IPM Initiates First Trial of Novel HIV Prevention Drug for Women

Study in Belgium evaluates safety and tolerability of novel ARV-based women’s health technology

SILVER SPRING, Md. (November 3, 2015) – The nonprofit International Partnership for Microbicides (IPM) today announced the initiation in Belgium of the first clinical trial to test a vaginal microbicide containing DS003, a novel antiretroviral drug (ARV), for the prevention of sexual transmission of HIV in women. The results of the trial, which is known as IPM 042, will inform the development of future DS003-based products, such as a long-acting vaginal ring.

DS003 is a novel gp120 binding inhibitor that acts early in the HIV life cycle, blocking the virus’s ability to enter a healthy cell. Because drugs with this mechanism of action are not currently approved for HIV treatment or prevention, DS003 has significant potential to prevent infection of drug-resistant HIV. IPM, which developed the tablet and is leading the trial, negotiated a royalty-free license for DS003 with Bristol-Myers Squibb in 2005. 

“DS003 is a potent new ARV that opens up new opportunities in HIV prevention research,” said Dr. Zeda Rosenberg, chief executive officer of IPM. “This study broadens IPM’s portfolio and moves the field one step closer to offering women a range of potential products they can use to protect their sexual and reproductive health.”

The product being tested in IPM 042 is a vaginal tablet whose small size could be an advantage in settings with limited storage capacity. Once in place, the tablet breaks down to release DS003. Vaginal tablets containing tenofovir and emtricitabine have also been studied in an early-stage clinical trial.

Importantly, IPM is exploring the development of other DS003-based products, including vaginal rings with DS003 alone and in combination with ARVs in different classes, such as dapivirine, a non-nucleoside reverse transcriptase inhibitor that prevents HIV from replicating after entering a healthy cell. By attacking HIV at different points in its life cycle, such combination products may offer greater protection against the virus over time. In addition, vaginal rings can slowly release the active drugs over a month or longer, potentially leading to greater ease-of-use.

About IPM 042

IPM 042 is a double-blinded Phase I trial that will determine the safety and tolerability of three doses of the DS003 vaginal tablet. This is the first time that DS003 is being studied in humans following the completion of preclinical safety assessments. Thirty-six healthy women volunteers in Belgium will be assigned to study groups in three stages. The first group of 12 volunteers will be randomly assigned to use either a 1 mg DS003 or placebo tablet. Once researchers deem that the safety of this dose is satisfactory, the next group of 12 volunteers will be randomly assigned to receive either a 3 mg DS003 or placebo tablet. Once safety of this dose is deemed satisfactory, the third group of 12 volunteers will be randomly assigned to either a 10 mg DS003 or placebo tablet. For every three women who receive a DS003 tablet, one receives a placebo tablet.

All women participating in the study will receive testing and counseling to reduce their risk of acquiring HIV and other STIs, including the provision of condoms, as well as contraception adherence counseling and other health services. The trial is expected to be completed in late 2016.

Need for New HIV Prevention Technologies for Women

Despite progress in reducing new HIV infections worldwide, women and girls continue to bear a disproportionate burden of the HIV/AIDS epidemic. In sub-Saharan Africa, young women and adolescent girls ages 15 to 24 are at least twice as likely to be infected as their male counterparts.  

“To overcome the epidemic, women need product options they can use to keep HIV at bay and take control of their own health,” said Dr. Annalene Nel, chief medical officer of IPM. “New female-initiated tools, including microbicides and multipurpose prevention technologies, are especially needed in regions such as sub-Saharan Africa, where HIV is taking its highest toll on women and girls.”

New tools such as microbicides are being developed because stopping HIV’s spread among women requires a range of options that meet their individual needs. The only microbicide now in late-stage trials is the dapivirine vaginal ring, which is designed to provide sustained protection against HIV over the course of a month. The first efficacy results for the ring, developed by IPM, are expected in early 2016.

Since 2004, five major pharmaceutical companies — Bristol-Myers Squibb, Gilead, Janssen, Merck & Co., and ViiV Healthcare — have entered into royalty-free licenses with IPM to develop, manufacture and distribute eight ARVs as microbicides in developing countries. These licenses ensure that any new product will be provided at low cost in the settings where it is most urgently needed.  

This trial is made possible through generous support from the American people through the United States Agency for International Development (USAID) through the President’s Emergency Plan for AIDS Relief (PEPFAR).

About IPM: 

IPM is a nonprofit organization dedicated to developing new HIV prevention tools and other sexual and reproductive health technologies for women, and making them available in developing countries. IPM has offices in the United States and South Africa. Please visit www.IPMglobal.org. 

Contacts:

IPM US and Europe: Holly Seltzer, hseltzer@IPMglobal.org, +1.301.608.4277

IPM Africa: Leonard Solai, lsolai@IPMglobal.org, +27.21.860.2314