BioChemics Announces Positive Phase 2 Data for a Novel Transdermal Ibuprofen Drug Formulation Developed to Treat Osteoarthritis

DANVERS, Mass.--(BUSINESS WIRE)--BioChemics, a specialty pharmaceutical company, announced today that it has successfully completed a 14-day Phase 2 study in Switzerland demonstrating the efficacy of BioChemics’ transdermal ibuprofen-VALE® cream, BC-IBU-CH-001, for the treatment of osteoarthritis (“OA”). Like the US, a Phase 2 study in Switzerland looks at the efficacy of the drug as well as continuing to look at the safety profile established in the Phase 1 trial. BC-IBU-CH-001 is a transdermal preparation containing 10% ibuprofen. The tissue target for the drug in this clinical trial was a localized delivery to the arthritic tissue of the knee, with the goal of maximizing drug delivered to the inflamed knee tissue and also minimizing systemic delivery with a second goal of minimizing side effects, including gastrointestinal complications.

“We believe our ibuprofen formulation, with its efficacy and targeted tissue delivery, minimizing systemic exposure to the active ingredient, has the potential to offer physicians a first line therapy in the treatment of osteoarthritis.”

Results from the Phase 2 multicenter, randomized, double blind, efficacy study performed by PFC Pharma Focus (an independent Contract Research Organization) in Switzerland showed that patients with OA of the knee treated twice daily with the ibuprofen-VALE® preparation on the knee demonstrated substantial improvement in pain. Findings from the trial showed that patients receiving the transdermal ibuprofen-VALE® preparation achieved a greater statistically significant reduction in pain on the WOMAC Osteoarthritis Index at 14 days than those receiving the placebo (p=0.0201). It was also reported that treatment with the ibuprofen-VALE® preparation was generally very well tolerated through 14 days of treatment.

Investigators at PFC Pharma reported data from the Phase 2 study in which patients were randomized to receive transdermal ibuprofen-VALE® or placebo twice daily for 14 days. By day 14, the transdermal ibuprofen-VALE® cream had, on average, a 60.6% greater reduction in pain from the baseline than the placebo on the VAS pain scale. Findings also showed the transdermal ibuprofen-VALE® cream had, on average, a 117% greater reduction from the baseline than the placebo on the Total WOMAC scale.

OA, the most common form of arthritis, affects an estimated 27 million Americans and more than 151 million people worldwide are affected by the condition, for which there is no cure.

“What is exciting for us is that we are looking at a 14 day time period in order to reduce pain on individuals with moderate to severe osteoarthritis pain,” said BioChemics President and CEO John Masiz. “In contrast, it appears to us that most clinical trials with pain at this level are conducted for 90 to 120 days to ensure achieving a positive clinical endpoint. In addition, the amount of active drug that was delivered into the patient was significantly less than traditional oral therapy. For example, with our VALE® technology, BioChemics treated each patient with 400 mg of ibuprofen per day (200 mg twice daily); compared to an oral prescriptive treatment regimen of ibuprofen, which can be as much as 3,200 mg per day (four 800 mg capsules). This results in substantially less systemic exposure to the active drug and combined with avoidance of the gastrointestinal system could logically translate to fewer side effects.”

“We are pleased with the results that we have seen thus far with our transdermal ibuprofen-VALE® cream,” said Masiz. “We believe our ibuprofen formulation, with its efficacy and targeted tissue delivery, minimizing systemic exposure to the active ingredient, has the potential to offer physicians a first line therapy in the treatment of osteoarthritis.”

About the Phase 2 Study

The Phase 2 study was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy of BC-IBU-CH-001, an ibuprofen-VALE® cream administered transdermally in subjects with moderate to severe osteoarthritis (OA) pain. In the Phase 2 study, 75 subjects were randomly assigned in a 1:1 fashion to receive either transdermal ibuprofen-VALE® cream or placebo cream twice daily for 14 days. The symptoms were reviewed every seven days by investigators throughout the 14 day study.

About BC-IBU-CH-001

BC-IBU-CH-001 is a 10% transdermal ibuprofen preparation formulated with BioChemics’ VALE® technology for the treatment of osteoarthritis (OA).

About BioChemics, Inc.

BioChemics is a pharmaceutical company that has developed novel topical and transdermal drug delivery systems that for the first time may allow a portfolio of previously transdermally undeliverable drugs to be efficiently delivered through the skin. The drug delivery technology called VALE® (Vaso-active Lipid Encapsulated) may allow many drugs to be re-engineered, transforming oral drugs into transdermal or topically-applied drugs that are potentially more efficacious, and safer, than oral equivalents. The company's focus is on large medical market opportunities currently underserved by existing therapies.