Press Release: Vizuri Health Sciences LLC to Present CGS-200-5 Knee Pain Results at the American College of Rheumatology Annual Meeting
FAIRFAX, VA.–(BUSINESS WIRE)–Vizuri Health Sciences LLC, a pharmaceutical development company, today announced that it has been selected to make an oral presentation of findings from a randomized, double-blind Phase 2 osteoarthritis (OA) knee pain study (VZU00025, NCT03528369) at the American College of Rheumatology and the Association of Rheumatology Health Professionals’ 2019 Annual Meeting, which will take place from November 8-13 in Atlanta, Georgia. Details of the presentation are shown below.
Abstract Title (#2760): A Phase 2 Double-Blind Clinical Trial to Examine the Comparative Effects on Osteoarthritic Knee Pain of CGS-200-1 (1% Capsaicin Topical Liquid), CGS-200-5 (5% Capsaicin Topical Liquid), and CGS-200-0 (Vehicle, No Capsaicin)
Session: Osteoarthritis – Clinical II: Novel Therapies
Date, Time, and Location: Tuesday, November 12, 2019, from 3:30 PM – 3:45 PM in Room B206
Full meeting abstracts can be viewed on-line at ACR abstracts.org.
Abstract #2760 reports that CGS-200-5 was well-tolerated and was efficacious. Efficacy and safety highlights will be presented at the ACR meeting, including:
• As shown in the table below, CGS-200-5 met the primary Day 35 WOMAC pain efficacy endpoint compared to vehicle (p = 0.020) and post-hoc analysis showed statistical separation from vehicle on Days 64 (p = 0.0001) and 94 (p = 0.0111) following application to the knees on Days 1-4.
• Post-hoc analysis showed a statistical decrease in WOMAC OA total score (a composite index of knee pain, stiffness, and function) for CGS-200-5 compared to vehicle at Days 35, 64 and 94.
• The proportion of CGS-200-5 subjects with a Day 94 durable clinical response (WOMAC pain reductions > 50% on at least 4 of 5 study day visits) was 29.3% (p = 0.1004 compared to vehicle).
Marc C. Hochberg, MD, MPH, MACP, MACR, Professor of Medicine and Head of Rheumatology and Clinical Immunology at the University of Maryland School of Medicine, observed, “Given the emphasis on the use of topical agents as first choice for the local treatment of pain associated with knee osteoarthritis, as noted in both the 2019 American College of Rheumatology and 2019 Osteoarthritis Research Society International recommendations, these data suggest that CSG-200-5 will be a useful first-line treatment for patients with knee osteoarthritis.”
According to the Centers for Disease Control and Prevention, OA is the most common joint disease in the United States, currently affecting more than 30 million Americans. OA most often affects joints in the knees, hands, hips, and lower back and neck. OA is due to cartilage deterioration within the joint and causes pain, swelling and declines in flexibility and overall function. Over time, patients with knee OA tend to become inactive due to pain, joint stiffness and reduced function. Inactivity due to OA is associated with health risk conditions such as cardiovascular disease, diabetes, and obesity.
CGS-200-5 is a patented, next-generation, high potency topical treatment for the relief of OA and is wholly owned by Vizuri. It is being developed to address the high unmet medical need for an OA pain treatment that is highly and durably effective, can be self-administered, does not require everyday use and that is safe (e.g., without the gastrointestinal, liver or addiction risk associated with other common treatments).
About Vizuri Health Sciences LLC (www.vizuriusa.com)
Privately-owned Vizuri develops new innovative healthcare products that utilize proprietary formulations to enhance the efficacy or safety of pharmaceutical ingredients that have proven health benefits.
William Moore, CEO
From National Harbor to downtown Silver Spring, Fair Lakes-based The Peterson Cos. has been behind some of the most transformative real estate developments in the region.
Now the company is working to make a national impact in a completely different market — by developing health products for seniors.
