The US marks World Arthritis Day this Monday as 23% of its population — over 54 million Americans — cope with the debilitating condition. More than one in four Americans with arthritis suffer acute joint pain, according to the US health protection agency the CDC.
Yet, there has been remarkably little innovation in the treatment of arthritis pain in 50 years.
People with osteoarthritis, the most prevalent form of arthritis with symptoms like pain, stiffness and decreased range of motion, often take over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen. But these painkillers can cause serious gastrointestinal side effects, and kidney damage.
Pain relief without stomach damage
The company aims to shake up the $16 billion NSAID market with a revolutionary new drug that could match the effectiveness of today’s NSAIDs — without the ulcers and bleeding that have often accompanied their use since aspirin was introduced by Bayer (OTCMKTS:BAYRY) in 1899.
The American Council on Science and Health (ACSH) has said Antibe’s lead drug otenaproxesul, formerly known as ATB-346, could be a potentially “much safer and possibly more effective option” for the treatment of chronic pain and inflammation than anything currently on the market.
"Today's NSAIDs are effective for osteoarthritis, but they can cause ulcers and bleeding in many patients. We've designed otenaproxesul to address these problems,” Dr Joseph Stauffer, who is chief medical officer at Antibe, told Proactive.
“It has already shown impressive gastrointestinal safety and efficacy in human studies, and we are looking to confirm these characteristics in our upcoming Phase III trials," he added.
Following his medical training, Dr Stauffer practiced frontline medicine for a decade, including eight years as a US Navy physician. He then joined the US Food and Drug Administration (FDA) as a medical review officer for anti-inflammatory and analgesic drugs, subsequently being recruited by Abbott Laboratories (NYSE:ABT) as global medical director.
“In addition to my role as a doctor, arthritis is a personal journey for me – I damaged my knee playing sports as a teenager and that knee is now developing arthritis, the other knee is fine. That’s the uncontrollable part,” said Dr Stauffer.
“When I was a US Navy doctor and later a private practice physician, I saw many arthritis patients, mostly with osteoarthritis, which largely affects older people. I saw it in military veterans and their spouses, as well as elderly patients in private practice. It is a truly debilitating condition for many people.”
Upcoming Phase III program
In August, Antibe revealed that it plans to file an Investigational New Drug (IND) application with the US Food & Drug Administration (FDA) for otenaproxesul in the coming months to allow for Phase III clinical trials in the US. If the drug is approved, it could achieve peak sales of US$3.9 billion in the major markets, according to third-party commercial projections.
In the successful Phase IIB trial results released in June this year, otenaproxesul showed clear superiority to a placebo in pain reduction and other key measures. According to the company, it also showed “unequivocal superiority” to naproxen in gastrointestinal safety in an earlier Phase IIB clinical trial.
Channeling hydrogen sulfide
Otenaproxesul is a novel drug that releases hydrogen sulfide and clearly the chemical wasn't incorporated as an accident.
“The hydrogen sulfide isn't just coming along for the ride; it can also act as an anti-inflammatory agent,” said a report by Josh Bloom in the American Council on Science and Health’s publication. “Endogenous gaseous mediators are involved in multiple cellular processes, including cell repair, inflammation, and smooth muscle tone.”
Antibe was founded by scientist Dr John Wallace who studied hydrogen sulfide as an anti-inflammatory and has focused on developing new medicines based on those findings.
“John Wallace’s insight into hydrogen sulfide’s anti-inflammatory potential is destined to change how we treat pain,” said Nobel Laureate, Dr Louis Ignarro, who co-chairs Antibe’s Scientific Advisory Board.
The top American pharmacologist won the Nobel for his work in demonstrating the signalling properties of nitric oxide, prefiguring Dr Wallace’s discovery of hydrogen sulfide’s crucial role in mediating inflammation.
Spearheaded by Dan Legault, Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation, safer non-addictive drugs for pain and inflammation arising from a wide range of medical conditions. The company, which recently strengthened its balance sheet with a $29 million bought deal, is also developing a safer alternative to opioids for peri-operative pain, and a gastrointestinal-safe alternative to low-dose aspirin.
Osteoarthritis drugs are receiving increased industry attention since last week’s $530 million in-licensing of an early-stage drug by Novartis (NYSE:NVS). Antibe already has three regional licenses in place and is stepping up partnering activities following its recent clinical trial success.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive