Antibe Therapeutics Inc (CVE:ATE) (OTCMKTS:ATBPF) Tuesday provided an update on the Phase 2B study of its flagship drug ATB-346 to treat acute and chronic pain associated with osteoarthritis.
“The clinical trial is proceeding well and the company is pleased with the execution and quality of patient screening, which determines admittance into the study across the 35 clinical sites,’’ Antibe said in a statement.
The clinical study commenced in March 2019 and is designed to validate the effectiveness of ATB-346 in reducing pain and establish the dose for Phase 3 development.
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ATB-346 is a hydrogen sulfide-releasing derivative of naproxen, the most prescribed nonsteroidal anti-inflammatory drug (NSAID) in the US.
A total of 360 patients with osteoarthritis of the knee are being randomized to either placebo or one of three doses of ATB-346 administered once daily -- 150 mg, 200 mg or 250 mg.
However, Antibe said previous guidance for enrollment of the last patient had been the third quarter of 2019, which will now occur in the fourth quarter.
The delay is largely the result of the rigorous screening discipline and a temporary slowdown in patient recruitment due to the summer holiday period, the Toronto-based company noted.
“We have designed our clinical trial in a rigorous way and have been successful to-date in recruiting suitable patients to ensure a robust set of data,” said CEO Dan Legault. “Although this has mildly delayed our timelines, we view data quality as paramount for this trial.”
Legault went on to add that “with the recent successful financing, we’re adequately capitalized to complete the trial while funding continued development of our other programs, and anticipate being in a strong position to negotiate potential partnerships upon a successful study outcome.”
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