Sustained release of lactic acid from an intravaginal device (Vaginal ring)
We seek funding to optimize and clinically validate a lactic acidU+2010eluting system to combat and prevent recurrent bacterial vaginosis in humans. Under physiological conditions, the vagina harbors a commensal microflora primarily consisting of lactic acidU+2010producing lactobacilli, thus creating an acidic environment (pH 3.5U+20104.5) which provides natural antimicrobial protection to the lower female genital tract. However, during bacterial vaginosis (BV, the most frequently occurring perturbation of the vaginal niche) most of the indigenous lactobacilli are lost and replaced by a complex polymicrobial system of anaerobic microbiota. As a result of the loss of lactobacilli and the drop in lactic acid production, the vaginal pH rise above 4.5.
Up to 1/3 of women in Western countries suffer from BV. BV causes vaginal irritation, discharge and malodour. Moreover, infections can lead to ascending genital tract infection and cause abortion, preterm birth or uteritis. BV is also a prominent risk factor to the acquisition of sexually transmitted diseases (HPV, HIV).
Current therapy focuses on antibiotic treatment which is effective for shortU+2010term cure. However, about 50% of women suffer from recurrent BV. An interesting approach to prevent recurrent BV is the longU+2010term vaginal supplementation of lactic acid as evidenced by a limited number of clinical trials. Several lactic acid containing gels for intravaginal application are on the market as U+201CverU+2010theU+2010counterU+201D(OTC) products. However, major drawbacks are i) difficulty to apply; ii) need for frequent application; iii) gel leakage; iv) risk of U+201CverdosingU+201Dand tissue damage. This leads to poor patient compliance. We propose an easyU+2010toU+2010use and effective intravaginal system composed of a polymeric ring eluting lactic acid over a prolonged period, thus avoiding frequent administration, while ensuring continuous acidification of the vagina (pH 3.5U+20104.5). It is envisaged that such a system can be developed into an OTC product with a low regulatory threshold (medical device).
A prototype has been developed and financed by the applicants allowing the sustained release of acid over a period of up to 10 days. Further development and evaluation is required to make the system attractive to industry. The aim of the project is twofold:
- to optimize the device (composition) as to make it more effective (acid release profiles), patient friendly (shape, flexibility) and industrially applicable (GMP oriented development);
- to clinically validate the system in humans. InvestigatorU+2010driven phase I and phase II clinical trials will be pursued to establish the safety and clinical efficacy of the system for the control of recurrent BV.
Validation of the concept of the lactic acidU+2010containing vaginal ring towards the treatment of recurrent BV will derisk the project in terms of clinical efficacy, easeU+2010ofU+2010manufacturing and easeU+2010ofregistering. This will increase the opportunities for successful partnering with an industrial partner that is capable of further developing, registering, producing and marketing the product for worldwide markets.