Antibe Therapeutics Releases Secondary Endpoint Data from Recent Phase 2B Gastrointestinal Safety Study for Lead Drug, ATB-346
Published: Jul 03, 2018
Antibe announced the successful completion of this study on March 20, 2018 with strong primary endpoint data. The primary endpoint for the study was the incidence of gastric or duodenal ulcers of at least 3 mm diameter with unequivocal depth, considered the gold standard in assessing the GI safety of NSAIDs. As previously reported, subjects on ATB-346 exhibited an ulceration rate of 2.5% versus an ulceration rate of 42.1% for subjects on naproxen at the end of the 2-week treatment period. These results exhibited a very high degree of statistical significance (p<0.0001). ATB-346 was also safe and well tolerated.
Secondary Endpoint Data
The secondary endpoints in the study were:
- Incidence of gastric or duodenal ulcers of at least 5 mm diameter with unequivocal depth
- Number of gastric and/or duodenal erosions and/or ulcers
- Incidence of dyspepsia leading to discontinuation of study treatment
- Changes from baseline in hematocrit levels
- Changes from baseline in ex vivo whole blood thromboxane B2 (TXB2) synthesis
Incidence of gastric or duodenal ulcers of at least 5 mm diameter with unequivocal depth
No subjects treated with ATB-346 exhibited ulcers of more than 5 mm diameter (0% ulcer incidence) versus 30 subjects treated with naproxen (24% ulcer incidence), with an average of 2.5 ulcers per subject.
Number of gastric and/or duodenal erosions and/or ulcers
There were a total of 4 gastric ulcers and 0 duodenal ulcers in the ATB-346 group, versus a total of 203 gastric and duodenal ulcers in the naproxen group.
The average number of gastric and duodenal erosions (which are much less significant than ulcers) in the ATB-346 group was 1.7 per subject, versus 12.7 per subject in the naproxen group.
Incidence of dyspepsia leading to discontinuation of study treatment
There were no cases of dyspepsia (i.e., indigestion) leading to study discontinuation in either treatment group.
Change from baseline in hematocrit levels
There was no difference in change from baseline in hematocrit between the two treatment arms at the end of the two-week dosing period. A significant decrease in hematocrit is a potential indicator of intestinal bleeding.
Changes from baseline in whole blood thromboxane B2 (TXB2) synthesis
NSAIDs exert analgesic and anti-inflammatory effects through inhibition of cyclo-oxygenase (COX) enzyme activity. COX activity can be assessed by measuring a biomarker in the blood known as TXB2.
The average baseline TXB2 values were 86 ng/mL in the ATB-346 treatment group versus 88 ng/mL in the naproxen group (no significant difference). Both naproxen and ATB-346 inhibited TXB2 synthesis by more than 94%.
John Wallace, Antibe’s Chief Scientific Officer, remarked, “The secondary GI safety endpoint data for ATB-346 are consistent with the primary endpoint data, showing unequivocal superiority over naproxen. Moreover, the thromboxane data demonstrate that profound COX inhibition was achieved with ATB-346 at 250 mg once daily, fully consistent with the Phase 2A study completed in 2016 that showed excellent pain relief compared with published data for naproxen and celecoxib. We look to fully validate the effectiveness of ATB-346 in our upcoming Phase 2 dose-ranging, efficacy study.”
A comprehensive review of the study will be posted on the Company’s website in the coming weeks.
ATB-346 is a hydrogen sulfide-releasing derivative of naproxen. NSAIDs are the most commonly used therapy for osteoarthritis, yet their use is associated with a high incidence of gastrointestinal ulceration and bleeding. NSAIDs are also widely used in conditions such as rheumatoid arthritis, ankylosing spondylitis, gout, and general pain reduction, with a similarly high rate of gastrointestinal ulceration and bleeding. It is well-accepted that patients with these conditions would benefit greatly from an effective, non-addictive, GI-sparing anti-inflammatory/analgesic agent such as ATB-346.
About Antibe Therapeutics Inc.
Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer, non-addictive drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com.
Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com.
Forward Looking Information
This news release includes certain forward-looking statements, which may include, but are not limited to, the proposed licensing and development of drugs and medical devices. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "will", "anticipate", "believe", "plan", "estimate", "expect", "intend", "propose" and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company’s inability to secure additional financing and licensing arrangements on reasonable terms, or at all, its inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. Antibe Therapeutics Inc. assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
Antibe Therapeutics Inc.
Dan Legault, 416-473-4095
Chief Executive Officer
Source: Antibe Therapeutics Inc.