Full Press Release Details
Aquinox Q2 /2015 Conference Call:
LEADERSHIP Secondary Endpoint Update AQX-1125 in BPS/IC
Forward Looking Statements / Safe Harbor
presentation and the accompanying oral commentary contain forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the
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development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for AQX-1125 and our future product candidates, our intellectual property position, the degree of clinical utility
of AQX-1125 and our future product candidates, particularly in specific patient populations, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition,
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Phase 2 LEADERSHIP Trial
Evaluate the efficacy and safety of AQX-1125 in 69 subjects with moderate to severe BPS/IC pain across Canadian and US
Primary Endpoint: Effect of 6 weeks treatment with once daily AQX-1125 (200 mg) vs. placebo on reduction of average pain score (11-point numerical rating scale (NRS)) vs. baseline,
Secondary Endpoints:
Difference in the change from baseline in the following:
- Average pain score measured by 11-point NRS recorded at clinic
- Maximum daily pain based on an 11-point NRS recorded on eDiary
- O Leary-Sant Interstitial Cystitis Symptom Index and IC Problem Index (ICSI/PI)
- Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS)
- Voiding frequency over a 24 hour period
Safety, Pharmacokinetics
LEADERSHIP: AQX-1125 Reduces Average Daily Pain at 6 Weeks
Change from Baseline Pain (eDiary) Mean (SE)
-3 -2 -1 0 -1.5 -2.5 P=0.061
Endpoint: Average Daily Pain (11-Point NRS, eDiary)
LEADERSHIP: Responder Analysis > 2 pt. Pain Reduction at 6 Wks.
Percentage of Responders
Change from Baseline (Decrease)
Approximately 49% of patients receiving AQX-1125 demonstrated a 2-point or greater reduction
in pain compared to 34% of patients receiving placebo
LEADERSHIP Endpoints Pain
Chief Medical Officer
LEADERSHIP: Greater Average Daily Pain Reduction Over 6
Change from Baseline Pain
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks
P = 0.165 p = 0.086 p = 0.061
LEADERSHIP: Loss of Pain Effect When Treatment Completes: Validates AQX-1125 Activity (eDiary)
Change from Baseline Pain (eDiary)
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks Treatment period
10 Weeks (Follow-up)
LEADERSHIP: Significantly Greater Average Pain Reduction
Over 6 Weeks (Clinic)
-3 -2 -1 0 Baseline 2 Weeks
Change from Baseline Pain (Clinic)
P = 0.070 p = 0.076 ** p = 0.006 Placebo
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks
LEADERSHIP: Loss of Effect When Treatment Completes (Clinic)
Change from Baseline Pain (Clinic)
P = 0.070 p = 0.076 ** p = 0.006 Placebo
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks Treatment period
10 Weeks (Follow-up)
LEADERSHIP: Significantly Reduced Maximum Daily Pain
Over 6 Wks. (eDiary)
Change from Baseline in
Maximum Daily Pain (eDiary)
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks
P = 0.115 p = 0.060 *p = 0.030
LEADERSHIP: Loss of Effect When Treatment Completes
Change from Baseline in Maximum Daily Pain (eDiary)
P = 0.115 p = 0.060 * p = 0.030 p = 0.382
-3 -2 -1 0 Baseline 2 Weeks 4 Weeks 6 Weeks
Treatment period 10 weeks (Follow-up)
LEADERSHIP Secondary Endpoints
LEADERSHIP: Significantly Reduced O Leary-Sant ICSI/PI at 6 Wks.
Change from Baseline ICSI-PI Mean (SE)
-2.8 -7.2 ** p = 0.008 -10 -8 -6 -4 -2 0
Symptom/Problem Indices (ICSI/PI)
validated as an outcome measure for clinical trials1
4 questions about frequency of urinary
symptoms and bladder pain over the past month
Total score ranges from 0-20 points
4 questions about how problematic
symptoms and pain have been over the past
Total score ranges from 0-16 points
Combined Score of up to 36 points
1) O Leary MP et al. Urology 1997; 49: 58.
LEADERSHIP: AQX-1125 Significantly Reduced BPIC/SS at 6 Wks
Change from Baseline BPIC-SS Mean (SE)
0 -.3.7 -8.5 *p=0.012 Placebo AQX-1125
1) Humphrey et al. European Urology, Volume 61, Issue 2, Pages 271-279.
Symptom Scale (BPIC-SS)
Developed and validated
as a screening tool1
Bladder Pain IC Symptom Scale
8 questions about urinary
symptoms and bladder pain
over the past 7 days
Total Score up to 38 points
LEADERSHIP: 24-Hour Voiding Frequency at 6 Weeks
Change in Voiding Frequency Mean (SE)
-8 -6 -4 -2 0 Placebo AQX-1125
AQX-1125 trend in decreased urinary
LEADERSHIP: Greater Reductions in Pain and Symptoms of BPS/IC
Change in Average Daily Pain (eDiary) Change in Average Pain (Clinic) Change in Maximum Daily Pain (eDiary)