Vascarta commences a Phase I clinical study of VAS101 in osteoarthritis

SUMMIT, N.J. , March 18, 2025 /PRNewswire/ -- A 60-patient, randomized, double-blind, placebo-controlled phase I clinical study of VAS101 (topical curcumin gel) in osteoarthritis (OA) is underway. The study is being conducted at Clinical Research Australia, in Perth, Australia, under the direction of Dr. Adrian Lopresti, the Principal Investigator.

To date, a total of 19 patients have initiated treatment to receive either VAS101 or placebo once every two days for 28 days. Pending positive results, a Phase II study in OA is anticipated to start in 2026.

The primary study objective is to assess the safety and tolerability of VAS101 on knee pain in adult patients with chronic knee osteoarthritis. Secondary study objectives include evaluating the effect of VAS101 on symptom resolution, quality of life, and daily function; changes in the use of analgesics; and the presence of type II collagen cleavage products (CTX-II).

Dr. Adrian Lopresti, Principal Investigator, Clinical Research Australia, stated that: "This is a robust clinical trial where we are utilizing the gold-standard, randomized, double-blind, placebo-controlled study design. We are also using validated objective and subjective outcome measures to examine the therapeutic efficacy of VAS-101. Therefore, if the results are positive, it will provide strong support for the beneficial effects of VAS-101 for the alleviation of symptoms associated with knee OA."

About VAS101

Curcumin has well-known anti-inflammatory and pain alleviation properties. It is often taken orally to treat OA.  It has been demonstrated to reduce the need for pain relieving medication for the treatment of knee pain.  However, oral curcumin exhibits poor bioavailability which limits its efficacy.  VAS101 is a highly concentrated curcumin gel formulation that employs a patented topical/transdermal delivery platform designed to increase bioavailability both locally and systemically.  Preclinical studies (data on file) found that topically applied VAS101 results in measurable sustained drug levels of curcumin in both the plasma and blood cells that resulted in effective analgesia in an animal model. * 

About Osteoarthritis of the Knee

In healthy individuals, cartilage provides a natural cushion between joints. In OA, cartilage, and its shock absorbing effect, deteriorates resulting in pain, stiffness, swelling, and reduced mobility.  During the 2019–2021 timeframe, 53.2 million (21.2%) U.S. adults aged ≥18 years had diagnosed arthritis per the Unites States Centers for Disease Control. Further, the knee is the most frequently affected joint per the World Health Organization, Treatment of OA usually starts with lifestyle changes (weight loss, exercise) and/or over-the-counter analgesic/anti-inflammatory agents (acetaminophen, ibuprofen, naproxen), or physical therapy.  As OA progresses, treatment becomes increasingly invasive including injections of corticosteroids, hyaluronic acid, or platelet-rich plasma into the knee.  Surgical knee replacement or experimental therapies such as the injection of mesenchymal stem cells, bone marrow aspirate concentrates, autologous cultured chondrocytes, or botulinum toxin may be suggested as less invasive therapies wear off. A non-invasive, convenient, safer and more effective option is needed to reduce pain and improve quality of life in the elderly intolerant to NSAIDs.

Dr. Joel Friedman, Professor, Department of Microbiology & Immunology, Albert Einstein College of Medicine, and Vascarta Scientific Founder & Head, Scientific Advisory Board, stated, "It is anticipated that the effective targeting of multiple pain generating pathways both locally and systemically through topically applied VAS101 will provide a substantial benefit to sufferers of knee OA especially those for whom oral NSAIDs are not a viable option." [Dr. Friedman is the inventor of VAS-101 which is exclusively licensed to Vascarta from the Albert Einstein College of Medicine (Bronx, New York, USA).]

Dr. Richard Prince, Vascarta Chairman, CEO & President, commented that, "Osteoarthritis is very common.  It is suffered by 8% of the total global population and is suffered especially by older adults, 23% of those aged 50-69 and 38% of those aged 70+. We look forward to evaluating the OA clinical results from the study later this year. The study results will help guide the continued development of VAS-101 into an eventual FDA-approved therapy."  

* "Targeting sickle cell pathobiology and pain with novel transdermal curcumin"
https://academic.oup.com/pnasnexus/article/4/2/pgaf053/8010891

About Vascarta

Vascarta is a clinical stage pharmaceutical company exploring efficient transdermal delivery of pharmaceuticals to address inflammatory conditions with an initial focus on osteoarthritis and sickle cell disease.  For those interested in learning more about Vascarta's clinical programs, contact Chairman, CEO & President Dr. Richard Prince at rprince@vascarta.com.  Media requests should be directed to David Hymson at dhymson@vascarta.com.

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SOURCE Vascarta Inc