Top-line Data Awaited in Phase 2b Trial of Alternative to Naproxen as Painkiller

Antibe Therapeutics has fully enrolled a trial comparing the gastrointestinal safety of investigative compound ATB-346 with naproxen, a nonsteroidal anti-inflammatory drug (NSAID). The Phase 2b trial is running as scheduled, and the company plans to release top-line data within six weeks.

Naproxen, sold under the brand names Aleve, Naprosyn, and others, is one of the most commonly prescribed NSAID painkillers in the United States. ATB-346, which is derived from naproxen, was developed to treat the pain associated with osteoarthritis and other diseases, including ankylosing spondylitis, which is commonly managed with NSAIDs.

NSAIDs are associated with high rates of gastrointestinal ulceration and bleeding. As such, patients who use the medication could benefit from an effective alternative that does not cause those problems.

The Phase 2B trial (NCT03291418) aims to show that ATB-346 leads to fewer GI side effects than naproxen. ATB-346 did not damage the GI tracts of rodents and dogs during pre-clinical studies, even at high doses. A total of 240 healthy volunteers were enrolled in the ongoing trial and randomized to receive 250 mg once daily of ATB-346, or 550 mg twice daily of naproxen, for 14 days.

Participants will undergo gastroduodenal endoscopies — nonsurgical procedures to examine the inner lining of the stomach and of the first portion of the small intestine — before and after treatment. Researchers will check if the volunteers develop ulcers or erosions with either of the treatments during the 14-day trial period.

“We are pleased to provide an update on the progress and timing of our on-going clinical study of ATB-346,” John Wallace, chief scientific officer of Antibe, said in a press release.  “The final subjects have commenced dosing and will be on treatment for two weeks, followed by a two-week monitoring period and then standard data analysis for the primary endpoint.”