Antibe Therapeutics finalizes report on ATB-346 studies2015-08-10 07:11 ET - News Release
Mr. Dan Legault reports
ANTIBE ANNOUNCES COMPLETION OF PHASE I STUDIES OF ATB-346 AND AN UPDATE ON ITS VALIDATION STUDIES
Antibe Therapeutics Inc.'s report on its phase 1 studies of ATB-346, its lead drug, has been finalized. This milestone permits Antibe to proceed, when appropriate, with filing of applications to appropriate regulators for phase 2 studies of ATB-346.
In phase 1, ATB-346 was found to be safe and well tolerated at a daily dose of 250 milligrams for 14 days. At this dose, and doses as low as 75 milligrams daily, ATB-346 markedly inhibited the enzyme cyclooxygenase, which is the target of non-steroidal anti-inflammatory drugs -- the degree of inhibition of COX activity correlates well with reduction of pain and inflammation. The inhibition of COX by ATB-346 persisted for 24 hours after administration, suggesting a once-daily dosing regimen for this drug of 250 milligrams or less.
As recently announced, Antibe's continuing validation studies of ATB-346 are progressing on schedule. These studies are aimed at gaining a better understanding of the absorption, excretion and key metabolites of ATB-346 after oral administration. The studies are being performed by Covance Laboratories in the United States using laboratory rats. The rats were treated with ATB-346 to which a radioactive label had been applied. This allows for tracking of the non-naproxen portion of the drug. The single-dosing portion of the study has been completed; data collected thus far demonstrate that over 93 per cent of the non-naproxen portion of ATB-346 was cleared from the body within 24 hours of oral administration. A multiple-dosing study is in progress. Antibe will continue to keep the market informed of progress in the continuing validation studies, the results of which remain on schedule for the fourth quarter.
We seek Safe Harbor.