S1 Biopharma supports FDA's approval of flibanserin for women living with HSDD

S1 Biopharma is a developer of first-in-class drugs for sexual dysfunction in both women and men. The company's lead compound, Lorexys, is currently in Phase IIb for the treatment of hypoactive sexual desire disorder (HSDD).

Tuesday's approval of flibanserin by the U.S. Food and Drug Administration (FDA) was a significant advancement for women's health, addressing the important unmet medical need for women living with HSDD. The condition is marked by a lack of sexual thoughts and desire for sexual activity that cannot be accounted for by another medical, physical, psychiatric, or medication-induced condition. An estimated one in 10 women may have HSDD at some point in their life, for which therapies like flibanserin and Lorexys, S1 Biopharma's next-generation first in class drug, are being developed to address.

We are pleased for Dr. Robert Pyke, who before joining S1 Biopharma as Chief Medical Officer in 2012 to develop Lorexys, had fathered flibanserin at Boehringer Ingelheim before it was acquired by Sprout Pharmaceuticals.

S1 Biopharma, Inc. is continuing the development of Lorexys, a unique multi-receptor oral tablet being studied for the treatment of HSDD in pre-menopausal women. Lorexys will provide first-line treatment for women suffering from HSDD as an easy to administer daily pill.

With a novel mechanism, which modulates pathways in the brain already proven to be involved in sexual response, Lorexys is designed to help a majority of patients achieve meaningful response. In its Phase IIa study, 76% of women responded to Lorexys, a 38% improvement over active control. Unlike flibanserin, with a 9%- 13% responder rate over placebo, or other FSD treatments in development, Lorexys appears to help a large majority of patients achieve meaningful response. This meaningful response has a wide margin of efficacy over control treatment and restores women's sexual desire rather than serve as a mild aid. Also important, the proprietary ratio of ingredients in Lorexys has helped women achieve remission rapidly, in a month or less. In contrast to other treatments, in its Phase IIa studies Lorexys was not associated with dropouts related to drowsiness, dizziness or nausea. Lorexys is planned to be the most personalized treatment available. To optimize dosage for every woman, more than one strength is available. It can also be taken in combination with social alcohol consumption or other medications. Lorexys is expected to be an effective and broadly applicable treatment option among those women suffering from HSDD.

S1 Biopharma looks forward to upcoming clinical trials expected to bring Lorexys closer to approval as a treatment for HSDD, expanding the HSDD marketplace. This coming year, S1 Biopharma expects to start enrolling pre-menopausal women with HSDD in Phase IIb trials for Lorexys. Each of the eight-week parallel-group trials will be multicenter, randomized, and placebo controlled. An open-label extension study is anticipated for those who complete treatment in the parent trial. The clinical trials are designed to randomize a total of at least 300 women to evaluate the efficacy and safety of Lorexys in premenopausal women with HSDD.