Frontier Biotech Reports Primary Endpoint Met in Phase 2 Trial of AB001 In Chronic Low Back Pain
NANJING, China, June 22, 2016 /PRNewswire/ -- Frontier Biotechnologies Inc. today 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.
About the Phase 2 Trial
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.
About Frontier Biotechnologies Inc.
Frontier Biotech is a research-based pharmaceutical company dedicated to the development and commercialization of next-generation therapeutic products addressing significant unmet medical needs. Its lead product candidate Albuvirtide, a novel long-acting anti-HIV agent, is in Phase 3 trial in China and an NDA is planned to be submitted to China FDA in 2016. Its second lead product candidate AB001 has been developed in the US. A Phase 1 clinical trial was successfully completed and data demonstrated great skin penetration with strong local "depot" effect. Steady-state PK showed a desirable control-release fashion. Systemic exposure of API was only a small fraction of that of the approved oral dose, providing great safety profile.
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SOURCE Frontier Biotechnologies Inc.