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Beginning with non-opioid painkillers, we are leveraging our hydrogen sulfide platform to build a pipeline of anti-inflammatory drugs
As the global opioid crisis drives prescribers, patients, payors and policymakers toward non-addictive alternatives, nonsteroidal anti-inflammatory drugs ("NSAIDs") are increasingly used to treat acute pain. However, today's NSAIDs can cause gastrointestinal ("GI") ulcers and bleeding, especially at the higher doses often employed in acute indications.
Positioned as the NSAID-of-choice for post-operative pain, our lead drug, otenaproxesul, has demonstrated profound GI safety and robust efficacy in chronic pain in Phase IIB trials. In targeting the $13 billion1 post-operative pain opportunity, Antibe is aiming for a significant foothold in the overall $25+ billion2 acute pain market, including migraine, dysmenorrhea, traumatic injury, dental pain and gout.
Further leveraging our platform, the next planned addition to our pipeline targets inflammatory bowel disease, a $16 billion3 market long in need of safer, more effective treatments.
Anti-Inflammatory Drug Platform
Antibe’s platform targets inflammation by harnessing the unique properties of hydrogen sulfide to improve the safety and potency of existing anti-inflammatory medicines. More than 20 years of academic and commercial research have uncovered hydrogen sulfide’s key role in a wide range of biological functions. These include the promotion of anti-oxidant responses, activation of anti-inflammatory genes and the unique ability to substitute for oxygen to create cellular energy, underscoring its crucial role throughout human biology.4,5,6
Otenaproxesul: Lead Drug Targets an Urgent Medical Need
As the healthcare system responds to the opioid crisis, the $13 billion market for post-operative pain therapeutics is evolving. NSAIDs, as the main alternative to opioids, are being used more widely and have been shown to be equally effective in some acute pain settings.7,8 However, NSAIDs also triple the risk of serious gastrointestinal (“GI”) outcomes in 14-day course of treatment.9 Antibe scientists have published Phase IIB data in the British Journal of Pharmacology indicating that naproxen, a widely used NSAID, is sixteen times more likely to cause GI ulcers in a 14-day treatment period vs. otenaproxesul.10
Gastric Ulceration Rate 10
In addition to its remarkable GI safety, otenaproxesul has also demonstrated robust efficacy vs. placebo in a Phase IIB chronic pain trial at a high degree of statistical significance. Antibe’s extensive preclinical and clinical data suggest that the drug’s potency in chronic pain can address acute pain indications. In early 2022, Antibe initiated pharmacokinetic/pharmacodynamic (“PK/PD”) clinical studies to identify the optimal post-operative treatment regimen, setting the stage for a six-month Phase II program involving a single clinical trial, slated to begin later in the year.
Antibe is also investigating alternative dosing regimens as a potential path forward for chronic indications.
Intellectual Property
Composition-of-matter patents have been granted in major markets, including the US, Europe and Japan. Our NSAID program has successfully undergone extensive IP due diligence in these markets, with respect to both validity and freedom-to-operate. In addition, Antibe is assembling and filing patent applications aimed
at extending IP protection for our current pipeline into the 2040s.
Emerging Discovery Program
In addition to fortifying the IP position of our current pipeline drugs, Antibe’s research and development pursues select opportunities in next-generation anti-inflammatory medicines. The next drug planned for our pipeline targets inflammatory bowel disease (“IBD”). Afflicting more than three million American adults11, IBD is a condition long in need of safer, more effective therapies.
Commercialization
Otenaproxesul has been licensed in 58 countries to four licensees. These markets include Canada, China, Israel, Russia and South Korea. The most recent is an exclusive license with Nuance Pharma for the Greater China region, representing approximately 10% of the global pharmaceutical market.
Second pipeline drug: ATB-352
Our second pipeline drug, ATB-352, targets the need for a non-addictive analgesic for a specialized pain indication.
ATB-352 causes negligible GI damage in rats compared to ketoprofen, a strong NSAID used for a range of pain indications.
Inflammatory Bowel Disease PROGRAM
Targeting the need for a safer and more effective therapeutic for mild-to-moderate inflammatory bowel disease (“IBD”), the next drug planned for Antibe’s pipeline aims to help patients and prescribers delay the use of expensive, adverse effect-prone immunomodulators, steroids and biologics. Selected molecules are undergoing screening to identify a lead candidate for Investigational New Drug (“IND”)-enabling studies.
Leveraging Breakthrough Science
Antibe’s drug platform reflects more than two decades of research by our founder and Chief Scientific Officer, Dr. John L. Wallace, along with his colleagues in academic and commercial labs around the world. The research program is overseen by Scientific and Clinical Advisory Boards, comprising fifteen internationally renowned scientists and clinicians, with specialties in pharmacology, gastroenterology and a range of inflammatory diseases. Antibe strives for the most rigorous level of scientific validation—clinical studies and trials for otenaproxesul have involved more than 800 subjects to date, including 384 patients in its Phase IIB dose ranging, efficacy trial.
Our Vision
Expanding beyond pain and inflammation to include gastrointestinal and aging-related conditions—pursuing our vision for improving the health and quality of life of billions of people.
Our Management Team
Antibe’s senior team is based in Toronto, Canada. We are supported by a global network of advisors and subject-matter experts covering scientific, medical, clinical and regulatory affairs, and business development.
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1. Transparency Market Research (2019), 2021 projection.
2. Allied Market Research, Biotech Advisors, DataBridge, DelveInsight, GlobalData, Statista, Transparency Market Research, Antibe internal estimates.
3. GlobalData (2020).
4. Wallace JL and Wang R, Nature Rev Drug Discov. (2015) 14:329.
5. Zaorska E et al., Biomolecules (2020), 10, 323.
6. Olsen KR and Straub KD, (2016) Physiology 31: 60–72.
7. Lindbeck G, Prehosp Emerg Care. (2021 Dec) 20:1-17.
8. Choi et al., CMAJ 193 (24) (June 2021) E895-E905.
9. Fine M, Am J ManagCare. (2013);19(16 suppl):S267-S272.
10. Wallace JL et al., Br J Pharmacol (2019); 1-9.
11. U.S. Centers for Disease Control (2015).