Antibe Therapeutics Inc (ATBPF)

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NEWS IS OUT!!


Antibe completes ATB-346 validation studies

2015-12-21 08:42 ET - News Release

Mr. Dan Legault reports
ANTIBE THERAPEUTICS ANNOUNCES COMPLETION OF VALIDATION STUDIES OF ATB-346, PROGRESSION TO PHASE 2 CLINICAL TRIALS
Antibe Therapeutics Inc. has completed the previously announced validation studies being performed on the company's lead drug, ATB-346. These studies were initiated as a consequence of ATB-346 inducing an elevation of liver enzymes in some subjects taking the higher doses of the drug (750 and 1500 mg/day), and were aimed at gaining a better understanding of the drug's potency, absorption, metabolism and excretion characteristics. The results of these studies support progression to Phase 2 of development of this drug in patients with osteoarthritis.

In the first set of studies, as previously announced, the suppression of the activity of the cyclo-oxygenase (COX) enzyme, which accounts for the anti-inflammatory and pain-killing effects of ATB-346 (and all other NSAIDs), was substantially greater and longer lasting than had been predicted from the monitoring of blood naproxen levels. NSAIDs are well known to cause liver damage in some patients when taken at high doses.

In the second set of studies, rats were administered ATB-346, in which the hydrogen sulfide-releasing portion of the molecule was 'tagged' with a radioactive marker, thereby allowing it to be tracked after it was administered to each rat. This enabled monitoring of the excretion of ATB-346 and of its metabolites, and any accumulation of the drug in particular organs (such as the liver). There was no significant retention or accumulation of the radiolabel in any tissues, with more than 99% being excreted in urine. In rats treated daily with ATB-346 for four days, less than one-tenth of 1% of the radiolabel remained in the liver 8 hours after the final administration of the drug. Additionally, levels of retention of the radiolabel in other organs, including the kidney, stomach, small intestine and lungs, were extremely low. These studies also identified a number of metabolites of ATB-346, all of which were rapidly cleared.

The results of these studies warrant the continuation of development of ATB-346. They suggest that ATB-346 may be effective at lower doses than previously expected -- doses that were observed to be safe and well tolerated in the Phase 1 study. The studies also suggest that ATB-346 will produce beneficial effects with only once-daily dosing. Accordingly, Antibe plans to move forward with Phase 2 studies and will submit an application to Health Canada in early 2016.
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