Topline Results anticipated by the end of Q2 2023
Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR) today announced that the last patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of hemorrhoids. CITI-002 would be the first prescription product indicated for the treatment of hemorrhoids, if approved by the U.S. Food and Drug Administration (FDA).
Approximately 300 adults with a clinical diagnosis of symptomatic hemorrhoids were enrolled in the Halo-Lido Phase 2b study (NCT05348200), a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. The primary outcome of the study is the change in hemorrhoidal symptoms as reported by the patients following treatment. Efficacy and safety data are recorded by patients utilizing a proprietary mobile-enabled Patient Reported Outcome (ePRO) instrument. The results of the study are anticipated by the end of the second quarter of 2023 and are expected to provide the foundation for development of the Phase 3 study.
"The completion of the Phase 2b enrollment is an important milestone for Citius. We are hopeful that analysis of the study data will support further evaluation of the potential of CITI-002 to provide relief for hemorrhoid patients. We congratulate our clinical management team, our CRO staff and the principal investigators who helped us achieve this milestone in a timely fashion. The study was fully enrolled within one year from initiation. We continue to believe that the global market for a prescription topical treatment for hemorrhoids is large and underserved. Contingent on the trial data, we expect to continue to advance this program to maximize its value," stated Leonard Mazur, Executive Chairman of Citius.
About Halo-Lido (CITI-002)
CITI-002 is a proprietary topical formulation intended to provide symptomatic relief to individuals suffering from hemorrhoids. Hemorrhoids are a gastrointestinal disorder characterized by pain, swelling, itching, tenderness, and bleeding. Although hemorrhoids are not life-threatening, individual patients often suffer painful symptoms that can limit social activities and have a negative impact on the quality of life. More than half of the U.S. population will experience hemorrhoidal disease at least once in their life. Each year, nearly 10 million patients in the U.S. report symptoms.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in CTCL, for which a BLA is under review by the FDA. Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and PTCL. At the end of March 2023, Citius completed enrollment in its Phase 2b trial of CITI-002, a topical formulation for the relief of hemorrhoids.
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