Ion Channel Innovations (ICI) is licensed for global development and promotion by hMaxi-K

OAB is considered a smooth muscle disease of the genitourinary system, and by regulating smooth muscle tone, the relaxation of high-strained organs can serve therapeutic purposesOAB, characterized by clinical symptoms such as urinary urgency, urinary frequency and urinary incontinence, is often difficult to treat because its etiology is unknownIn the United States, more than 30 million people over the age of 40 are affected by OAB symptomsOAB symptoms can trigger depression, anxiety and other negative emotions, and seriously affect the quality of lifeSeven out of 10 patients stopped taking the drug within 6 months because they could notthe(side effector or dissatisfaction with the outcome of the treatment)These patients need effective and innovative alternative therapiesClinical Stage Bio
Medicines(Company(announced global development and promotion of hMaxi-K from Ion Channel Innovations (ICI)hMaxi-K is a gene therapy in the study used to treat bladder hyperactivity disorder (OAB)Currently, there is noFDA(approved gene therapy for the treatment of OAB)hMaxi-K is a "naked" DNA plasmid that carries the cDNA of the human hSlo gene, which encodes the alpha sub-units of the Maxi-K channel that smooth the muscle highly conductive potassium ions (Maxi-K) 　　The Maxi-K channel is a 4 polymer formed by two alpha subprimes and two beta sub-bases, through which alpha sub-bases form a channel hole through which potassium ions pass through the cytoplasmic membrane, and the beta sub-subtype regulates the entry and exit of potassium ions in response to calcium ion levels in the cell preclinical studies show that the expression of the alpha sub-type only composed of the channel can achieve cell membrane hyperpolarization, reduce smooth muscle cell tension, as well as the physiological effects of relaxation organs "Naked" DNA plasmids can be absorbed into the nucleus of smooth muscle cells, and in turn, on the smooth muscle cell membrane, synthesis (a large number of Maxi-K potassium ion channels) Because this improvement in relaxation smooth muscle function comes from a change in the nature of muscle cells, the therapeutic effect can last for 6 months 　　Previous ICI studies have shown that hMaxiK improves the pathophysiology of the genitourinary tract in rodent and non-human primate models of old age, diabetes and atherosclerosis studies
hMaxi-K have treated OAB patients in two Phase 1 studies, including a small, double-blind, placebo-controlled, 1b clinical trial (a 1b clinical in which OAB female patients were injected with in-bladder injections) THE ICI completed a Phase 1b trial involving 13 patients in 2017 The results showed an improvement in dose dependence on urinary acute and frequent urinary frequency symptoms and statistical significance in the high-dose group (p 0.05), in addition to hMaxi-K's usually good tolerance Urovant plans to meet with the FDA in 2019 and initiate phase 2 trials in Patients with OAB who sit no response to other drugs