Vascarta Starts Phase I Trial of Innovative Curcumin Gel for Osteoarthritis

Vascarta Begins Phase I Clinical Trial for VAS101 in Treating Osteoarthritis

Vascarta Inc. has announced the commencement of a Phase I clinical trial for VAS101, a topical curcumin gel specially formulated to alleviate knee pain related to osteoarthritis (OA). This randomized, double-blind, placebo-controlled study is being conducted with 60 patients at Clinical Research Australia in Perth, under the expert guidance of Dr. Adrian Lopresti, the Principal Investigator.

The trial will involve 19 patients receiving either VAS101 or a placebo every two days for a duration of 28 days. The primary goal is to assess the safety and tolerability of VAS101, while secondary goals include evaluating its effects on symptom resolution, quality of life, daily functioning, analgesic usage, and levels of type II collagen cleavage products (CTX-II).

Dr. Lopresti commented on the importance of utilizing a rigorous clinical trial design. He stated, "This is a robust clinical trial where we are employing the gold-standard design with validated outcome measures to evaluate the therapeutic efficacy of VAS101. Positive results may form a solid foundation for further development towards an eventual Phase II study in OA, projected to begin in 2026."

Understanding VAS101 and Its Development

Curcumin, a compound known for its anti-inflammatory and pain-relieving properties, has traditionally been consumed orally to help treat OA. Despite its benefits, oral curcumin suffers from poor bioavailability, which can limit its effectiveness. VAS101 is formulated to overcome these challenges through a patented topical/transdermal delivery system that enhances local and systemic absorption.

Preclinical studies have shown that VAS101, when applied topically, leads to sustained levels of curcumin in both plasma and blood cells, providing effective relief in pain models. This innovation could significantly improve treatment outcomes for OA patients.

The Impact of Osteoarthritis

Osteoarthritis remains a prevalent issue, affecting approximately 8% of the global population, with increasing rates among older adults—23% of individuals aged 50 to 69 years and 38% of those aged 70 and older. The disease leads to the deterioration of joint cartilage, causing pain, stiffness, and reduced mobility. The Centers for Disease Control and Prevention (CDC) reported that over 53 million U.S. adults had a doctor-diagnosed form of arthritis during the 2019-2021 timeframe.

Traditionally, OA treatment starts with lifestyle modifications or over-the-counter medications but may escalate to invasive procedures as the condition worsens. The introduction of a non-invasive, effective option like VAS101 could significantly enhance quality of life for elderly patients who cannot tolerate non-steroidal anti-inflammatory drugs (NSAIDs).

Looking Ahead: Expectations from VAS101

Dr. Joel Friedman, founding member of Vascarta and a key figure in its scientific efforts, predicted that VAS101 might target multiple pathways that generate pain, offering substantial benefits to OA sufferers. Vascarta's CEO, Dr. Richard Prince, echoed this optimism, stating that the study's outcomes could guide the continued development of VAS101 into a viable FDA-approved therapy. Further evaluations from this study are anticipated later this year, and they will influence the future treatment landscape for osteoarthritis.

Vascarta is dedicated to pioneering efficient transdermal methods to address inflammatory conditions and looks forward to advancing its work in OA and other diseases. For more information about Vascarta and its clinical endeavors, inquiries can be directed to Dr. Richard Prince or media requests to David Hymson.