- VivaGel® BV
demonstrated statistically significant efficacy in two pivotal
phase 3 trials
- 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.
The two double-blind, randomised, placebo-controlled trials,
SPL7013-017 (017 US trial) and SPL7013-018 (018 European trial),
were identical in design and enrolled 1,223 women who had a history
of rBV. A history of rBV was defined as at least three episodes of
BV in the preceding 12 months (i.e. average of at least one
recurrence every 16 weeks). Trial participants used either VivaGel®
BV (1% SPL7013 Gel) or placebo gel on alternate days for 16 weeks.
The 017 US trial was conducted at sites in the US, Puerto Rico,
Canada and Mexico, and the 018 European trial was conducted at
sites mainly in Europe but also included some sites in Thailand and
the US.
The primary endpoint of both studies was BV recurrence at or by
week 16 as diagnosed by clinical findings (i.e. presence of three
out of four Amsel criteria). For the primary efficacy analyses, any
patients who failed to attend the Week 16 visit were deemed to have
recurred i.e. were imputed to failure (even if in reality they
remained BV free), making this a very rigorous efficacy result.
In the 017 US trial, the rate of BV recurrence at or by Week 16
(i.e. the primary endpoint) in the VivaGel® BV group was 44.2%
(statistically significant versus placebo 54.3%, P=0.015, N=585).
Actual BV recurrence rates, not imputing missing data to failure,
were even lower at 34.9% for VivaGel® BV and 46.6% for placebo.
It has been observed in the literature that vaginally delivered
placebos can have effect on BV, as was seen in both these
trials. Therefore, in assessing the patient benefit of
VivaGel® BV in this trial (apart from comparing to placebo) it is
also useful to refer to expected rates of BV recurrence over a
16-week period without any intervention at all (i.e., placebo or
active). Recurrence rates over 16-weeks in untreated rBV patients
range between 65-85% in the literature. In addition, a 16-week
Historical Recurrence Rate (HRR) using the trial participants’
historical BV recurrences immediately prior to commencing the trial
was estimated. This 16-week Historical Recurrence Rate for the
trial participants in the 017 US trial was approximately 65%.
In the 018 European trial, the rate of BV recurrence at or by
Week 16 in the VivaGel® BV group was just 15.7% (statistically
significant versus placebo 22.6%, P=0.027, N=636). In comparison,
the 16-week Historical Recurrence Rate (without intervention) for
the 018 European trial participants was approximately 50%.
Given the rates of BV recurrence in the 018 European trial were
lower than expected, and low compared with the 017 US trial, an
investigation was conducted prior to data unblinding, and efficacy
analyses (additional analysis) were also conducted on a modified
subset population. This additional analysis excluded a number of
sites in countries (e.g., Ukraine and Romania) where recurrence
rates were lower than anticipated. In this additional analysis, the
same pattern of benefit of reduced recurrence was also demonstrated
for VivaGel® BV compared with placebo as for the full analysis,
although due to the reduced sample size in this subset compared
with the full analysis, the difference was not statistically
significant (VivaGel® BV recurrence rate 28.2% versus placebo
33.9%, P=0.266, N=327).
In addition to the individual trial results reported above, when
the data from both trials is combined, statistically significant
differences between the rates of BV recurrence in the VivaGel® BV
group versus placebo are also clearly demonstrated (017 US trial
plus 018 European trial full analysis P=0.002, 017 US trial plus
018 European trial additional analysis P=0.014).
Further to the compelling benefits of VivaGel® BV in the primary
endpoint, VivaGel® BV demonstrated statistically significant
benefits compared with placebo in five secondary efficacy
endpoints, including:
- Time to recurrence of BV (017 US
trial P=0.007; 018 European trial full analysis P=0.009, additional
analysis P=0.055);
- Reduced recurrence of patient
reported symptoms of vaginal odour and/or discharge (017 US
trial P<0.001; 018 European trial full analysis P=0.019,
additional analysis P=0.032);
- Reduced recurrence of BV by Nugent
score of 7-10 (017 US trial P=0.012; 018 European trial full
analysis P=0.002, additional analysis P=0.016);
- Reduced recurrence of BV by clinical
findings (i.e. 3 out of 4 Amsel criteria) and Nugent score
greater than or equal to 4 (017 US trial P=0.008; 018 European
trial full analysis P=0.014, additional analysis P=0.045); and
- Reduced recurrence of individual
Amsel criteria as assessed by clinicians, including discharge
(017 US trial P=0.015; 018 European trial full analysis P=0.011,
additional analysis P=0.012), positive whiff test (017 US trial
P=0.082; 018 European trial full analysis P=0.010, additional
analysis P=0.022) and clue cells (017 US trial P=0.014; 018
European trial full analysis P=0.001, additional analysis
P=0.008).
VivaGel® BV also resulted in sustained benefits well beyond
cessation of treatment. Reduced recurrence of BV by the primary and
secondary efficacy endpoints (including discharge, odour and
clinical findings) were observed not only during the 16-week
treatment period, but were also sustained during the 12-week
follow-up period off-treatment.
Starpharma greatly appreciates the time and effort of the many
women who volunteered for participation, along with the excellent
support of clinicians and healthcare professionals in these
trials.
Results commentary
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170807005403/en/
MediaWE BuchanRebecca Wilson, +61 417 382
391rwilson@buchanwe.com.auArthur Chan, +61 2 9237
2805achan@buchanwe.com.auorStarpharmaDr Jackie FairleyChief
Executive OfficerNigel Baade, +61 3 8532 2704CFO and Company
Secretaryinvestor.relations@starpharma.com
Starpharma (ASX:SPL)
Historical Stock Chart
From Oct 2024 to Nov 2024
Starpharma (ASX:SPL)
Historical Stock Chart
From Nov 2023 to Nov 2024