Citius Pharmaceuticals has revealed positive results from its Phase IIb Study of Halo-Lido (CITI-002) for the treatment of haemorrhoids.
The high dose formulation of CITI-002, a lidocaine and halobetasol combination formulation, provided a meaningful reduction in symptom severity, as reported by patients, when compared to individual components alone.
Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study.
The company has stated its intention to schedule an end of Phase II meeting with the US Food and Drug Administration (FDA) to begin planning the next steps in the regulatory and clinical development programme for CITI-002.
Following the 21st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (PRO) instruments in clinical trials. For the trial, Citius developed a PRO instrument to assess the efficacy of treatments in this disease.
Symptom intensity and impact data (Haemorrhoid Quality of Life Index or HQLI) were recorded by patients utilising a proprietary mobile-enabled PRO instrument. This data was analysed to derive a meaningful change threshold (MCT) to test for the change in haemorrhoidal symptoms considered relevant to the patient.
Advancement in haemorrhoid treatment
At the end of the seven-day treatment period, 42% of the patients in the high dose CITI-002 group reached MCT, compared to patients treated with high dose halobetasol alone (29%) or patients treated with lidocaine alone (21%).
Proportionally more patients in the CITI-002H cohort reported meaningful and statistically significant improvement as compared to patients treated with lidocaine alone.
“With its excellent safety profile and ease of administration for patients as a topical cream, we believe CITI-002 could be an important advancement in the treatment of haemorrhoids. Our preference is to seek a development partner to further advance CITI-002; we plan to initiate that process after determining our next steps in the development of CITI-002,” said Leonard Mazur, Chairman and CEO of Citius.
