Frontier Biotech Reports Primary Endpoint Met in Phase 2 Trial of AB001 In Chronic Low Back Pain

PR64862

NANJING, China, June 22, 2016 /PRNewswire=KYODO JBN/ --

-AB001 demonstrated statistically superior and clinically meaningful pain

relief against placebo at week-2-

-AB001 also achieved statistical significance against placebo on pain relief at

week-1, Roland-Morris Disability Questionnaire Score at week-2 and Subject

Global Perceived Treatment Effect at week-1 and week-2-

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.

Source: Frontier Biotechnologies Inc.