VivaGel® is being developed as a treatment for, and to prevent recurrence of, bacterial vaginosis (BV). BV is caused by an imbalance of the normal vaginal bacterial microflora, with healthy bacteria (e.g. Lactobacillus species) being depleted and harmful bacteria (e.g. Gardnerella vaginalis) overly abundant.
Two concurrent pivotal Phase 3 clinical trials of VivaGel® for the treatment of bacterial vaginosis (BV) will take place at 30 international sites, and enrol approximately 220 participants each. The results of the trials are anticipated by the end of 2012. VivaGel® for the treatment of BV has received a Special Protocol Assessment or SPA by the FDA. An SPA is a declaration from the FDA that a Phase 3 trial’s design, clinical endpoints, and statistical analyses are approvable by the FDA once completed to a pre-agreed level. This early clarity reduces the risk inherent in regulatory processes. VivaGel® has been shown to have efficacy for treatment of BV in a Phase 2 clinical study.
Throughout the world, BV is the most common vaginal infection. For example in the US, an estimated 21 million women aged 14-49 years (approximately 29%) are infected with BV. BV leads to symptoms including vaginal irritation, abnormal vaginal discharge and odour that are unpleasant and disrupt and interfere with a woman’s relationships and general quality of life. BV has also been linked to serious public health consequences including acquisition and transmission of sexually transmitted infections (STIs), including HIV. Studies indicate that more than 30% of HIV infections in women could be prevented if BV was successfully treated.
It is commonly recognized that the existing therapeutic options for BV are inadequate because of low cure rates, high rates of recurrence, potentially severe systemic adverse effects and, for some products, incompatibility with alcohol consumption or condoms. Existing antibiotic approaches are not considered suitable for long-term maintenance therapy. In contrast, VivaGel® is well tolerated, is not absorbed (and so is free from systemic effects), can be used with condoms, and has the real potential to be used for prolonged periods to prevent recurrence of BV.
The global market for topical BV treatments alone is estimated at approximately US$350M. Starpharma’s modelling suggests the addressable global market for prevention of recurrence of BV is potentially in excess of $1 billion, due to the long term usage associated with such a product.
VivaGel® is undergoing clinical evaluation to assess its ability to treat BV and prevent recurrence of BV.
