Source: Citius Pharmaceuticals, Inc. 4/26/2022
Primary endpoint is the reduction in hemorrhoidal symptoms
Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the first patient has been enrolled in the Company's Phase 2b clinical study of Halo-Lido for the treatment of hemorrhoids. If approved, Halo-Lido would be the first FDA-approved prescription product indicated for the treatment of hemorrhoids.
The Phase 2b study is a multi-center, randomized, dose-ranging, double-blind, parallel group comparison clinical trial. Five cohorts of adults with a clinical diagnosis of symptomatic Goligher's classification Grade II or Grade III hemorrhoids will be dosed. Approximately 60 patients per cohort are expected to be enrolled, for a total of 300 patients.
The key objective of the study is to evaluate the ability of the formulations used in each cohort to provide relief for patients with acute flare ups. The study will evaluate reduction in hemorrhoidal symptoms (including: pain, burning, itching, and swelling) following treatment and is expected to provide the foundation for development of the Phase 3 study. The FDA has guided Citius in developing a Patient Reported Outcome (ePRO) instrument which patients will use to record and report important safety and efficacy data in real time. The instrument has been adapted for use on an electronic platform and will be loaded on patients' hand-held smart devices. The study will also be used to validate the ePRO. Results of this trial are expected in the second half of 2023.
"We are pleased to have initiated the Halo-Lido study and expect to complete enrollment later this year. Currently, there are no FDA-approved prescription-strength treatments available to the millions of adults who suffer from hemorrhoid discomfort each year. If approved, Halo-Lido would be the first prescription product indicated for the treatment of hemorrhoids. As such, we believe there is a substantial worldwide market opportunity for this drug candidate. Assuming study results are positive, and in order to realize the full potential of Halo-Lido, we intend to seek strategic or financial partners for this asset at the appropriate time," stated Leonard Mazur, Executive Chairman of Citius.
About Halo-Lido
Halo-Lido is a proprietary topical formulation of halobetasol and lidocaine that is 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 has two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), 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 cutaneous T-cell lymphoma (CTCL), which has completed enrollment in its Pivotal Phase 3 trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Through its subsidiary, NoveCite, Inc., Citius is developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS) associated with COVID-19.
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