FyMed Demonstrates Superiority of FY101C over Ibuprofen and Naproxen in the Treatment of Pain and Inflammation
July 23, 2012- Wilmington, DE -FyMed, Inc., a pharmaceutical company with specialization in innovative evidence-based approaches in drug discovery, today announced successful completion of comparative in-vivo studies for FY101C, its proprietary lead candidate in the non-steroidal anti-inflammatory (NSAID) category. FY101C demonstrated profound therapeutic effects in the management of acute and chronic pain and inflammation, and was found to be significantly superior in terms of efficacy and safety to conventional NSAIDs.
FY101C was identified by FyMed through a proprietary drug discovery process and further developed through extensive mechanism of action studies that integrates advanced pharmacogenomics and proteomics in various in-vitro and in-vivo models of pain and inflammation. In these models, FY101C demonstrated profound anti-inflammatory activity by suppressing a unique panel of mediators that were activated via the NF-κB (nuclear factor kappa-light-chain-enhancer of activated B cells) and p38 MAPK (mitogen-activated protein kinase) pathways, which are germane to many inflammatory conditions. Through the modulation of these molecular mechanisms, FY101C was further found to regulate steady-state levels of COX (cyclooxygenase) and PGs (prostaglandins), key targets of NSAID therapy.
FyMed had previously completed preclinical studies on FY101C. Recent developments however prompted the Company to perform further comparative studies of FY101C with that of ibuprofen and naproxen in terms of efficacy and safety using multiple in-vivo models of acute and chronic pain and inflammation. Treatment with FY101C showed statistically significant cumulative reductions of the clinical severity of arthritis, pain, and gastrointestinal toxicity at a level of efficacy and safety that was superior to ibuprofen (p=0.008) and naproxen (p=0.01).
These results were further validated through independent histological, radiological, and systemic assessments. Of note, treatment with FY101C exhibited significantly low gastrointestinal mucosal leakage and erosions when compared to ibuprofen and naproxen. These new findings demonstrate the superiority of FY101C over conventional NSAIDs in terms of efficacy and safety for the treatment of pain and inflammation.
While proof-of-concept clinical trials on FY101C in rheumatoid arthritis are currently underway, these new discoveries support the advancement of FY101C to comparative Phase 2b trials. Through strategic partnerships and recent expansions, FyMed applies integrated molecular phenotypic based innovative approaches in clinical trials with companion prognostic driven drug-centric modalities.
FyMed, Inc. is a pharmaceutical company with a growing portfolio of novel and improved pharmaceuticals developed and enhanced through ultra-sensitive next generation targeted companion diagnostics and prognostics. Leading innovations in personalized medicine has enabled FyMed to effectively balance technological innovation with scientific discovery, creating tools that can productively integrate with drug development and capitalize on key market deficiencies.
Safe Harbor Statement
To the extent any statements made in this document contain information that is not historical, this news release contains "forward-looking statements" within the meaning of Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of the words "intends," "plans," "will," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described herein. These risks and uncertainties may include, without limitation, projected expansions, outcomes of our clinical trials, achievement of our business objectives, and the ability to obtain necessary regulatory approvals. FyMed undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Media Relations, FyMed, Inc.
3422 Old Capitol, Suite 1610
Wilmington, DE 19808
Posted: July 2012