In recent months, its biotech venture called Vizuri Health Sciences LLC has gained a toehold in the massive market of over-the-counter drugs, inking several deals to get its first pain relief product on pharmacy shelves across the country.
With those deals, Vizuri seeks to tap into the $700 million topical analgesic market and capture growing demand among an aging population seeking alternatives to opioids, said Rick Peterson, who oversees The Peterson Cos.’ growing list of non-real estate holdings.
“What we like to say is we bring cost-effective, natural alternatives to the market that allow baby boomers to age gracefully,” he said.
How it started
How the heck did a development company get into the health world?
Peterson Cos. has invested in all manner of things over the years, from a shrimp farm in Belize to “National Geographic Encounter: Ocean Odyssey,” a digital experience in New York City’s Times Square.
Peterson said this venture into health care dates back well over a decade, to his father Milt’s 50th high school reunion, where he reconnected with old friend Dr. Charlie Birbara, the high school valedictorian. About five years after the reunion, Birbara — a pain physician who also ran clinical trials for drug companies — told Milt about a skin repair compound created by his brother and former NASA chemist Phil Birbara.
The compound, called apigenin, is a nutrient typically found in fruits and vegetables.
They dubbed their startup, founded in 2009, Vizuri.
Peterson ran the company from the Peterson Cos.’ Fair Lakes headquarters for several years, evolving the science and obtaining the patents until the team was ready to develop a go-to-market strategy. They brought on biotech veteran William Moore to serve as Vizuri’s CEO and president. They brought on experts in patents and marketing. They opened an office at the University of Maryland UM BioPark incubator in 2014.
Even as they were working to take apigenin to market, Phil Birbara came up with another patented product. This one was for pain relief using a common ingredient known as capsaicin, the active component in chili peppers that makes them hot.
Other over-the-counter pain relievers use capsaicin for pain relief, but only in small concentrations because the burning sensation it causes is often intolerable. Birbara, however, invented a product with the highest concentration of capsaicin allowed without a prescription — minus the side effect. They named it PainBloc24.
Seeing a faster pathway to market with PainBloc24, the Vizuri team reprioritized it over the apigenin product, Rick Peterson said.
“In essence, you could say we’re taking natural products that have historically had a problem associated with them and the medical community tends to know them pretty well,” he said. “But they’ve got one problem or another. We solve that problem, and it allows them to come to market.”
Coming to a store near you
In September, Vizuri piloted PainBloc24 in a chain of New York grocery store pharmacies and began growing from there. This quarter, the company said, the product expanded to 15,000 stores around the country, including CVS Pharmacy, Rite Aid Pharmacy and Kroger.
“Finding a way to make capsaicin tolerable, a non-opioid alternative got CVS’ ear,” said Moore, Vizuri CEO. “There are a lot of pain products out there that have limited efficacy, and so people who are in pain are always looking for new treatments and therapies. So, it got a lot of the retailers’ attention. We’re considered innovators out there.”
The product sells for between $9 and $18 a bottle depending on the size.
“I find myself looking for it in any store I go by now,” said Rick Peterson, who recently spotted it on a CVS shelf at National Harbor. The team hasn’t yet published its clinical studies documenting the effectiveness of the product but expects to within the next three months. Those will demonstrate, he said, that it offers 24-hour pain relief.
Vizuri also launched a process with the Food and Drug Administration to win approval for a prescription-strength concentration of PainBloc and are seeking a pharmaceutical partner for that effort. They are submitting clinical safety data gathered in a trial run in both the U.S. and the Dominican Republic and hope to have phase 2 clinical data by the end of the third quarter.
And Vizuri is now returning to the original compound that launched it all, apigenin, which it plans to market as a product called Skin Defense to be used for healing burn wounds or the treatment of dermatological conditions such as rosacea, which causes redness and visible blood vessels on a person’s face.
“It started with three guys who would now be in their 80s who basically said, ‘We want to create some products that allow guys like us have it easier as they get on in age,'” Rick Peterson said. “It’s just a cool story.”