Pharmos discovers and develops novel therapeutics to treat a range of indications with a focus on specific diseases of the nervous system including disorders of the brain-gut axis (GI/IBS), pain/inflammation, and autoimmune disorders.
The Company's lead product, dextofisopam, is being developed as a treatment for irritable bowel syndrome (IBS), which remains a dramatically underserved treatment market in the U.S. and abroad. Unlike the newer IBS therapies currently available, dextofisopam's novel non-serotonergic, brain-gut mechanism offers a unique and innovative approach to IBS treatment. In June 2007, the Company commenced a Phase 2b study of dextofisopam, which is expected to enroll approximately 480 female patients with diarrhea-predominant or alternating IBS. The Phase 2b study follows a successful Phase 2a study in 141 IBS patients in which dextofisopam demonstrated a statistically significant improvement (p=0.033) over placebo on the primary endpoint of adequate overall relief. Affecting 10-15% of US adults, IBS is a large market with significant direct and indirect costs, and limited treatment options.
Pharmos' core proprietary technology platform focuses on discovery and development of synthetic cannabinoid compounds. Compounds from the Company's extensive library of cannabinoids are being tested in preclinical studies. Pharmos' synthetic cannabinoid library encompasses two major classes. The first of these consists of families based on several distinct chemical scaffolds that preferentially bind to the cannabinoid 2 (CB2) receptors. Because CB2 receptors are mainly present in cells of the immune system, Pharmos is evaluating the potential of CB2-selective cannabinoid compounds as analgesics and as immunomodulators for treating inflammation and autoimmune diseases. The second class consists of dextrocannabinoids, which do not bind appreciably to cannabinoid receptors. Members of this class act as non-competitive NMDA antagonists and anti-oxidants, and also have the ability to block production of inflammatory cytokines. Members of this class have potential as anti-inflammatory and neuroprotective agents with possible applications in neuroinflammation.
PRS-639,058, the leading CB2-selective agonist, has demonstrated promising preclinical data in neuropathic pain. Various other CB2-selective compounds from Pharmos' pipeline are in preclinical studies targeting pain, multiple sclerosis, rheumatoid arthritis, inflammatory bowel disease and other disorders.
Pharmos is also working to commercialize its unique, proprietary NanoEmulsion (NE) drug delivery system. A Phase 2a study of NE formulated with 3% diclofenac, a widely used non-steroidal anti-inflammatory drug (NSAID), in osteoarthritis patients is underway with data expected mid-2008. The NE drug delivery system is a solvent-free topical vehicle based on stable, submicron particles of oil-in-water emulsions with high solubilization capacity for water-insoluble compounds. Topical delivery of certain analgesic compounds is expected to improve the therapeutic window compared to oral administration. Strategically, the NE program broadens the Company's development pipeline and carries with it a reduced technical risk for products having significant market potential. Osteoarthritis affects roughly 12% of U.S. adults, many of whom do not receive pharmacological treatment due to side effects associated with the commonly used oral medicines.
