Toronto, Canada-based Antibe Therapeutics is running a Phase IIb clinical trial of ATB-346, a hydrogen sulfide-releasing derivative of naproxen, to generate more efficacy and metabolism data.
Antibe designed ATB-346 to deliver the positive effects on pain and inflammation that make naproxen a widely used joint disease therapy, without also causing ulcers and other gastrointestinal problems associated with the nonsteroidal anti-inflammatory drug (NSAID).
The anticipated Phase IIb results are intended for two audiences, namely regulators and potential partners. Antibe had the same audiences in mind when it made a recent decision to engage a “leading global contract manufacturing organization” (CMO) to produce ATB-346.
In disclosing the CMO agreement, Antibe said, “This contract supports the interests of Antibe and its potential global partners by securing a reliable supply of ATB-346 to meet regulatory approval timelines.”
Antibe has long planned to develop ATB-346 up to the end of Phase II, describing the completion of mid-phase development as “a possible strategic exit point.”
Slower than expected enrollment in the Phase IIb has pushed that possible exit point back a little, with top-line data now due in the first quarter of 2020, but other pieces of the package it will offer to partners are in place.
The CMO means that, in theory, the manufacturing resources needed to take ATB-346 through Phase III and beyond are in place. While setting up the CMO agreement, Antibe has also worked to articulate the business opportunity it thinks will await the company that acquires the rights to take ATB-346 to market.
Specifically, Antibe has completed a global health economic study designed to show how much NSAIDs cost the US and has run a commercial positioning study. According to Antibe’s study, the direct costs of NSAIDs, including spending on the treatment of adverse events, amounts to $74bn a year.
Having completed the commercial positioning study, Antibe has tasked a life science consultancy with assessing the market opportunity and payer environment for ATB-346 in the US and Europe.
Antibe retains rights to ATB-346 in those key markets but has already entered into deals covering other countries. Kwangdong Pharmaceutical now holds the license in South Korea, while Acbel has rights to the drug in parts of Eastern Europe and North Africa.