Starpharma Holdings Ltd (ASX:SPL) (OTCQX:SPHRY) today announced that the
US Food and Drug Administration (FDA) has granted Special Protocol
Assessment (SPA) agreement on the design and planned analyses of the
phase 3 clinical studies of the VivaGel® bacterial vaginosis
(BV) product for the prevention of recurrent BV.
The favourable SPA outcome provides a binding agreement from the FDA
that the phase 3 clinical study design, endpoints, statistical analyses
and other aspects of the planned studies adequately address objectives
in support of a US regulatory submission for approval of the product.
The granting of SPA agreement by the FDA follows the earlier agreement
of the European Medicines Agency (EMA) on the design of the phase 3
Starpharma will now commence its two pivotal phase 3 clinical trials of
VivaGel® for the prevention of recurrent BV at sites in North
America, Europe and Asia.
The two phase 3, double-blind, randomised, placebo-controlled trials
will be identical in design and will compare the rate of BV recurrence
in women using VivaGel® to the rate of recurrence in women
using a placebo gel during a 16 week treatment period. Approximately 600
women will be recruited into each study.
Starpharma Chief Executive Officer, Dr Jackie Fairley, said: "Receiving
agreement on the SPA is an important and very positive development as it
effectively eliminates the US regulatory risk associated with clinical
development, by specifying upfront the FDA's agreed trial design. This
significantly reduces overall development risk for VivaGel®.
SPA agreement from the FDA is protected by US law and gives Starpharma
certainty and confidence that the studies will support a regulatory
submission for the approval of VivaGel® for the prevention of
recurrent BV in the US."
VivaGel® (SPL7013, astodrimer sodium) is a non-antibiotic
agent formulated as a vaginally applied gel for prevention of BV
recurrence. It is also being developed for the management of BV
symptoms, which include unpleasant vaginal odour and discharge, and
regulatory submissions to support the symptomatic relief indication are
also planned for 2HCY14.
There are no approved products for the prevention of recurrent BV and so
VivaGel® will be a world-first therapy for this troublesome
condition. Bacterial vaginosis affects around 1 in 3 women and recurs in
approximately 50 per cent of women within 12 months.
In the previous exploratory phase 2 clinical trial, more than 80 per
cent of women receiving 1% VivaGel® remained BV-free at 16
weeks and the product also provided protection against the occurrence of
BV symptoms. Formal market research with both patients and clinicians
and from Key Opinion Leaders strongly supports the demand for a product
such as VivaGel® in the management of BV.
Bacterial vaginosis is the most common cause of vaginal infection for
women of childbearing age affecting around 30% of women in the US. It is
a highly recurrent condition with 50-60% of sufferers having it
recurrently. Bacterial vaginosis is caused by an imbalance of naturally
occurring bacterial flora (the usual bacteria found in a woman's
vagina). Smoking and the use of some hygiene products are linked to a
higher risk of developing BV.
BV results in unpleasant and embarrassing symptoms such as odour and
vaginal discharge. It has been linked to still birth, pregnancy
complications, pelvic inflammatory disease, and lower rates of
fertility. It also is associated with increased susceptibility of women
to HIV and other STIs, and an increased risk of transmission of HIV from
women to men.
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