FDA’s Recent Greenlight for Human Clinical Trials(3), Antibe Therapeutics Is Potentially Taking a Chunk of a $3.9 Billion Market(6)
No one should have to deal with arthritic pain.
At nearly 70, my dad deals with the excruciating pain of it. It’s not easy, nor is it comforting to watch him struggle just to move. I’ll try to help, but he tells me he’s got it.
I’m sure many of you can relate.
Unfortunately, there are millions more just like my dad.
According to the US Centers for Disease Control and Prevention (CDC), approximately 23% of adults in the US have arthritis. Sadly, roughly 24 million people have limited their activities thanks to it, with about 25% of people reporting severe joint pain.(4)
To treat it, millions turn to NSAIDs or non-steroidal anti-inflammatory dr-ugs. In fact, about 84 million NSAID prescriptions are written every year in the US, according to Fortune Business Insights.(5)
The problem, though, is NSAIDs aren’t always a great option. Unfortunately, they may actually make things worse.
They have adverse effects, like severe gastrointestinal (GI) ulcers and bleeding. The last thing you want on top of arthritic pain is a stomach injury.(6)
NSAID-induced GI damage is a globally recognized problem that has vexed doctors and patients for more than 50 years. Even treatment strategies intended to prevent side effects can lead to new complications.
For example, the co-prescription of proton-pump inhibitors for stomach protection can lead to intestinal damage. Also, with cele-cox-ib, co-prescription of aspirin for cardiovascular safety can nullify GI protection and lead to intestinal damage.(6)
That’s where a company like Antibe Therapeutics Canada TSX: (ATE) United States OTC: (ATBPF) may be able to help.
The company’s otenaproxesul is a hydrogen sulfide-releasing analog of naproxen, a widely used NSAID. Naproxen can cause significant gastrointestinal (GI) side effects. However, otenaproxesul, a next-generation NSAID, has demonstrated efficacy and minimal GI side effects in Phase IIB trials with osteoarthritis (OA) patients.(6)
That could be a game-changer for the company and millions of potential patients.
After finding double bottom support between roughly $3.38 and $3.47 a share, the ATE stock more than doubled to approximately $7.52 a share. While the stock has since pulled back and approached its 200-day moving average at roughly $4.30, we may be looking at some serious breakout potential. After all, the company might be nearly oversold with a 14-day RSI of approximately 35. Not to mention, it’s received US FDA clearance for its Investigational New Dr-ug application for otenaproxesul, which is in development to treat osteoarthritis pain.
The US FDA news now allows Antibe to start human clinical trials for otenaproxesul in the US. Also, the company anticipates initiating its Phase III program later this year.(7)
Better, its short-, medium-, and long-term indicators appear to be bullish, including its 20-day MA, 20-50 day MACD oscillator, 20-100 day MACD oscillator, 20-200 day MACD oscillator, 50-day MA, 50-100 day MACD oscillator, 50-200 day MACD oscillator, 100-day MA, 150-day MA, 200-day MA, and 100-200 day MACD oscillator.
Fundamentally, though, the company could be just as strong.
- Science: Human proof-of-concept firmly established for its lead dr-ug following Phase II trials.
- Third Party Validation: Four regional partnerships, including China, have been secured to date.
- Partnering Focus: The company has now shifted its focus to securing strategic partnerships in the large markets, mainly the US, Europe and Japan.
- Cash Position: The company has a strong cash balance, providing more than two years of runway.(14)
Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation caused by a range of medical conditions.
The company’s current pipeline includes three assets that seek to overcome the gastrointestinal ulcers and bleeding associated with NSAIDs.(13)
- Antibe’s lead medicine, otenaproxesul, is preparing to enter Phase III trials for the treatment of osteoarthritis pain.
- Additional assets under development include a safer alternative to opioids for perioperative pain and a GI-protective alternative to low-dose aspirin.
- The company’s next target is inflammatory bowel disease (IBD), a condition long in need of safer, more effective therapies.
