13 May Trichomoniasis: Results of Phase 3 Trial to Assess Efficacy and Safety of Single-Dose Solosec® (secnidazole) in Women
MedicalResearch.com Interview with:
Gregory Kaufman, M.D.
Senior Vice President
Global Clinical and Medical Affairs
Specialty at Lupin
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by trichomoniasis? How common is this infection?
Response: The Phase 3 trial evaluated the effectiveness and safety of a single oral dose of Solosec® (secnidazole) 2g oral granules for the treatment of trichomoniasis in adult women. Top-line results were positive and showed that Solosec was generally well-tolerated.
Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the U.S., and is caused by a protozoan parasite called Trichomonas vaginalis.[i] Trichomoniasis affects 3 to 5 million people in the U.S.,[ii] and is four- to five-times more prevalent in in women, compared to men.[iii].
MedicalResearch.com: What are the main findings?
- Lupin announced positive top-line results from its pivotal Phase 3 clinical trial to assess efficacy and safety of single-dose Solosec® (secnidazole) 2g oral granules in 147 female patients with trichomoniasis, a common sexually transmitted infection (STI)
- The trial met its primary endpoint of microbiological cure at the test-of-cure (TOC) visit on study Day 6-12, defined as a negative Trichomonas vaginalis (T. vaginalis) culture
- The predefined primary efficacy endpoint, defined as Microbiological Cure (i.e., InPouch™ TV test negative for T. vaginalis) at the TOC visit (Day 6-12) in the modified Intent-To-Treat (mITT) population (all randomized subjects who were culture positive for T. vaginalis and negative for gonorrhea and chlamydia at baseline), was 92.2% (59/64) for Solosec versus 1.5% (1/67) for placebo (p<0.001)
- In the Per-Protocol population, the cure rate was 94.9% (56/59) for Solosec versus 1.7% (1/60) for placebo (p<0.001)
- Solosec was generally well-tolerated with the most commonly reported adverse events being vulvovaginal candidiasis (2.7%) and nausea (2.7%). No serious adverse events were observed.
- The American College of Gynecology (ACOG) currently recommends a twice-daily for seven day treatment or alternatively a single-dose treatment.ii However, trials have shown 7-day regimens to be more effective, with higher cure rates.[iv] In addition, in real-world settings, treatment failures and reinfection rates are high, and medication non-compliance is a common cause.iv
MedicalResearch.com: How does Solosec® differ from other treatments for this disorder?
Response: Solosec is currently approved by the U.S. FDA to treat bacterial vaginosis in adult women.[v] It has not been evaluated by the FDA for the treatment of Trichomoniasis. The company plans to submit a supplemental New Drug Application (sNDA) to the FDA in 2H2020 for review.
MedicalResearch.com: What should readers take away from your report?
Response: We are encouraged by the top-line findings from the Phase 3 study and plan to submit the full results for presentation at an upcoming medical meeting. Based on the full analysis, we plan to submit for evaluation, a supplemental New Drug Application to the FDA in the second half of this year for Solosec to treat trichomoniasis with a single dose.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Additional information on the disparities regarding the increased risk of contracting trichomoniasis among certain populations would further help us understand the disease. For example, African American women have a nearly ten times higher risk of being affected compared with non-Hispanic white women.iii Trichomoniasis is four- to five-times more prevalent in women compared to men.iii In addition, trichomoniasis can increase the risk of contracting or spreading other sexually transmitted infections and it is associated with a two- to three-fold increased risk of HIV infection. [vi],[vii] Trichomoniasis is also associated with adverse reproductive health outcomes, including infertility and preterm birth.iv
MedicalResearch.com: Is there anything else you would like to add?
Response: Lupin is committed to developing treatments for conditions like trichomoniasis, which impact millions of women and we are encouraged by the top-line findings from the Phase 3 study.
[i] Centers for Disease Control and Prevention. Trichomoniasis – CDC Fact Sheet. Available at: https://www.cdc.gov/std/trichomonas/stdfact-trichomoniasis.htm. Accessed April 21, 2020.
[ii] American College of Obstetricians and Gynecologists. Vaginitis in Nonpregnant Patients. ACOG Practice Bulletin No. 215. Obstet Gynecol 2020;135(1):e1-17.
[iii] Flagg EW, Meites E, Phillips C, Papp J, Torrone EA. Prevalence of Trichomonas vaginalis Among Civilian, Noninstitutionalized Male and Female Population Aged 14 to 59 Years: United States, 2013 to 2016. Sex Transm Dis. 2019;46(10): e93–e96. doi:10.1097/OLQ.0000000000001013.
[iv] Sobel JD, Mitchell C. Trichomoniasis. UpToDate. Available at: https://www.uptodate.com/contents/trichomoniasis. Accessed April 22, 2020.
[v] SOLOSEC [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals, Inc; 2019.
[vi] McClelland, RS. Infection with Trichomonas vaginalis increases the risk of HIV-1 acquisition. Journal of Infectious Diseases. 2007 Mar 1;195(5):698-702.
[vii] Van Der Pol, B. Trichomonas vaginalis infection and human immunodeficiency virus acquisition in African women. Journal of Infectious Diseases. 2008 Feb;197(4):548-54.
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