Antares Pharma, Inc. (NASDAQ: ATRS) today announced positive results from an Actual Human Use (AHU) study for VIBEX Methotrexate (MTX). The clinical trial was conducted as a multi-center, open-label, single-arm, in-clinic study to evaluate the actual human use of methotrexate administered via the VIBEX Medi-Jet in adult patients with rheumatoid arthritis (RA).
The study assessed the safe usability of VIBEX MTX for self-administration of parenteral MTX in adult RA patients after standardized training by site personnel and review of written instructions. Secondary objectives included evaluation of the reliability, ease of use and robustness of the VIBEX Medi-Jet; assess the safety and local tolerance of Medi-Jet administered MTX and to evaluate the effectiveness of the patient education tools including written instructions for use.
"We believe that the successful completion of this study is important for Antares as we continue to build our company and further control our key product programs," said Paul K Wotton, Ph.D., President and Chief Executive Officer. "The performance of the VIBEX Medi-Jet in this clinical study also validates our technology platform upon which we are developing multiple products like MTX and Testosterone, optimizing treatment options and allowing patients to self-administer parenteral medications conveniently at home and potentially reduce overall healthcare costs."
The Actual Human Use study consisted of three visits over nine days and included a screening period, a treatment period and a follow-up visit. In total, 101 patients were enrolled in four study dose groups, 10 mg. (n=20), 15 mg. (n=30), 20 mg. (n=31) and 25 mg. (n=20). The single MTX dose was self-administered by the patient from one of the four dose groups using the VIBEX Medi-Jet.
The results of this study show that self-administration of MTX using the VIBEX Medi-Jet is safe and well tolerated. Following standardized training by site personnel and review of written instructions, all 101 patients performed the self-administration successfully. In addition, the VIBEX Medi-Jet functioned correctly and as intended for each and every administration thereby demonstrating reliability and robustness. Results of the Ease of Use Questionnaire indicated that 98% of patients found the VIBEX Medi-Jet easy to use and 100% of patients found the instructions and training to be clear and easy to follow. Patients were also asked to report site administration pain at the end of the treatment period. Administration site pain was measured using a 100 mm Visual Analog Scale (VAS) and showed that patients experienced minimal or no pain with a mean value of 3.6 mm on a scale of 100 mm. Importantly, no patients experienced treatment-emergent serious adverse events related to the drug.
"We are extremely pleased with the results of the Actual Human Use study," said Kaushik J. Dave R.Ph., Ph.D., and Executive Vice President Product Development. "The study demonstrated that rheumatoid arthritis patients were able to successfully self-administer MTX with the VIBEX Medi-Jet which we believe is safe, well tolerated and easy to use. These study results along with the positive Usability Study results previously reported in patients with severe to very severe hand function impairment keep us on schedule for an early 2013 filing of the New Drug Application for VIBEX MTX, a potential new treatment option for patients who suffer with RA."
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