Diseases and Products | Interstitial Cystitis
Quick Links:
Disease Overview:
Interstitial cystitis (IC) is a chronic sterile disease of the bladder characterized by urinary frequency, urgency, nocturia (night-time urination) and pelvic and bladder pain. The most common theories to explain the pathophysiological changes in IC are an altered bladder lining (defective glycosaminoglycan layer) and an increased number of activated bladder mast cells.
Symptoms vary between patients and may vary between episodes in the same patient. The average patient has symptoms for 5 years and visits multiple clinicians before a diagnosis of IC is made. Patients may have extended periods of remission; IC is not a progressive disease.
Sufferers of IC can experience any combination of the main symptoms of the condition, and no two people may have the same combination or severity of symptoms. IC patients are more prone to suffer from other medical conditions than would be expected in the general population.
The severity of the overall symptoms can considerably affect the quality of life of IC patients and seriously restrict their ability to undertake everyday tasks that are taken for granted by the majority of the population. The impact can be seen by the level of depression experienced by IC patients.
Market Overview:
According to the National Kidney and Urologic Diseases Information Clearinghouse, which is a division of the National Institutes of Health, an estimated 1,000,000 patients suffer from IC in the United States, 90% of whom are women. The prevalence of IC in Europe is approximately one-third that of the United States. We believe that IC is currently underdiagnosed and that the market for drugs that treat IC will likely expand with the introduction of effective new treatments.
At present, there is no cure for IC and no treatment that works for every IC patient. Treatments are only designed to relieve the aggravating symptoms of IC. As a result, there are no truly effective treatments for the majority of sufferers.
Elmiron® and DMSO are the only medications approved by the Food and Drug Administration (FDA) for the relief of bladder pain or discomfort associated with IC. Elmiron is typically taken as a tablet 3 times per day. Elmiron is believed to repair/replenish the bladder wall, which minimizes the irritation of the bladder lining. For most patients treated with Elmiron, it may take many months before any benefit is experienced. DMSO is injected intravesicularly to reduce bladder inflammation.
MN-001 for the Treatment of Interstitial Cystitis:
MN-001 is a novel, orally bioavailable compound under development for the treatment of IC. In preclinical testing MN-001 was shown to block a number of the inflammatory mechanisms activated by mast cell degranulation that are important in the pathogenesis of inflammatory disorders including IC and asthma (e.g., leukotriene receptor antagonism and inhibition of phosphodiesterases III and IV, 5-lipoxygenase, phospholipase C and thromboxane A2). MN-001 produced anti-inflammatory effects in a variety of rodent models of IC and asthma; in these models, MN-001 reduced bladder hyper-reactivity much in the same way that it reduces airway hyper-reactivity in the lung.
In May 2005, MediciNova initiated a randomized, double-blind, placebo controlled Phase II/III clinical study of MN-001 for the treatment of IC. A total of 305 patients were enrolled in this study. In January 2007, MediciNova reported results of this Phase II/III study for MN-001. Although MN-001 was well-tolerated in this study, it did not show a statistically significant clinical benefit compared to placebo on the primary endpoint (to be much or very much improved overall on a patient-rated Global Response Assessment) at the doses tested in this trial (500 mg once or twice a day for 8 weeks).
Results from this Phase II/III trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day compared to placebo (25% compared to 12%, p=0.04) after 4 weeks of treatment. This difference, however, was not observed at 8 weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500 mg of MN-001 once a day did not significantly differ from placebo at either 4 or 8 weeks.
We will limit our development efforts on MN-001 for the treatment of IC to those activities necessary to maximize MN-001’s value while pursuing a variety of initiatives to monetize this product candidate.
More Information
Click for more information on the following items:
Core Candidates:
Non-Core Candidates:
