Lupin Pharma Announces Phase 3 Trial Success of Solosec (Secnidazole) for Trichomoniasis in Women with Over 90% Cure Rate

August 15, 2020 /BioValleyBIOON/ -- Lupin Pharma recently announced the results of a pivotal Phase III trial evaluating a single 2-gram oral granule dose of Solosec (secnidazole) for the treatment of trichomoniasis in female patients.Clinical Trialresults. Trichomoniasis is the most common non-viral, curable sexually transmitted infection (STI) in the United States. Trial results demonstrated that the Solosec treatment group showed a clinically and statistically significant improvement in cure rates compared to the placebo group, orMicrobiological cure rate (92.2% vs 1.5%; p < 0.001).These data were presented at the 47th Annual Meeting of the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) in 2020.

Solosec 2 g Oral Granules is a 5-nitroimidazole antibacterial agent., currently only in the United StatesFDAApproved for the treatment of adult womenBacteriaBacterial vaginosis (BV). The drug is aSingle-Dose Oral Therapy, The entire contents of the Solosec packet should be sprinkled on applesauce, yogurt, or pudding and consumed within 30 minutes without chewing or crushing the granules. Solosec should not be dissolved in any liquid.

Based on these data, Lupin will submit to the United States later this yearFDASubmit a supplemental New Drug Application (sNDA) for Solosec in the treatment of trichomoniasis.Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the United States., is caused by a protozoan parasite called Trichomonas vaginalis. It is estimated that 3 to 5 million people in the United States are infected. Trichomoniasis is associated with a 2- to 3-fold increased risk of HIV infection and is linked to adverseReproductive Healthassociated with outcomes (including infertility and preterm birth).

Trichomonas vaginalis (Image source: avert.org)

This publication reports a multicenter, randomized, delayed-treatment, placebo-controlled, double-blind Phase III study that enrolled 147 adult female patients to evaluate the efficacy and safety of a single oral dose of Solosec granules for the treatment of trichomoniasis. Study participants were at the screening visit (Visit 1, first visit, baseline assessment)DiagnosisFor trichomoniasis, with a positive culture for Trichomonas vaginalis. At Visit 1, subjects were randomized in a 1:1 ratio to receive Solosec or matched placebo. At Visit 2 (Days 6–12), subjects underwent a test-of-cure (TOC) assessment; at this time (after sample collection for TOC culture), subjects who had received placebo at baseline were treated with Solosec, while those who had received Solosec at baseline were treated with placebo. Subjects were then followed up to determine resolution of trichomoniasis and the need for additional treatment.

The primary endpoint of this study was the proportion of patients achieving microbiological cure at the Test-of-Cure (TOC) visit. Microbiological cure was defined as a negative Trichomonas vaginalis culture (e.g., a negative inPouch TV test for T. vaginalis) in the modified intent-to-treat (mITT) population, which comprised all randomized subjects who were culture-positive for T. vaginalis and negative for Neisseria gonorrhoeae and Chlamydia trachomatis at baseline.

The results showed that the study met its primary endpoint: inIn the mITT population, at the TOC visit, 92.2% of patients (59/64) in the Solosec group achieved microbiological cure, compared with 1.5% (1/67) in the placebo group (p<0.001).. In the per-protocol population,In the PPP population, the cure rate for Solosec was 94.9% (56/59), compared with 1.7% (1/60) for placebo (p<0.001).. Solosec was well tolerated. The most commonAdverse Reactionswere vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed during the trial.

IDSOGConference“The efficacy results from the Phase III study are highly encouraging and, pending approval of the new indication, can support the use of Solosec as a treatment for trichomoniasis in clinical practice,” said Dr. Christina Muzny, Professor of Medicine at the University of Alabama at Birmingham. “Trichomoniasis increases the risk of HIV infection, disproportionately affects African American women, and may lead to adverse health outcomes. Screening high-risk women and treating them with a convenient therapy is critical to improving patient adherence.”

Dr. Gregory Kaufman, Senior Vice President of Global Clinical and Medical Affairs at Lupin, stated, “Trichomoniasis is the most common non-viral sexually transmitted infection, affecting an estimated 3 to 5 million people in the United States. We look forward to working withFDAcooperation.” (Bioon.com)

Original Source: Lupin Presents Phase 3 Data for Solosec® (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis