Medinox Inc hascompleted a Phase 1 safety trial in Europe of MX-1094, a Non-Steroidal Anti-Inflammatory prodrug (NSAID) in development for the treatment of arthritis.
The trial was a randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study and its objective was to evaluate the safety profile, tolerability and pharmacokinetics of MX-1094 in healthy volunteers. Medinox has completed the analysis of clinical data obtained from 48 healthy volunteers in the Phase 1 trial. The results show that MX-1094 is well-tolerated and exhibits the desired pharmacokinetic profile when compared to naproxen.
Based on the data from the Phase 1 trial, the Company intends to conduct additional trials to further evaluate the gastrointestinal safety of MX-1094 compared to naproxen.
The Medinox prodrug program is addressing the need for safer and effective NSAIDs. NSAIDs such as aspirin, naproxen and diclofenac are an important class of analgesic and anti-inflammatory compounds that are among the most widely used medicines in the world. Despite their proven clinical efficacy and wide use, NSAIDs have limitations, especially for patients undergoing long-term NSAID therapy. The main problems are upper gastrointestinal ulcers that are a frequent side effect of NSAID therapy and are responsible for 107,000 hospitalizations and 16,500 deaths annually in the US.
In addition to MX-1094, Medinox is also in pre-clinical evaluation of other NSAIDs using the Company's patented linker technology.
"Our NSAID prodrugs have the potential to be widely used not only as safer therapies for pain and inflammation but also for other new indications, which were previously not possible due to the GI toxicity of conventional NSAIDs," said Monte Lai, Medinox President & CEO. "We believe that MX-1094 will meet the need for safer NSAIDs and has the potential to be a leading clinical therapy."