to minimize gastrointestinal side effects of oral zinc therapy.
More at www.adeonapharma.com.