Fast dissolving MM008 tablet for instant on-demand non-hormonal contraception

The National Institute of Child Health and Human Development (NICHD) awarded Mucommune LLC a $1.13M Project Grant under the Child Health and Human Development Extramural Research program (CFDA 93.865) on September 15, 2025, to develop MM008, a fast-dissolving tablet contraceptive product. The project, which will conclude on August 31, 2027, focuses on formulating the company's proprietary highly multivalent anti-sperm monoclonal antibodies (MAB)—specifically engineered molecules designated FFIFF and LAMH10—into fast-dissolving antibody tablets (FDATs). This non-hormonal contraceptive is designed to address the substantial market gap for women seeking on-demand contraception that is fast-acting, effective, safe, discreet, and hormone-free, thereby addressing the significant proportion of unintended pregnancies in the United States that occur among women avoiding hormonal contraceptive methods.

The underlying technology leverages Mucommune's proprietary monoclonal antibodies that specifically target antigens present exclusively on human sperm and male reproductive tissue, enabling the FDATs to agglutinate and trap sperm in cervicovaginal mucus and thereby prevent sperm from reaching the egg. This development represents a novel delivery mechanism and contraceptive approach that aims to overcome limitations inherent in current on-demand options such as gels, films, and condoms, which often suffer from limited effectiveness, toxicity concerns, or inconvenient dosing requirements.

Abstract

Nearly half of all pregnancies in the U.S. Are unintended, and most occur in women who are not using contraceptives. There are diverse reasons for not using contraceptives; one common reason is that many women have strong aversion to using exogenous hormones, due to real and/or perceived side effects. Furthermore, women's contraceptive preferences are diverse: while some strongly prefer the convenience and sustained contraceptive activity of an intravaginal ring (IVR), others strongly prefer discrete methods that can be used on-demand during infrequent intercourse. Thus, a suitable delivery format is equally important as the underlying contraceptive mechanism. Current on-demand contraceptive options, such as gels/films/condoms, each faces substantial limitations, including limited effectiveness, substantial toxicity, and/or inconvenient dosing timing and format. A non-hormonal contraceptive that is fast-acting with prolonged (i.e. many hours of) activity, safe, effective, not messy and discreet would meet the needs of many women seeking on-demand contraception, but are not met by any of the currently available contraceptive products. We are creating such a non-hormonal contraceptive (product code: MM008) by formulating mucommune's proprietary highly multivalent anti-sperm monoclonal antibodies (MAB) into fast dissolving antibody tablets (fdats). We previously developed a MAB termed ffiff that binds a well-characterized and validated antigen target present only on human sperm and cells from the male reproductive tract, but are otherwise absent in all tissues in women. Due to its highly multivalent nature, ffiff potently agglutinate and trap sperm in CVM (>16-fold greater than parent HC4 MAB in standard IGG format), thus effectively preventing individual progressively motile sperm from reaching the EGG. More recently, we engineered an improved molecule termed LAMH10, which possess even greater avidity and potency against sperm at physiological temperature (37˚c), exceeding the activity of the parent HC4 IGG by over 100-fold. We have also successfully formulated LAMH10-fdats, comprised of a proprietary blend of safe and routinely used excipients, with rapid disintegration (99.9% in the sheep vagina within