Their lead dr-ug, otenaproxesul is a hydrogen sulfide-releasing analog of naproxen, a widely used NSAID. Unfortunately, naproxen can cause significant GI side effects. Despite these issues, naproxen is the #1 ranked non-invasive treatment for knee OA in a 2018 meta-analysis published in the Journal of the American Academy of Orthopaedic Surgeons.(15)
In contrast to naproxen, otenaproxesul has already shown dramatic GI safety in a Phase IIB trial with osteoarthritis (OA) patients; it also showed significant efficacy.(6)
Third-party studies have validated the commercial potential of the treatment. Plus, the company anticipates broadening the dr-ug’s indications to help treat rheumatoid arthritis, ankylosing spondylitis, and other acute and chronic pain conditions.(6)
Validation from Recent Partnering Deal for Greater China Region(10)
Antibe Therapeutics recently announced a licensing agreement with Nuance Pharma to commercialize otenaproxesul in the Greater China region. Nuance is a biopharmaceutical company focused on licensing, developing, and commercializing globally innovative therapies to address critical unmet medical needs in China and other Asia-Pacific markets.
Under the terms of the agreement, Antibe is entitled to US$100 million in milestone payments, including US$20 million upfront and US$80 million in development and sales milestones, in addition to a double-digit royalty on sales. Clinical development and regulatory costs for the region will be borne by Nuance. Antibe and Nuance have established a structure for collaborating on otenaproxesul’s clinical development in the region, ensuring a fit with Antibe’s global regulatory strategy.
China’s extensive economic progress, combined with significant advances in dr-ug regulation, intellectual property protection, and health insurance coverage, has stimulated demand for leading-edge therapies. This trend has been particularly evident in pain management, a market that has doubled in the past five years, driven principally by the demand for NSAIDs like otenaproxesul.
Antibe Therapeutics Canada TSX: (ATE) United States OTC: (ATBPF) ATB-352 Exposed to a Potential $11 Billion Market
At the moment, there are approximately 50 million surgical procedures in the US annually that require pain medication. About 80% of these patients are prescribed opioids.(6)
However, the opioid crisis means that doctors are seeking new ways of managing post-surgical pain.
This is where Antibe’s safer analgesic for peri-operative pain (addressing pain before, during and post-operatively) could potentially assist, enabling non-addictive but potentially effective pain relief.
The company is also working on ATB-340, a GI-safe alternative to aspirin, where academic proof of concept studies is underway.(6)
Upcoming Catalysts for Antibe Therapeutics …
Strong Leadership, Strong Results — Antibe Therapeutics Canada TSX: (ATE) United States OTC: (ATBPF)
Antibe’s senior team is supported by a global network of advisors and subject matter experts covering scientific, clinical and regulatory affairs, and business development.
Dan Legault, JD
Chief Executive Officer & Director
Trained as a corporate lawyer and as an air force rescue pilot, Dan’s career has evolved to focus on high-growth, mostly technology-based companies. His CEO-level experience includes organizations specializing in data analytics, IT and consumer marketing.
He has served on the boards of directors of International Save the Children and of a leading health benefits administrator. Dan continues to serve as a board member and advisor to several companies and not-for-profit organizations.
John L. Wallace, PhD, MBA
Founder, Chief Scientific Officer
Dr. Wallace is widely recognized as an expert in gastrointestinal inflammation and in the development of innovative anti-inflammatory medicines. In the mid-1990s, he co-founded NicOx and chaired its Scientific Advisory Board. (NicOx was the first company to achieve regulatory approval for dr-ugs using gasotransmitters.)
Dr. Wallace and his research colleagues are credited with identifying one of the main mechanisms of damage to the stomach by NSAIDs. More recently, he was the first to uncover hydrogen sulfide’s anti-inflammatory properties, leading to the formation of Antibe Therapeutics. He is Founding Director of the Farncombe Family Digestive Health Research Institute at McMaster University and former President of the Canadian Association of Gastroenterology.
Joseph Stauffer, DO, MBA, FAPCR
Chief Medical Officer
Following his medical training, Dr. Stauffer practiced frontline medicine for a decade, including eight years as a US Navy general practice physician. He then joined the US Food and Dr-ug Administration (FDA) as a Medical Review Officer for anti-inflammatory and analgesic dr-ugs, subsequently being recruited by Abbott Laboratories as Global Medical Director. Over the succeeding years, Dr. Stauffer led clinical operations, regulatory and medical affairs teams at Alpharma and Ikaria, each of which was acquired in $1.6 billion cash transactions. He was also instrumental in guiding the clinical development programs that underpinned equity raises totaling more than $250 million for Cara Therapeutics, a developer of novel chemical entities to treat post-operative pain and chronic itch in Chronic Kidney Disease.
