MB66 FAQ

MB66 is a multipurpose prevention technology intended to block sexual transmission of genital herpes and HIV.

What is MB66?

MB66 is a multipurpose prevention technology intended to block sexual transmission of genital herpes and HIV. It is a film, that, when applied to the vagina, rapidly dissolves and releases antiviral antibodies to the vaginal mucosa. Those antibodies prevent against transmission of genital herpes and HIV.

What is a multipurpose prevention technology?

Multipurpose prevention technologies (MPTs) are a new class of product in development that work to simultaneously prevent HIV, sexually transmitted infections and unplanned pregnancies. There are many innovative MPTs in development that work in different ways and MB66 is one of them. Some combine contraception with STI prevention, while others provide women who want to get pregnant with protection from HIV and other STIs. For additional information, visit the Initiative for Multipurpose Prevention Technologies.

Who developed MB66? Did Mapp have partners?

MB66 is being developed exclusively by Mapp Biopharmaceutical and has been in development since 2003. It is being evaluated for safety and efficacy by a consortium of investigators from Boston University, Johns Hopkins University, University of North Carolina, Emory University, Brown University, Harvard University, Fenway Health, Oak Crest, Aridis Pharmaceuticals, Kentucky BioProcessing and Mapp.

Where did the funding for the development of MB66 come from?

The consortium of investigators are funded by a grant from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. Mapp has been working to develop this MPT for over a decade with the support of many partners.

Does MB66 fully protect against the transmission of HIV and genital herpes?

MB66 has just begun the first phase of safety evaluation in humans. The safety and efficacy of MB66 will continue to be evaluated in large clinical trials (phases II and III) over the next several years.

Does MB66 act as a contraceptive?

The current version of MB66 does not have contraceptive abilities. However, the next generation of MB66 will include an antibody to sperm that may be able to prevent pregnancy.

How is MB66 different from a condom?

Although condoms are effective methods for the prevention of pregnancy and STIs, new MPTs such as MB66 may have greater social acceptability that result in more reliable, sustained use. MB66 would be used by a woman before having sex and is not reliant on her sexual partner.

MB66 has been referred to as “novel.” What makes it novel?

MB66 is an antibody-based product that is highly specific only for target pathogens. It works on the same theory as mother’s breast milk, which contains antibodies that are delivered to the mucosa of the gastrointestinal tract of infants. But MB66 is novel because antibodies have not historically been used as drugs for mucosal delivery due to cost and scale challenges. MB66’s method of manufacturing and delivery may address these limitations.

Is MB66 safe?

Safety must be demonstrated to the Food and Drug Administration in all three phases of clinical trials; MB66 is initiating the first phase of these trials.

Is MB66 available to consumers? If not, when will it be?

MB66 is not yet commercially available. Assuming MB66 is shown to be safe and effective in all three phases of clinical trials, Mapp may submit an application to the FDA for marketing. Clinical evaluation of MB66 is likely to continue for at least five more years.

How did MB66 get its name?

Unlike other treatments being developed by Mapp, such as ZMapp, MB66 is not a commercial name. Instead, it is a laboratory-based designation. The “MB” represents the initials of Mapp Biopharmaceutical; the number “66” was randomly selected.

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