Antibe engages global CMO to support planned pain drug partnership

By Nick Taylor

- Last updated on GMT

(Image: Getty/Krittiraj Adchasai)
(Image: Getty/Krittiraj Adchasai)

Related tags: Antibe

Antibe tasks global CMO with providing a reliable supply of pain drug, ATB-346.

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.

Related news

Show more

Related products

show more

Laboratory Solutions for COVID-19 Clinical Trials

Laboratory Solutions for COVID-19 Clinical Trials

Q2 Solutions | 10-Jun-2020 | Clinical Study

As a leading laboratory services organization for trials across the globe, we are proud to partner with clients to support COVID-19 clinical trials. Our...

Parents as Gatekeepers for Children with Cancer

Parents as Gatekeepers for Children with Cancer

PRA Health Sciences | 08-Jun-2020 | Technical / White Paper

The RACE for Children Act will require new drugs intended for adult cancer treatment to also be studied in pediatric cancers when the molecular target...

RACE Act Prompts Pediatric Oncology Trials

RACE Act Prompts Pediatric Oncology Trials

PRA Health Sciences | 04-May-2020 | Technical / White Paper

Many providers prescribe drugs off-label to pediatric patients, even though there have been few pediatric trials for many of these drugs. In response,...

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Manufacturing Cyto and Non-Cyto Drugs in One Facility

Baxter BioPharma Solutions | 01-Mar-2020 | Technical / White Paper

Recent market reports suggest increasing product niches, which may lead to decreasing numbers of units per product, making dedicated facilities less practical....

Related suppliers

Follow us

Products

View more

Webinars