How 1 Drug, 2 Trials, And 2 CROs Might Transform Birth Control

By Ed Miseta, Chief Editor, Clinical Leader

On World Contraception Day (September 26) Evofem Biosciences announced results from its commissioned consumer survey conducted by The Harris Poll, which aligns with previously published data by the Guttmacher Institute. Results indicate that 24 million¹ sexually active American women (55 percent) currently use no birth control method, yet these women have an 85 percent risk of becoming pregnant within one year². Additionally, of those American women who use birth control, about 8 million¹ (36 percent) would prefer non-hormonal birth control.

That last fact is good news for Evofem considering the company’s product candidate, Amphora, is being positioned as the first and only, woman-controlled “only when she needs it” birth control product with no hormones and no systemic side-effects. “We believe it will be the first birth control product approved by the FDA that also will work to prevent recurrent chlamydia,” explains CEO Saundra Pelletier.

Saundra Pelletier is familiar with the health issues facing women, as well as the products required to address their needs. In the last 20 years she has served as the VP of pharmaceuticals for Women First HealthCare; was the founding CEO for WCG, a non-profit organization helping women to access reproductive health products; and serves on the Board of Directors for Women Deliver, a global advocate for women’s health. Today, as the CEO of Evofem Biosciences, she is also navigating the clinical challenges involved in taking a women’s health product through to FDA approval.

According to a National Center for Health Statistics (NCHS) data brief, roughly 25 million women of reproductive age in the U.S. are not currently using prescription birth control. Roughly 16.5 million of those women use no contraceptive at all, while another 8.5 million use a barrier method or some other form of alternative birth control.

But contraception is only half the problem. For women who are sexually active, prevention of sexually transmitted disease is also a concern. Pelletier notes there are 1.6 million new cases of chlamydia in the U.S. every year, a figure she calls “staggering.”  Evofem’s product, Amphora, is a Multipurpose Vaginal pH Regulator (MVP-R) that is a birth control method that will also prevent recurrent chlamydia infection. It does not contain hormones, using ingredients generally regarded as safe.

Two Trials and Two CROs

Headquartered in San Diego, California, Evofem Biosciences is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem has two large ongoing clinical trials for Amphora. One is a Phase 2b trial, AMPREVENCE, for use of the product in preventing recurrent chlamydia. The other is Phase 3 trial, AMPOWER, evaluating the use of Amphora for the prevention of pregnancy. Considering Evofem is a small company, the dual trials are certainly a challenge to manage. The Phase 3 trial is fully enrolled with approximately 1,400 patients at 112 sites, while the Phase 2b trial aims to recruit almost 850 participants.

While it might seem logical to use the same clinical research organizations (CRO) for both studies, Evofem has opted to work with two different partners. Also making this decision interesting is the fact that one CRO is a top five global service provider, while the other is a smaller, boutique company.

PAREXEL is the CRO that will be conducting the Phase 3 AMPOWER study, while Clinical RM (now ICON Government and Public Health Solutions [GPHS]) was selected to conduct the chlamydia study, also known as AMPREVENCE. Evofem conducted a thorough CRO selection process before landing on the partners that Pelletier felt would best conduct the trials.

“Clinical RM had experience in trials dealing with sexually transmitted diseases,” Pelletier says. “We engaged them on the smaller of the two studies, and they are a partner we felt could provide us the attention we desired. PAREXEL, on the other hand, has a long history of conducting contraceptive trials for companies both small and large. While we value the personal attention that can be provided by small- and mid-sized CROs, for the larger contraceptive study we felt they were the right partner for us.”

Size and Scope Are Important

Still, Pelletier notes Evofem is a small company. That means it does not have the purchasing power or financial backing of a Big Pharma firm like Pfizer or Merck. Evofem also does not have an additional 10 or 20 assets in its pipeline that could mean additional business for a CRO partner.   

“There is always a fear and trepidation when contracting with a large CRO,” says Pelletier. “The worry is you are not large enough to get the individualized attention you need, which could jeopardize the trial. In small companies, one trial will make or break you. Fail the first time and there is a good chance you will be out of business.”  

In the end, Evofem selected a large CRO because it had capabilities that smaller CROs did not possess. They could perform patient recruitment, medical writing, data analysis, and produce marketing messages for use on social media. Being a small company, it helped Evofem to have one partner that could perform all those tasks.

Sites Play a Key Role

Pelletier knows no trial can be successful without the support of qualified site personnel. A two-day investigator meeting is conducted for investigators, coordinators, and nurse practitioners. All aspects of the trial are covered at the meeting, and afterwards training is also available onsite and online.

Pelletier notes that training is also intense because there are many important details about the trial that site personnel need to be aware of. For example, for a woman to be admitted to the study, she must have a male partner, be engaging in sex at least three times per month, and is required to go through a “washout” period if she has previously taken a hormone product. Sites must also contact any trial participant who is not properly completing posting information to an electronic diary.

Giving thanks and appreciation always helps to develop better relationships. Although Pelletier expects a lot from these sites, she also lets them know she is thankful they have chosen to work on Evofem’s trial. She has heard sites complain that they never get a thank you from sponsors. For that reason, Pelletier will send each site a card during the holidays thanking them for their collaboration and reiterating how important their contributions are. The sites seem to appreciate her efforts. Pelletier gets many cards and messages from them as well, letting her know how professional and thoughtful her research managers are, and how the sites appreciate the personal interaction they have with the sponsor company.

Hire Knowledgeable Professionals

Evofem, currently has 38 employees. Although the company is growing, Pelletier is very careful when choosing new hires. She has met a lot of brilliant scientists in her career who are knowledgeable and experienced in developing innovative medicines. But for Pelletier, that is simply not enough. She believes to work on therapies in women’s health, scientists must have extensive experience in that area.   

“I look for individuals who have spent their careers working in women’s health,” she states. “I don’t care if someone is great at marketing, sales, or regulatory. I want people who understand the mindset of women, going from puberty clear through to menopause. It’s necessary to know when women want to get pregnant, when they don’t, what options are convenient, and more. You also have to understand the mindset of OBGYN’s, who care for women and write the majority of contraceptive prescriptions.” 

 “Although our team is small, it is highly skilled,” adds Pelletier. “They are skilled in women’s health and are passionate about the work they do. Everyone is emotionally invested in making sure this product makes it to market. More than 16 million sexually active women at risk of pregnancy have decided that they are not going to use a hormone-based contraception product. This is a huge unmet need, and we are determined to bring an effective product to that population, and to present an alternative to the millions of women using a prescription birth control method that is currently available.”

References

¹ Derived from NCHS Data Brief No. 173_December 2014 and the 2016 US Census Bureau data.

² Trussell J. Contraceptive Efficacy. In Hatcher RA, Trussell J, Nelson AL, Cates W, Kowal D, Policar M. Contraceptive Technology: Twentieth Revised Edition. New York NY: Ardent Media, 2011