Starpharma Holdings Limited announced that the phase III clinical trial programme for the VivaGel bacterial vaginosis (BV) treatment programme has been agreed with the US Food and Drug Administration (US FDA) following recent positive trial results and subsequent End of phase II (EOP2) Meeting.
With very positive phase II results for VivaGel in the treatment of BV (announced May 2011), Starpharma recently presented to the US FDA the proposed design of phase III studies and associated aspects of the development programme to support a New Drug Application (NDA) for VivaGel for the treatment of BV.
Following these EOP2 meeting discussions, Starpharma and the US FDA are now in agreement on phase III clinical trial design, including definition of primary and secondary endpoints, patient numbers and other design parameters. The company now plans to submit its phase III protocols as soon as possible and it is anticipated that the trials will commence in early 2012 with completion expected before year end. Following the completion of phase III trials the company plans to partner the product.
Consistent with Starpharma’s original plans for the BV treatment programme, these two phase III studies will be conducted in parallel, each with approximately 220 participants enrolled. In these phase III trials, as for the recently completed successful phase II study, the primary endpoint will be Clinical Cure, as assessed by resolution of symptoms and other standard clinical criteria, and the comparator will be placebo gel.
“We are very pleased that the US FDA agreed with our proposed clinical program in this important, final phase of the development of VivaGel as a treatment for bacterial vaginosis and particularly that the design is so similar to our successful phase II trial. We look forward to advancing the programme as rapidly as possible, and to executing a commercial licence following its completion,” said Starpharma CEO, Dr Jackie Fairley.
“BV is the most common vaginal infection in the world, and affects an estimated one-third of the adult female population in the US. The global market for topical BV treatments alone is estimated at approximately US$ 350M and we and others believe VivaGel has the potential to be a very important product in the management of this serious and unpleasant condition.”
In May, Starpharma announced that VivaGel had met the primary endpoint of its phase II study, demonstrating significant efficacy for treatment of BV. The study showed that treatment with 1 per cent VivaGel once daily for seven days, resulted in 74 per cent of patients achieving Clinical Cure of BV 2 to 5 days after completion of therapy compared with just 22 per cent in the placebo group (P=0.0002). In addition, patient acceptability of the product was very high with 83 per cent of patients using 1% VivaGel® being extremely satisfied, very satisfied or satisfied with the product when taking all aspects of the treatment into account.
Bacterial Vaginosis is the most common vaginal infection worldwide and is particularly prevalent in the US. Similar to imbalances between “good” and “bad” bacteria in the gut, an imbalance in the vaginal microbiota between good bacteria - which help maintain a normal healthy vagina - and harmful bacteria, leads to BV with symptoms including vaginal irritation, discharge and odour that are unpleasant and disrupt and interfere with a woman’s relationships and general quality of life. The condition also has more serious consequences, being implicated in pelvic inflammatory disease, infertility and an increased risk of pre-term birth. BV also significantly increases the risk of some sexually transmitted infections, including HIV.
Starpharma Holdings Limited is a world leader in the development of dendrimer technology for pharmaceutical, life-science and other applications.
Starpharma’s ADRs trade under the code SPHRY (CUSIP number 855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the Australian Securities Exchange (ASX). Starpharma’s ADRs are listed on International OTCQX, a premium market tier in the US for international exchange-listed companies, operated by OTC Markets Group Inc.