Date: 05-May-2020

Lupin Announces Positive Top-line Results From Phase 3 Study Of Single-dose Solosec To Treat Trichomoniasis

Lupin Pharmaceuticals Inc. (Lupin), the US based wholly owned subsidiary of Lupin Limited, 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. Trichomoniasis is the most common non-viral, curable, sexually transmitted infection (STI) in the US. The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec as compared to placebo (p<0.001).

Based on the data, Lupin plans to submit a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Solosec for the treatment of trichomoniasis in the second half of 2020. Solosec is approved by the US FDA to treat bacterial vaginosis (BV) in adult women.

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 culture. The predefined primary efficacy endpoint, defined as Microbiological Cure (i.e., InPouch TV test negative for T. vaginalis) at the Test-Of-Cure 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 (secnidazole) 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 (secnidazole) versus 1.7 % (1/60) for placebo (p<0.001). Solosec (secnidazole) 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.

“Trichomoniasis impacts an estimated 3 to 5 million people in the US,” Gregory Kaufman, M.D., senior vice president, global clinical and medical affairs, specialty at Lupin said. “We are encouraged by the topline results of our clinical trial, look forward to finalizing the analysis, and working with the FDA to provide a new single-dose therapy option to physicians and patients, to treat this disease.”

The phase 3 trial is a multicenter, randomized, delayed treatment, placebo-controlled, double-blind study to evaluate the effectiveness and safety of a single oral dose of Solosec (secnidazole) granules for the treatment of trichomoniasis in adult women. Subjects included female patients with a diagnosis of trichomoniasis at the screening visit (Visit 1, baseline) that was confirmed by a positive culture for T. vaginalis. At Visit 1, subjects were randomly assigned in a 1:1 ratio to either Solosec or matching placebo. Subjects were evaluated for TOC at the second visit (Visit 2, Day 6 -12), at which (following sampling for the TOC culture), subjects also received active treatment if they had received placebo at baseline, and subjects received placebo if they had received active treatment at baseline. Subjects were then followed at subsequent visits for resolution of trichomoniasis as well as any need for additional therapy.

Trichomoniasis is the most common non-viral sexually transmitted infection (STI) in the US, and is caused by a protozoan parasite called Trichomonas vaginalis. An estimated 3 to 5 million people have the infection, with African American women having a nearly ten times higher risk of being affected compared with non-Hispanic white women. Trichomoniasis is four-to-five times more prevalent in women compared to men. Signs and symptoms in women can include itching, burning, redness or soreness of the genitals, discomfort with urination and vaginal discharge. However, most infected persons (70%-85%) have minimal or no symptoms, and untreated infections might last for months to year. Trichomoniasis is associated with a two- to three-fold increased risk of HIV infection, as well as adverse reproductive health outcomes, including infertility and preterm birth. Up to 53% of women with HIV infection also have T. vaginalis, which is associated with a significantly increased risk of contracting pelvic inflammatory disease (PID). Routine screening of asymptomatic women with HIV infection for T. vaginalis is recommended because of the adverse events associated with asymptomatic trichomoniasis and HIV infection. Patients receiving care in high-prevalence settings (e.g. STD clinics) and asymptomatic patients at high risk for infection (e.g., persons with multiple sex partners, history of STDs) may also be considered for screening.

Solosec (secnidazole) 2g oral granules is the first and only single-dose oral prescription treatment option to treat bacterial vaginosis (BV), a common vaginal infection, in adult women. Solosec is easy to take, and one oral dose contains a full course of treatment. Women who are prescribed Solosec sprinkle the entire packet of granules onto applesauce, yogurt, or pudding and eat the entire mixture without chewing the granules within 30 minutes. One dose delivers a complete treatment and Solosec can be taken at any time of day, without regard to the timing of meals. There is no need to avoid any foods or drinks, including alcohol, with Solosec. Laboratory studies show Solosec does not inhibit the enzyme that processes alcohol in the body. Because Solosec is taken in one oral dose, it may be preferred by women who wish to avoid a multi-day treatment regimen.

Solosec (secnidazole) 2 g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women.

Solosec is a single-dose therapy for oral use. The entire contents of Solosec packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. Solosec is not intended to be dissolved in any liquid