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S1 Biopharma Aims for Female Viagra for HSDD Sans Hormones

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By Lynn Yoffee
Executive Editor

When Nick Sitchon set out to identify a first product for his start-up, S1 Biopharma Inc., the medical school dropout turned entrepreneur chatted with his mother and hit (potential) pay dirt with her very first idea: "Why not develop something for me and my low libido?"

Giggles aside, Sitchon knew immediately the market would be huge if his company could ace the challenging indication presented by millions of women who, for reasons of age or other conditions, have a persistent lack of sexual desire, known as hypoactive sexual desire disorder (HSDD) and symptoms of generalized female sexual dysfunction (FSD).

"I joke about my mom, but as I dug, I discovered that 26 million women suffer from HSDD; that's one in 10 women in the U.S. It's the same in Western Europe," Sitchon told BioWorld Today at the recent J.P. Morgan Healthcare Conference in San Francisco.

Sitchon and his team have been in stealth mode since S1 Biopharma's inception in 2011. But they were on the prowl at J.P. Morgan and reported that reception to the idea was positive. Though most other biopharmas are developing therapeutics for serious life and death diseases, S1's focus is on quality of life. Needless to say, business cards were exchanged with potential investors as well as "tire kickers asking for samples," Sitchon said.

Other than hormone therapy – which to date has yielded less-than-stellar results in treating HSDD and comes with myriad side effects and health risks – there is no pharmacological treatment for HSDD or FSD.

Current treatment options are limited to psychological therapy, investigation of potential underlying medical conditions or medication adjustments if a patient is taking a drug for another condition which may inhibit sexual desire.

But none of those options address true HSDD, said S1's chief medical officer, Robert Pyke, former director of clinical research at Boehringer Ingelheim GmbH, where he led the Flibanserin Worldwide premenopausal HSDD clinical program that ended in October 2010. Pyke also hails from Parke-Davis and Bristol-Myers Squibb Co. where he worked on various central nervous system (CNS) drugs related to anxiety, depression and substance abuse to name a few. Those stints combined, led Pyke to investigate a CNS therapeutic route to treat HSDD.

It started when Boehringer Ingelheim hired him in 1996 to help develop an antidepressant that was, surprisingly, not neutral to sexual effects. From 2002-2010, he then led the HSDD project deepening his knowledge of the condition.

Sitchon and Pyke's early collaboration, along with input from S1 Biopharma's scientific board member Robert Taylor Segraves eventually led to Lorexys.

Segraves is a professor of psychiatry at Case Western Reserve School of Medicine who has authored more than 200 articles on human sexuality and sits on the editorial board of the International Journal of Impotence Research and is the current editor of the Journal of Sex and Marital Therapy.

After testing multiple antidepressant combinations, the team hit one that impressed not only the officers at S1 Biopharma enough to seek funding from friends and family – but also raised eyebrows at the FDA.

S1 Biopharma last year presented data from a single-patient pilot study of Lorexys (a name derived partly from orgasm and ecstasy), which apparently was so impressive that the agency permitted the biopharma to jump straight into efficacy evaluation with a Phase II trial.

Lorexys (aka SIP-104) combines two yet-to-be disclosed FDA-approved antidepressants with the slow-release element unleashed. The instant-release formulation is part of the secret sauce that clicked.

Sitchon declined to reveal the two antidepressants until required, which is when the Phase IIa begins. An investigational new drug application (IND) was filed in early 2012 and that Phase IIa is set to begin in four to six weeks; data readout is expected around July.

Study 1000 is being conducted in 30 premenopausal women with HSDD. They're being treated for four weeks with each of two doses of Lorexys with washouts between the treatments.

A Phase IIb is planned to be completed by the summer of 2014. Assuming positive outcomes, three Phase III trials with 900 patients will occur in 2014-2015, leading to a new drug application filing as early as 2016. The Phase IIa is expected to last four to six weeks, Phase IIb eight weeks and the Phase III, 24 weeks.

Pyke said the single patient in the pilot study reported an improved libido within just one week.

In tandem, the firm's chief financial officer, John Kaufmann, said S1 Biopharma expects its first large-scale institutional investment round this summer. The J.P. Morgan meeting was stomping grounds to establish those relationships.

Though the label "female Viagra" was volleyed back and forth by S1's execs, Pyke pointed out that Lorexys is truly different from Viagra because it's a CNS drug. Whereas the Viagra market focuses on erectile dysfunction (ED), woman's libido problems are not vascular by nature. Even women who have other health problems such as cancer, irritable bowel syndrome, diabetes or migraines may have reduced libido due to the ravages of their disease or medications. And then there are all of those pre- and post-menopausal women with reduced sex drives who decline to take hormones. . . .

Not Just for Women

S1 Biopharma isn't stopping with women. Though many men have ED, there's a whole other market of men who simply have lost their sexual desires. "If you don't have desire you don't get an erection," Pyke said. "And men seem to be more miserable or worse with this than women."

So, right behind Lorexys for women in S1's pipeline is S1P-205 for men, still in the pre-IND stage. But the therapeutic goals and approaches are the same: "There is dual control model of sex dysfunction in the brain. Serotonin is a signal for sex dysfunction. But you can't just block serotonin or just give testosterone, you should block the negative and stimulate the positive and that's what Lorexys does," Pyke said.

The company is ultimately banking that the once-a-day pill works for both sexes. Combining both markets translates to 100 million potential patients worldwide and a $6 billion blockbuster target for S1 Biopharma – if Lorexys hits.

Currently virtual, Sitchon plans to open an office for S1 Biopharma in midtown Manhattan within a year and anticipates a lean staff of 15.

Even though he thinks he's got an ace with Lorexys, Sitchon said he isn't interested in just licensing away the rights to the potential female Viagra.

"I want to build the best possible company, and I want it to be fun," Sitchon said.

With that kind of drug in the hopper, Sitchon and team are bound to have a company full of happy campers.