新聞正文
Innovacell Inc. (https://innovacell.com/) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for the international joint Phase III clinical trial of ICEF15 (the Fidelia study), currently being conducted by the company group in Japan and Europe, has completed its 30-day review period, and that the trial can commence in the United States. This allows for the formal enrollment of U.S. sites and patients in the Fidelia study.ICEF15, the most advanced candidate in the company group's pipeline, aims to provide a fundamental treatment for urge fecal incontinence by locally administering the patient's own skeletal muscle-derived cells into the external anal sphincter to promote muscle repair and regeneration. Fecal incontinence is defined as the involuntary leakage of stool from the anus, and it is said that approximately 5 million people in Japan suffer from this condition (Source: Website of the Japan Society of Coloproctology). According to a paper published in a specialized academic journal (Toshiki Aimura et al., "Investigation Report on the Actual Status of Fecal Incontinence Management in Japan - Current Status of Diagnosis and Treatment -" Journal of Japan Society of Coloproctology 65: 101-108, 2012), more than half (approximately 51%) of patients with fecal incontinence have urge symptoms. For patients with urge fecal incontinence who do not achieve sufficient improvement with conservative therapy (such as medication), surgical therapy (such as anal sphincteroplasty or sacral nerve stimulation) is applied. However, existing surgical therapies are considered to be highly invasive (burden on the patient's body) and may not always be sufficiently effective. ICEF15 has the potential to be a treatment option with lower invasiveness and potentially higher efficacy for patients who do not achieve adequate improvement with conservative therapy.The company group is currently conducting the Fidelia study, the final stage (Phase III) of ICEF15 clinical development, in 11 European countries and Japan. The Fidelia study is a multicenter, placebo-controlled, randomized, double-blind comparative study that will enroll a total of 290 patients, randomized 1:1 into two groups (investigational drug and placebo). The study aims to verify the efficacy and safety of ICEF15 by measuring the change in the frequency of fecal incontinence at 12 months post-administration compared to pre-administration as the primary endpoint. As of June 30, 2026, the number of patients enrolled in the Fidelia study (preliminary figures) is 250, representing approximately 86% of the planned enrollment of 290 patients.With the completion of the IND review by the FDA and the receipt of notification that the trial can commence in the United States, the Fidelia study can now be advanced as a global Phase III trial, including the world's largest pharmaceutical market, the United States. The company group is already preparing for the participation of multiple U.S. sites in the Fidelia study and plans to submit the additional documents requested by the FDA within the prescribed deadlines. At present, the company aims to complete the enrollment of all patients in the Fidelia study, including U.S. patients, by the end of 2026.This event represents an important development milestone in line with the global expansion plan for the Fidelia study that the company has previously announced.To the best of the company's knowledge, it is rare for a venture company to conduct a Phase III clinical trial involving a large number of patients independently. Furthermore, it is limited for a company to conduct a Phase III clinical trial independently targeting all major global markets, including the United States, Europe, and Japan. Since its founding, the company group has promoted global development and business expansion as a key strategy, and the realization of U.S. patient enrollment in the Fidelia study aligns with this policy.Reference InformationAn overview of the Fidelia study is also available on ClinicalTrials.gov.•NCT Number: NCT04976153•URL: https://clinicaltrials.gov/study/NCT04976153About Innovacell Inc. (https://innovacell.com/)The company's predecessor was a regenerative medicine company spun out from the Medical University of Innsbruck in Austria, Europe. The company was established in Japan in 2021 as the parent company of this Austrian company.The company group aims to improve people's health and quality of life through the commercialization of cell therapy and regenerative medicine. Currently, it is engaged in the research, development, and commercialization of regenerative medical products for the treatment of incontinence (urge fecal incontinence, passive fecal incontinence, stress urinary incontinence).ICEF15, the most advanced candidate in the company group's pipeline, is a product that aims to provide a fundamental treatment for urge fecal incontinence by utilizing the patient's own cells and promoting muscle repair and regeneration through local administration. The company group is currently conducting a Phase III international joint clinical trial for ICEF15 in 11 European countries and Japan.The company group has previously completed multiple clinical trials, including late-stage Phase II trials, for two pipeline products in Europe: ICEF15 (target: urge fecal incontinence) and ICES13 (target: stress urinary incontinence).