David Vaughan, PhD
Chief Development Officer
As a scientist and dr-ug development executive, Dr. Vaughan has extensive experience in bringing dr-ugs from early investigation to regulatory approval. Acting as a product development consultant for several major pharmaceutical firms, he has advanced treatments for bacterial infections and disorders of the central nervous and gastrointestinal systems. Dr. Vaughan headed the Clinical Anti-infectives Unit for Bayer Inc. He also served as Vice President, Pharmaceutical Business Unit for Focus Technologies USA; Vice President, Preclinical Development for Affinium Pharmaceuticals; and Vice President, Preclinical Development for NeurAxon.
Alain Wilson, MBA
Chief Financial Officer
Alain is a seasoned CFO and consultant to private and public companies. He is a founding partner of Revelstoke Partners, a boutique consulting firm focused on assisting mid-market companies in challenging circumstances, such as extreme growth or a fundamental change in business model. He was founder and former Head of the Toronto Office of Mercer Management Consulting (now Oliver Wyman), where he was instrumental in growing the office to more than 50 people. Alain was also elected senior partner at Mercer worldwide.
Antibe has partnering muscle and a track record of deals …
Now they’re gearing up to negotiate additional regional and large market partnerships, with world-class advisors supporting their efforts, including the former CEO of Shire (which was acquired by Takeda for more than $60 billion) and the key business development executive at AskBio (recently acquired by Bayer in a $4 billion deal).
And world-renown scientific expertise …
Source 2: https://www.cantechletter.com/2021/01/antibe-therapeutics-has-a-massive-upside-echelon/
Source 3: https://antibethera.com/news/antibe-therapeutics-receives-fda-clearance-of-ind-application-for-otenaproxesul-for-osteoarthritis/
Source 4: https://www.cdc.gov/chronicdisease/resources/publications/factsheets/arthritis.htm
Source 5: https://bit.ly/31TOyw5
Source 6: https://antibethera.com/wp-content/uploads/2021/04/Antibe-Corporate-Presentation-April-2021.pdf
Source 7: https://antibethera.com/news/antibe-therapeutics-receives-fda-clearance-of-ind-application-for-otenaproxesul-for-osteoarthritis/
Source 8: https://www.businesswire.com/news/home/20210329005189/en/Antibe-Therapeutics-Receives-FDA-Clearance-of-IND-Application-for-Otenaproxesul-for-Osteoarthritis-Pain
Source 10: https://antibethera.com/news/antibe-therapeutics-announces-strategic-licensing-deal-in-china-with-nuance-pharma/
Source 11: https://stockcharts.com/h-sc/ui?s=ATE.TO
Source 12: https://antibethera.com/news/antibe-therapeutics-reports-q3-2021-interim-financial-and-operating-results/
Source 13: https://www.biospace.com/article/releases/antibe-therapeutics-receives-fda-clearance-of-ind-application-for-otenaproxesul-for-osteoarthritis-pain/
Source 14: https://antibethera.com/news/antibe-therapeutics-announces-closing-of-bought-deal-public-offering
Source 15: https://journals.lww.com/jaaos/Abstract/2018/05010/Mixed_Treatment_Comparisons_for_Nonsurgical.6.aspx
Source 16: https://www.arthritis.org/getmedia/73a9f02d-7f91-4084-91c3-0ed0b11c5814/ABTN-2020-FINAL.pdf
Source 17: https://finance.yahoo.com/news/antibe-therapeutics-receives-fda-clearance-110000132.html
Source 18; https://antibethera.com/news/antibe-therapeutics-announces-strategic-licensing-deal-in-china-with-nuance-pharma/
Source 19: https://www.marketwatch.com/investing/stock/ATBPF/financials/balance-sheet
Source 20: https://www.statista.com/statistics/784420/share-of-worldwide-pharma-revenue-by-country/
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Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation safer therapies to address inflammation arising from a wide range of medical conditions. The Company’s current pipeline includes three assets that seek to overcome the gastrointestinal (GI) ulcers and bleeding associated with nonsteroidal anti-inflammatory dr-ugs (NSAIDs). Antibe’s lead dr-ug, otenaproxesul, is entering Phase III for the treatment of osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-protective alternative to low-dose aspirin. The Company’s next target is inflammatory bowel disease (IBD), a condition long in need of safer, more effective therapies.