Frontier Biotechnologies Inc reported that a phase 2 clinical trial for its novel patch product AB001 met primary endpoint at week-2, demonstrating statistically significant (p=0.023) and clinically meaningful pain relief against placebo. Conducted at nine clinical centers in the United States, the trial enrolled 146 patients with chronic low back pain.
AB001 also achieved statistically significant (1) analgesia against placebo at week-1 (p=0.024), (2) greater reduction than placebo in the mean Roland-Morris Disability Questionnaire score at week-2 (p=0.006), and (3) more subjects were satisfied (extremely, very, or somewhat) with study medication than that in the placebo group at week-1 (p=0.035) and week-2 (p=0.045). On average, 75% of the patients treated with AB001 experienced 34.1% reduction in pain from baseline at week-2, 50% of patients reduced 58.3% of pain, and 25% patients reduced 78.5% of pain. No drug-related serious adverse events were observed and the most common TEAEs were application site AEs, which occurred in 7 subjects (9.6%) in the AB001 group and 5 subjects (6.9%) in the Placebo group.
"Demonstrating superior pain relief against placebo is a challenge, especially for patch product, and there hasn't seen meaningful innovation in many years. We are very encouraged with these phase 2 data that strongly demonstrated AB001’s safety and clinical efficacy," said Dr. CJ Wang, Ph.D., chief executive officer of Frontier Biotech, “Millions of people in the U.S. suffer from the debilitating effects of chronic low back pain and many have to take oral NSAIDs despite their serious side effects in GI tract and increased risks in cardiovascular diseases. We believe that AB001 has the potential to become an important new non-steroidal anti-inflammatory drug (NSAID) patch product for the management of local pain and inflammation. We look forward to working closely with the U.S. Food and Drug Administration (FDA) on further development of AB001.”
AB001 is designed as a prescription-strength and best-in-class topical patch product for the treatment of acute and chronic muscle and joint pain and inflammation. It’s a third-generation patch product with patent-protected and non-hydrogel based matrix formulation for superior skin penetration and tissue permeability, anti-inflammation and pain relief potency. It has potential to effectively minimize systemic drug exposure and avoids unwanted side effects common to oral therapies. Current oral treatment options for chronic low back pain include NSAIDs and opioids. All are labeled with black box warnings for serious, sometimes fatal, side effects. It’s also friendly to all skin types and easy to use -- the novel matrix system is only ~200 mm thick.
It was a phase 2, randomized, double-blind, placebo-controlled, parallel-group, multi-center study designed to examine the safety and efficacy of AB001 topical patch in subjects with chronic low back pain. Study subjects were enrolled at 9 study centers in the US. One hundred forty-six subjects who met the study entry criteria were randomly assigned in a 1:1 ratio to receive either AB001 or placebo patches. Subjects applied 2 patches to their lower back once daily in the morning for 14 days. The patches were to be removed after 12 hours.