Antibe Therapeutics Inc (CVE:ATE) (OTCMKTS:ATBPF) has just eliminated one giant hurdle for investors. Free from the always-looming shackles of potentially damning safety results, the response has been euphoric.
Today, the company announced that its lead drug, ATB-346, met its primary endpoint in the Phase 2B gastrointestinal (GI) safety study. In reality, the company was just being modest. Antibe Therapeutics absolutely obliterated its primary endpoint, with subjects taking ATB-346 exhibiting an ulceration rate of 2.5% versus an ulceration rate of 42.1% for subjects on naproxen at the end of the 2-week treatment period. In case you were wondering, naproxen is the most prescribed nonsteroidal anti-inflammatory drug in North America.
Details of the study further highlight the impressive trial results. For starters,the endpoint was achieved with subjects received only receiving one daily dose of ATB-346 (250 mg) versus two daily doses of naproxen (500 mg). As most studies will attest, less required doses generally equal higher patient intake rates. If ATB-346 can provide the same therapeutic benefits as naproxen with longer in-between medication times, that in itself provides a significant advantage.
The primary endpoint for the study itself was the incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth. This is considered the gold standard in assessing the GI safety of non-steroidal anti-inflammatory drugs (NSAIDs). The aggregate raw data was every bit as impressive as the percentages above indicate. Remarked Antibe’s Chief Scientific Officer, John Wallace, “The number of subjects that developed ulcers while on treatment with ATB-346 was 3 (out of 118), compared to 53 (out of 126) for subjects treated with naproxen.” This result was achieved with what Wallace describes as “This an impressive level of statistical significance”.
With ATB-346 GI safety concerns put to rest, the company can now go about raising capital and partnering with global pharmaceutical firms to further develop the compound.
Next up for Antibe Therapeutics: A placebo-controlled dose ranging and effectiveness study with a data read-out expected in Q4 2018. The company also plans on accelerating development of their other novel NSAIDs, including ATB-352, a non-addictive analgesic for the treatment of severe pain that addresses the global opioid crisis.
Worldwide, the market is worth around $80 billion annually.
Board Of Directors Addition
Signaling that Antibe Therapeutics is serious about partnering up, the company announced the appointment of Amal Khouri (B.Sc., MBA) to its Board of Directors, effective immediately. Of course, Mr. Khouri has all the necessary credentials one might expect from a director. But the likely driver of the move is Mr. Khouri’s extensive contacts within the pharmaceutical industry. The press release states as much:
Ms. Khouri has extensive experience in global partnering and licensing deals in the pharmaceutical industry. Her expertise will be a tremendous asset to our Board and shareholders as we prepare to commence global partnering discussions for our lead drug, ATB-346.
Given the wonderful news brought forth today, chances are Antibe Therapeutics will likely be successful in that quest.
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