Citius Pharma completes Final Patient In phase 2b study of Halo-Lido for prescription treatment of Haemorrhoids

Citius Pharmaceuticals, Inc., a late-stage biopharmaceutical company, announced that the final patient in the company's phase 2b clinical study of Halo-Lido (CITI-002), a topical formulation for the relief of haemorrhoids, has been enrolled. If approved by the US Food and Drug Administration, CITI-002 would be the first prescription product indicated for the treatment of haemorrhoids (FDA). The Halo-Lido Phase 2b study (NCT05348200), a multi-center, randomised, dose-ranging, double-blind, parallel group comparison clinical trial, enrolled approximately 300 adults with a clinical diagnosis of symptomatic haemorrhoids.

The primary outcome of the study is the improvement in haemorrhoidal symptoms reported by patients after treatment. Patients record efficacy and safety data using a proprietary mobile-enabled Patient Reported Outcome (ePRO) instrument. The study's findings are expected by the end of the second quarter of 2023, and they will serve as the foundation for the development of the phase 3 study. "Citius has reached an important milestone with the completion of phase 2b enrollment. We are hopeful that further evaluation of the potential of CITI-002 to provide relief for haemorrhoid patients will be aided by the analysis of the study data. We congratulate our clinical management team, CRO staff, and principal investigators for assisting us in meeting this milestone on time.

The study was completed within a year of its inception. We continue to believe that there is a large and underserved global market for a prescription topical treatment for haemorrhoids. Depending on the trial results, we expect to continue to advance this programme in order to maximise its value "Citius executive chairman Leonard Mazur stated. CITI-002 is a proprietary topical formulation designed to provide symptomatic relief to people who have haemorrhoids. Haemorrhoids are a digestive disorder that causes pain, swelling, itching, tenderness, and bleeding.

Although haemorrhoids are not fatal, individual patients frequently experience painful symptoms that limit social activities and have a negative impact on quality of life. More than half of the people in the United States will develop haemorrhoidal disease at some point in their lives. Approximately 10 million patients in the United States report symptoms each year. 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.