- VivaGel® BV consistently resulted in reduced rates of BV recurrence by the primary efficacy endpoint and five secondary efficacy measures, and delayed time to first recurrence
- VivaGel® BV resulted in sustained benefits 3 months after cessation of treatment
- The majority of women who used VivaGel® BV in both studies remained BV-recurrence-free during the 16-week treatment phase
- VivaGel® BV demonstrated excellent safety and tolerability, including very low rates of candidiasis
- These trial results strongly support marketing applications to US FDA and other regulators for rBV indication and add significant commercial value to VivaGel® BV
- FDA QIDP and Fast Track designations already granted for VivaGel® BV, providing significant commercial and regulatory advantages
- VivaGel® BV New Drug Application (NDA) is well-advanced for both BV indications (treatment and prevention of rBV)
- Phase 3 trial data significantly enhances the commercial opportunity for VivaGel® BV through the ongoing licensing process, facilitated by a global healthcare investment bank
Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that its two phase 3 trials of VivaGel® BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective demonstrating statistically significant superiority compared to placebo in preventing rBV based on topline data.
Starpharma intends to submit a marketing application to the FDA for VivaGel® BV for prevention of rBV based on these positive results. There are currently no approved products for the prevention of rBV, which is a significant unmet medical need.
Dr Jackie Fairley, Starpharma Chief Executive Officer said: “We are delighted to report these successful phase 3 trial results, in which VivaGel® BV has demonstrated compelling efficacy in all six primary and secondary efficacy measures. Our NDA for VivaGel® BV for both treatment and rBV is well-advanced, and we’ll be using these data to complete the clinical package for submission to the FDA and other regulatory authorities.”
“There’s a desperate need for new therapeutic options for BV, a serious condition that affects nearly 1 in 3 women globally. The fact that VivaGel® BV is not a conventional antibiotic and specifically targets BV bacteria, makes it a particularly appealing solution for patients. It also represents a highly attractive commercial proposition especially given it will be first in class for the prevention of rBV. VivaGel® BV has potential to gain a significant share of this market, which is estimated to be in excess of US$1 billion per annum globally,” added Dr Fairley.
“Antibiotic resistance is a major issue globally and VivaGel® BV offers an alternative to conventional antibiotic therapies for BV. We know that patients and clinicians are very attracted to the non-antibiotic nature of the product, its novel mechanism of action on biofilm, and the fact that it is not absorbed into the bloodstream contributing to its excellent safety and tolerability profiles,” concluded Dr Fairley.
Next Steps
These trial results strongly support marketing applications to the US FDA and other regulators for the BV prevention indication and add significant commercial value to VivaGel® BV.
The FDA new drug application (NDA) for VivaGel® BV for both treatment and rBV is well-advanced and data from the trials reported today will be incorporated to complete the clinical package. The NDA will be submitted to the FDA as soon as practicable with the initial sections of the rolling submission due for lodgement shortly. Throughout the preparation of the NDA, Starpharma continues to leverage the QIDP designation and Fast Track status granted by the FDA for VivaGel® BV. These designations carry significant benefits for regulatory approval and commercialisation, including increased dialogue with the FDA, priority regulatory review and an additional five years of market exclusivity. Starpharma also has a Special Protocol Agreement in place from the FDA for VivaGel® BV which provides binding FDA agreement on the phase 3 trial design.
In addition, the data from these trials will also be submitted to other regulatory authorities including in Europe, to expand the indications for VivaGel® BV to include rBV.
Negotiations are continuing with a number of parties for regional and global commercial rights to VivaGel® BV. These trial results confirm the product’s utility in both treatment and rBV and will have a significant positive impact on value. Starpharma has recently appointed a leading global healthcare investment bank to support the competitive process and for finalising commercial arrangements with potential partners.
About VivaGel® BV
VivaGel® BV is a water based gel for topical treatment and rapid relief of bacterial vaginosis (BV). It is based on Starpharma’s SPL7013, astodrimer sodium, a proprietary dendrimer that blocks certain bacteria involved in BV and also has potent antiviral activity against certain viruses (HIV, HSV, HPV, Zika).
The VivaGel® BV treatment product, which is already approved in Europe, targets an area of significant unmet medical need in a high-value market (est. US$750M) and has been licensed to Aspen Pharmacare with preparations underway for launch. A second VivaGel® BV product recently completed phase 3 clinical development for the prevention of recurrent BV which is another high value market (est. US$1B) for which there are currently no clinically approved products.
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