Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

VivaGel® is under investigation for both the short term treatment and longer term suppression of recurrence of BV in women.  This initial phase of the clinical program will investigate the treatment of BV with a once daily for seven days treatment of VivaGel® and its findings will guide further investigation of suppression of recurrence.

The study will be conducted under an investigational new drug application (IND) at sites in US and will enroll 132 women.  Final preparations are already well advanced and it is expected that the study will commence within a month. The primary objective of the study is to identify the efficacy and optimal dosing for VivaGel® for BV with three strengths (0.5%, 1% and 3%) being compared with a placebo gel. Subjects will be assessed at the end of treatment and then two to three weeks after the end of treatment.

BV is the most common vaginal infection worldwide, and the most common cause of vaginal irritation, discharge and malodor. It is particularly prevalent in the US, where it affects an estimated one-third of the adult female population.  The condition is implicated in pelvic inflammatory disease and may also be associated with an increased risk of sexually transmitted infections, including HIV, and pre-term birth.

The global market for topical BV treatments alone is estimated at approximately US$350M.  The current treatment for BV with conventional antibiotics (orally or topically) is acknowledged to be inadequate by clinicians with high recurrence rates and common side effects.  Current treatments may lead to the development of drug resistance, increased susceptibility to thrush (candidiasis), and drug interactions and topical treatments are often incompatible with condoms.  Earlier trials of VivaGel® for BV have shown no signs of these issues and VivaGel® is designed to be used with condoms.

Dr Jackie Fairley, Chief Executive Officer of Starpharma, said: "The commencement of our BV program is an important milestone in VivaGel®’s development. The treatment and suppression of recurrence of BV opens up a whole new  application for the product in an attractive, established market. Feedback we’ve received suggests that a product without the drawbacks of a conventional antibiotics and designed for use during sex, is likely to be very well received indeed.”

VivaGel® is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating in collaboration with SSL International. Other indications are also under assessment, including prevention of human papillomavirus, and other STIs.

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