Interstitial Cystitis (IC) is a painful bladder syndrome in which inflamed and irritated bladder cause recurring discomfort or pain. The symptoms of IC include an urgent or frequent need to urinate and pain during bladder filling. Women are more prone to develop this condition. Pain may be mild or so severe as to be debilitating and it can vary from day to day. IC is categorized into non-ulcerative and ulcerative. Non-ulcerative IC is the most common condition found in 90% of IC patients. It causes pinpoint hemorrhages in the bladder wall. Ulcerative form of IC patients comprises 5% to 10% of IC that usually have red Hunner's ulcers or patches on the bladder wall. The exact cause of IC is unknown. Urinary tract infection due to bacteria and bladder overextension can trigger the painful condition in IC. Nerve injuries in the surrounding area of bladder or spinal cord can also cause IC.
There are many treatment options available to relieve the bladder pain symptoms, urgency, and frequency. In combination therapy, heparinoid drugs along with other oral medications help to restore integrity of the bladder lining. The symptomatic treatment includes over-the-counter medicines, topical medicines and narcotic pain medicines. Regular exercise, acupuncture, healthy diet and self-management are some of the non-pharmacological treatment used to control symptoms of IC.
There are more than 20 drugs present in the IC pipeline. In pipeline analysis, drugs are analyzed based on route of administration, and molecule type. The pipeline is also analyzed based on monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-Clinical stage.
Phase III clinical trial known for the comparison of new treatments with the standard treatment in which the safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. Aquinox Pharmaceuticals Inc. is developing AQX-1125, a Phase III clinical trial drug candidate for the treatment of IC disease.
Urigen Pharmaceuticals Inc. is developing URG-101, a Phase II drug candidate for the treatment of IC. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. It takes around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.
Astellas Pharma, Inc., is developing ASP 6294, a Phase I drug candidate for IC. The drug candidate is administered by intravenous and subcutaneous mode of administration. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.
Third-Generation Antisense program is a preclinical drug candidate of Idera Pharmaceuticals, Inc, which is using gene silencing oligonucleotides (GSOs) technology. Preclinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Pre-clinical study is of two types, including In vitro and In vivo.
Pipeline analysis provides description about the key companies which are developing drugs for IC. Some of the key players actively involved in the research and development are Lipella Pharmaceuticals, Inc., Mundipharma Research GmbH & Co KG, Urigen Pharmaceuticals Inc., Astellas Pharma, Inc. and MediciNova, Inc.