Citius Pharmaceuticals has submitted paperwork for patent applications on the formulations for Halo-Lido (CITI-002) haemorrhoid cream after reviewing the results of a Phase IIb trial.
The study involving 300 patients across five treatment groups was designed to assess the efficacy, appropriate dose, and endpoints of CITI-002, as well as validate the patient-reported outcome (PRO).
CITI-002 is a lidocaine and halobetasol propionate combination topical formulation administered twice daily for seven days for haemorrhoid relief. Although completed, the US Food and Drug Administration (FDA) is yet to receive the results.
The multi-centre, randomised, dose-ranging, double-blind, parallel-group comparison clinical trial study assessed a high dose (CITI-002H) and low dose (CITI-002L) in comparison to the single active drug monads of high-dose halobetasol, low-dose halobetasol, and lidocaine.
Data was reported using the Haemorrhoid Quality of Life Index (HQLI) and analysed to derive a meaningful change threshold (MCT) from testing the change in hemorrhoidal symptoms, including pain, burning, itching, and swelling.
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Results of the Phase IIb trial
At the end of the seven-day treatment period, 42% of the patients in the CITI-002H group reached MCT. This was compared to 29% of patients treated with high-dose halobetasol alone and 21% of patients treated with lidocaine alone.
Proportionally, more patients in the CITI-002H cohort reported meaningful and statistically significant improvement compared to patients treated with lidocaine alone (p = 0.035).
Clinical treatment efficacy outcomes were also assessed during the seven-day treatment and seven-day follow-up periods, showing improvements across all active treatment groups. No statistical significance was determined in the changes between the comparison groups.
Citius has reported that directionally, the data signalled that the combination products provided faster relief compared to individual monads, which persisted after completing treatment. No clinical safety concerns or serious adverse events were reported during the seven-day treatment or follow-up periods.
Citius’ plans for CITI-002
Citius chief medical officer Dr Myron Czuczman said: “The encouraging Phase 2b results indicate that CITI-002 may have the potential to provide patients with relief from the pain and discomfort associated with haemorrhoids. We now better understand how to design the pivotal Phase III study with relevant endpoints and look forward to further use of our proprietary PRO tool to evaluate efficacy.”
Following the filed patent applications, Citius plans to schedule an end-of-Phase II meeting with the FDA to plan the next steps in the regulatory and clinical development programme as the company prepares for a Phase III trial.