Investors are gobbling up shares of Antibe Therapeutics (TSX-V: ATE)(OTCQB: ATBPF) following the Toronto-based drugmaker saying that its flagship drug, ATB-346, hit the primary endpoint of safety versus naproxen in a mid-stage gastrointestinal trial in healthy patients. Naproxen, which is sold under the brand names Aleve and Naprosyn, amongst others, is the top-selling nonsteroidal anti-inflammatory drug (NSAID) in the United States.
NSAIDs, a class of drugs that also includes other common-used members like ibuprofen (brand name Motrin) and indomethacin (brand name Indocin), are notorious for being helpful in alleviating pain and swelling with more than a handful of potentially serious side effects. NSAIDs are frequently prescribed for osteoarthritis, rheumatoid arthritis and general pain reduction, as the benefits are believed to offset the high rate of gastrointestinal ulceration and bleeding.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. The company believes the experimental drug has the potential to deliver the same therapeutic response as its marketed peers, while sparing the GI tract.
In the double-blind phase, 244-patient 2b study, ATB-346 demonstrated superiority over naproxen with an ulceration rate of only 2.5 percent in the ATB-346 group compared to 42.1 percent for subjects on naproxen after two weeks of therapy.
Subjects received either 250 milligrams of ATB-346 once daily (a level shown in prior research to have a meaningful response in relieving osteoarthritic pain) or 500 milligrams of naproxen twice a day.
Only three out of 118 patients on ATB-346 developed ulcers of a pre-defined scope, compared to 53 out of 126 patients on naproxen therapy.
"Gastrointestinal safety has been a major global concern with NSAIDs for decades and we now have clinical data unequivocally demonstrating a solution to this unmet and serious medical problem," said Antibe’s Chief Scientific Officer, John Wallace, in today’s news release.
Antibe plans to conduct a placebo-controlled, dose-escalation trial of ATB-346 for pain during the fourth quarter as it continues to negotiate possible licensing deals for the drug.
As recently as October, shares of ATE could have been picked up for eight cents each. As research continues, an uptrend developed, including hitting a high of 44 cents last week. With today’s news, shares have sprinted ahead another 75.0% to trade at 63 cents about 1-1/2 hours into the session after printing an intraday high at 79 cents only minutes after the opening bell.
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