K.M. Tietz, C. Groberg, C. Jennings, H. Sodowalla, A. Allen, A.J. Tabor, R.S. Kellar, D.R. Walley
NEXT Life Sciences, Inc.,
South Africa
Keywords: male contraceptive, on demand reversible, hydrogel, contraception, plan A
Summary:
The United Nations Population Fund reports that almost 50% of all pregnancies are unintended. Accessibility to contraception is key to the prevention of unintended pregnancies. Most contraceptive options available on the market target female contraception. Male contraceptive methods are limited compared to those available to women, and none are designed to be long-acting and reversible. The only commercially available contraceptive options for men are condoms (short-acting, high failure rate, reversible) and vasectomy (long-acting, somewhat permanent, difficult to reverse). Many men desire new options for male birth control. In the U.S., a survey by the Male Contraceptive Initiative showed that about 17 million men aged 18 to 44 are interested in new birth control methods that fit their lifestyles and relationships. They found that men prefer non-hormonal methods (80%) over hormonal ones (38%) and that 89% think it is important for birth control to be reversible. There is a clear need for a reversible, non-hormonal male contraceptive. A hydrogel is a water insoluble polymer network that can absorb vast amounts of water. Once swollen, hydrogels are flexible with a structure that mimics natural tissue. These polymeric biomaterials have tunable properties, allowing them to be designed for many different applications. Hydrogels can be considered the synthetic equivalent to biological tissues due to their unique characteristics including water transport, softness, porosity and increased biocompatibility. These highly biocompatible materials have revolutionized biomedical applications by seamlessly integrating with the human body. The use of hydrogels as contraceptives is not a new concept, with numerous publications in the literature focusing on hydrogels designed for both female and/or male contraception. These various hydrogels have different mechanisms of action, including but not limited to, physical barrier, spermicidal effects and controlled drug release. However, very few of these formulations have advanced beyond the developmental stages. Plan A™ is a proprietary medical device contraceptive system consisting of an implantable hydrogel solution (Vasalgel®), a Delivery Device and a Reversal Device. The Plan A™ Male Contraceptive System is intended for adult men seeking a non-hormonal, long-acting, non-permanent, easily reversed contraceptive method through occlusion of the vas deferens. This presentation will outline the preclinical development of Vasalgel®, the one component poly(styrene maleic acid) hydrogel that is responsible for providing long-lasting and on demand reversible vas-occlusive contraception. This preclinical summary will demonstrate the safety and efficacy of Vasalgel® as a male contraceptive, covering its vas occlusion and permeability, mechanical and physical properties, on demand reversibility, long-term safety and efficacy, as well as biocompatibility, highlighting this promising contraceptive option for men. Vasalgel®, the technology described in this presentation, was initially developed by the Parsemus Foundation in 2011. In 2022, NEXT Life Sciences, Inc. (NLS) acquired the exclusive worldwide license for this technology and is now developing the improved proprietary medical device contraceptive system called Plan A™. NLS is targeting a commercial release of Vasalgel® in 2027. This presentation will showcase the transition from laboratory discovery to real-world medical treatment and the regulatory efforts involved in achieving this milestone in the male contraceptive landscape.