Avecho Biotechnology Limited announced positive results for its Phase IIa Study (the Study) examining the effects of its topically applied CBD formulation on the symptoms of osteoarthritis (OA). The Study was run by Principal Investigator, Dr. Daniel Lewis, from the Daniel Lewis Rheumatology Centre; and Co-Investigator, Professor Iain McGregor, from the Lambert Initiative, Australia's leading research group for the discovery, development, and optimisation of safe cannabinoid therapeutics. Hand OA is a common, painful, progressive, and irreversible condition that significantly impairs hand strength and function.

There are limited treatment options available and current therapies primarily involve symptom relief and preservation of function. Systemic administration of CBD has shown promise in animal models of OA, however, topical therapeutics are of particular interest in diseases such as OA due to their targeted application and avoidance of first-pass metabolism. Four week treatment with the company's proprietary topical CBD formulation resulted in highly significant improvements (p<0.001) in patient observed (i) reductions in pain, (ii) increases in grip strength, (iii) improvements in hand functionality, (iv) self-reported stiffness of the fingers and (v) self-reported anxiety.

Phase IIa Study Clinical Trial Results: The single-centre proof-of-concept trial investigated the effects of a topical CBD gel on symptomatic, painful OA of the hand, affecting the fingers and/or thumb. A group of 15 patients applied the company's proprietary TPM® formulation daily to the affected joints of a single hand. The Study was run over a 6 week period, including 1 week of baseline measurements, 4 weeks of treatment, and a subsequent 1 week of washout after the conclusion of dosing.

Participants were asked to complete a range of daily assessments. The primary outcome measure was the change from baseline in daily hand pain (average and maximum) as measured by the 10-point Numeric Pain Rating Scale (NPRS). The secondary objectives involved hand functionality including grip strength measured daily via an electronic squeeze ball dynamometer connected via Bluetooth to a smartphone-based recording app, and the Functional Index for Hand Osteoarthritis (FIHOA) score, completed at baseline and weekly until study exit.

The reduction in pain scores was highly significant (p<.001) for both the average daily NPRS pain scores (1.32-point difference, baseline = 4.38,) and maximum daily NPRS pain scores (1.62-point difference, baseline = 5.57). Improvements in grip strength and functionality were also highly significant (p<0.001) with functionality measurements (relative to the baseline) in the treated hand markedly improving during the first week of treatment and being maintained over the 4-week dosing period. Most participants also saw improvements in functional index for hand osteoarthritis (FIHOA) functionality scores with treatment.

Weekly declines in self-reported stiffness of the fingers and anxiety were also reported, with these changes over time also statistically significant (p<0.001) by the end of week 4.