WOM-iCARE – topical surfactant-based hydrogel for prevention and treatment of skin and/or mucosal infections or disorders
An antibactericidal hydrogel for enhanced skin and/or mucosal infection control. Topical administration, effective and safe. No microbial resistance.
BACKGROUND
Sexually transmitted infections (STIs) are a serious public health and socioeconomic problem. These infections predominantly spread through unprotected sexual contact and can also be transmitted from mother to child during pregnancy and childbirth. Current efforts to treat these infections are ineffective: prophylactic vaccines are not yet a reality, and current therapeutic treatments with antibiotics are being challenged by the rise of antimicrobial resistance. This is particularly the case for STIs caused by N. gonorrhoeae, the etiological agent of gonorrhea, the second most common STI worldwide, with the WHO estimating 82.4 million new infections among adults aged 15–49 years in 2020. N. gonorrhoeae is currently resistant to almost all classes of antimicrobials available and has been recognized by the WHO and the Center of Disease Control as a “superbug” that may soon become untreatable. Therefore, there is an urgent need to develop novel antimicrobial formulations to treat N. gonorrhoeae infections.
WOM-iCARE offers a promising solution to this escalating problem. Specifically designed to combat bacterial infections, such as N. gonorrhoeae, it provides targeted prevention and treatment. By combining effectiveness, safety, and affordability while circumventing microbial resistance, this technology represents a critical advancement in infection control.
WOM-iCARE can also be used to treat and prevent infections caused by: Chlamydia trachomatis, Streptococcus agalactiae, Staphylococcus aureus Staphylococcus epidermidis, Pseudomonas, aeruginosa, Mycoplasma genitalium, Gardnerella vaginalis, Treponema pallidum, Haemophilus ducreyi, Klebsiella granulomatis (or Calymmatobacterium granulomatis) or mixtures thereof.
TECHNOLOGY OVERVIEW
Figure 1.
WOM-iCARE is a safe, effective and a large spectrum bactericide-containing hydrogel, offering targeted bacterial infection control without inducing resistance and without reported adverse effects to the vaginal mucosa or changes in the vaginal microbiome in mice. So far, a proof of concept has been performed in vivo, demonstrating the effectiveness and safe profile of this product for infections caused by N. gonorrhoeae, a Gram-negative bacteria.
The antibiotic-free cationic surfactant-based cellulose hydrogel contains a cationic short-chain quaternary ammonium surfactant, specifically N-dodecylpyridinium bromide (C12PB) as the active principle, that specifically induces the death of bacteria without compromising the eucaryotic cells or the vaginal microbiome.
The hydrogel is a biocompatible cellulose-based polymer, made of Hydroxyethylcellulose and hydroxypropylmethylcellulose.
The WOM-iCARE was tested in vitro and in vivo in an ovariectomized BALB/c mice infected with N.gonorrhoeae. The experiments showed that:
- C12PB maintained its antibacterial activity when conjugated with the hydrogel (Article Figure 5).
- C12PB loaded hydrogel has a safe profile:
- Preserved mammalian Caco-2 epithelial cells viability and mouse mucosa integrity (through histopathology of the vagina, cervix, uterus, and ovary tissue in Balb/c mice upon intravaginal administration (Article Figure 5 and Figure 7).
- C12PB loaded hydrogel did not induce enhanced expression of inflammatory cytokines in Caco-2 (Article Figure 5).
- the vaginal mucosa histological analysis indicated that the intravaginal administration of C12PB-hydrogels up to the critical micelle concentration (CMC)/5 in BALB/c mice only induced a moderate to minimal inflammatory in both the submucosa and muscle layer of the uterus (Article Figure 7).
- did not induce changes in the vaginal microbiome in mice, suggesting that vaginal health was preserved (Article Figure 8).
- Selectivity towards gonorrhoeae in comparison with host cells and vaginal microbiome (Article Figure 5 and Figure 8).
- Did not induce antimicrobial resistance and antibiotic cross-resistance (Article Fig 2).
- Sustained and controlled drug release (Article Figure 4 and Figure 6)
- A single application of WOM-iCARE reduced gonorrhoeae in a mouse model of gonorrhoeae infection (Article Figure 8).
- WOM-iCARE MVP was developed aiming for a comfortable and localized delivery method due to the hydrogel characteristics – it absorbs large quantities of water while maintaining a gel-like consistency. It can be self-administrated, it is odorless and colorless, and of easy removal, providing a comfortable and unobtrusive delivery method that will ensure, in the future, ease of use and contribute to patient satisfaction.
FURTHER DETAILS
Calado R.D.A., Mendes, B.B., Conniot J., Ravasco J. M. J. M., Sobral D., Ferreira C., Ferreira R., Rodrigues J.C., Santos D., Duarte S., Vieira L., Inácio A.S., Carrêlo H., L.C. Vaz W.L.C., Paulo Gomes J.P., Nunes A., Conde J., O. V. Vieira. Preclinical assessment of an antibiotic-free cationic surfactant-based cellulose hydrogel for sexually and perinatal transmitted infections. Matter 2024, 7(6), pp.2205-2235.doi.org/10.1016/j.matt.2024.04.002.
STAGE OF DEVELOPMENT
TRL 3 – experimental proof of concept
WOM-iCARE, an antibiotic-free cationic surfactant-based cellulose hydrogel, is highly effective in a preclinical model of N. gonorrhoeae infection, where a single application showed a 2- to 3-fold infection reduction, while not disrupted the integrity of the vaginal epithelial barrier, induced mucosal inflammation, interfered with the innate immune response, or alter vaginal flora.
Other applications for different bacterial infections, whether in the mucosa or the skin, can be studied.
BENEFITS & APPLICATIONS
WOM-iCARE presents a superior alternative to current treatment options (antibiotics) as it offers the following benefits:
- Efficacy: Demonstrated efficacy in reducing gonorrhoeae infection in preclinical models, with just one application, encouraging adherence and consistent use.
- Safety: No inflammatory response or damage to vaginal mucosa observed, and no perceptible impact on vaginal microbiome, enhances its acceptance for prophylactic use.
- Antimicrobial Resistance: Does not induce antimicrobial resistance, offering a sustainable solution.
- Accessibility: Low production costs, stable shelf-life at room-temperature ensure reduced production and distribution costs. It also dispenses the need of trained professionals to administer the treatment.
- Ease of Use: odorless, colorless, and user-friendly gel formulation allows for convenient self-administration, and easy removal, enhancing patient adherence to therapy thus reducing healthcare system burden.
WOM-iCARE is suitable for use as a microbicide in topical treatment and prophylaxis of N. gonorrhoeae.
Particularly, we have also demonstrative data on the high efficacy of WOM-iCARE against Streptococcus agalactiae. This bacterium is responsible for most of the newborn infections and is transmitted from mother to child during pregnancy and childbirth.
Other target infections include: Chlamydia trachomatis, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Mycoplasma genitalium, Gardnerella vaginalis, Treponema pallidum, Haemophilus ducreyi, Klebsiella granulomatis (or Calymmatobacterium granulomatis).
INTELLECTUAL PROPERTY
- SURFACTANT-BASED HYDROGEL, METHODS AND USES THEREOF (EP24160080.8, priority date: 16/02/2024)
Applicants: NOVA University Lisbon (PT) and Instituto Ricardo Jorge (PT)
OPPORTUNITY
Seeking co-development partners to mature WOM-iCARE to highest TRLs
Open to opportunities for exclusive and non-exclusive licensing
Open to funding to establish a spinout
NOVA Inventors
Otília Vieira
João Conde
Bárbara Mendes
João Conniot
Rita Calado
Winchil Luís
