Combination product for the prevention of sexually transmitted infections
Inventors
O'Keefe, Barry R. • Robbiani, Melissa • Romero, José A. Fernández
Assignees
Population Council Inc • Government of the United States of America
Publication Number
US-11331370-B2
Publication Date
2022-05-17
Expiration Date
2035-01-13
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Abstract
Disclosed are compositions for inhibiting transmission of a sexually transmitted infection that contain one or more polyanionic microbicides, such as carrageenans, including lambda carrageenan, as well as water-soluble metal salts and specified lectins. Also disclosed are methods for making and using the compositions.
Core Innovation
There is a worldwide unmet need for technologies that simultaneously protect against human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Previous studies with single active pharmaceutical ingredients (APIs) with broad anti-viral activity have not shown efficacy in clinical trials due to factors including low potency, short window of protection, reduction of activity in biological fluids, or induction of mucosal and microflora changes. Thus, there is a continuing need to identify more potent and safe APIs which may be used alone or in combination for microbicidal use.
Applicants have discovered that microbicidal compositions with broad and extremely potent activity may be produced by combining lectins with a water-soluble metal salt and/or carrageenans. In particular, compositions comprising one or more lectins in combination with a zinc metal salt and/or carrageenan were developed yielding enhanced and synergistic anti-viral activity against HIV, HSV-2, HPV, and other STIs.
The present invention provides antimicrobial compositions which may comprise physiologically acceptable water soluble metal salts, carrageenans (including lambda carrageenan as the major component), and lectins such as Griffithsin. These compositions can be formulated in physical forms suitable for vaginal or rectal administration including gels, solutions, solids, or powders. Methods of inhibiting microbial infection using these compositions are also disclosed, enabling treatment or prevention of vaginal or rectal transmission of STIs.
Claims Coverage
The patent includes multiple inventive features focused on antimicrobial compositions and methods of inhibiting sexually transmitted infections, with claims covering compositions comprising Griffithsin and carrageenan, suppository formulations, and methods of administration against HIV, HPV, and HSV-2.
Antimicrobial composition comprising Griffithsin and carrageenan
An antimicrobial composition comprising an effective amount of Griffithsin and an effective amount of carrageenan.
Antimicrobial composition with excipients and contraceptive agents
The antimicrobial composition can further comprise a physiologically acceptable pH controlling agent, a physiologically acceptable preservative, at least one excipient, and at least one contraceptive agent including zinc acetate as spermicide.
Vaginal or rectal suppository comprising antimicrobial agents
A vaginal or rectal suppository comprising an antimicrobial composition including effective amounts of Griffithsin, carrageenan, and at least one physiologically acceptable excipient, optionally further comprising other anti-microbial agents, pH controlling agents, and contraceptive agents including zinc acetate.
Methods of inhibiting sexually transmitted infections
Methods of inhibiting HIV, HPV, or HSV-2 by administering to a subject an effective amount of the antimicrobial composition comprising Griffithsin and carrageenan, including administration via vaginal or rectal suppositories.
The claims cover antimicrobial compositions primarily comprising Griffithsin and carrageenan with optional metal salts, excipients, preservatives, contraceptive agents such as zinc acetate, various dosage forms including suppositories, and methods for preventing or inhibiting sexually transmitted infections including HIV, HSV-2, and HPV.
Stated Advantages
The compositions provide broad and extremely potent activity against multiple sexually transmitted infections including HIV, HSV-2, and HPV.
The combination of lectins with zinc salts and carrageenans yields synergistic antiviral effects enhancing efficacy.
The compositions avoid use of antiretroviral drugs, reducing the risk of inducing drug resistance and preserving alternative treatment options.
They may be formulated for over-the-counter use, increasing accessibility and affordability, thereby benefiting global public health.
Documented Applications
Prevention of vaginal or rectal transmission of sexually transmitted infections such as HIV, HSV-2, HPV, and others.
Use as a microbicidal composition for inhibiting microbial infection in subjects in need thereof, including treatment or prophylaxis of multiple concurrent microbial infections.
Combination products serving as multipurpose prevention technologies by including contraceptive agents to prevent unintended pregnancy alongside antimicrobial activity.
Formulation in various dosage forms suitable for vaginal or rectal administration including gels, suppositories, creams, foams, films, tablets, intravaginal rings, intrauterine devices, and nanofibers.
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