Vanda Pharmaceuticals' Interim Analysis from ODYSSEY Study Shows Tradipitant may Accelerate Clinical Improvement in Patients with COVID-19 Pneumonia
- Interim analysis of the ODYSSEY study showed that a 14 day tradipitant treatment accelerated clinical improvement by day 7 (HR=2.55, p=0.0375)
- Tradipitant numerically improved median time to clinical improvement by day 28 (HR=1.55, p=0.2254)
- Similar overall rates of improvement and mortality were observed for the two treatment arms at day 28
- The interim analysis of the ODYSSEY study demonstrated that hospitalized patients with COVID-19 pneumonia?improved sooner when treated with tradipitant as compared to placebo.?This finding was based on a preliminary analysis of the first 60 patients enrolled in the ODYSSEY study of tradipitant in COVID-19 pneumonia.?ODYSSEY is an ongoing Phase III double-blind placebo-controlled trial investigating the efficacy and safety of?tradipitant, a neurokinin-1 receptor (NK-1R) antagonist, in the treatment of neurogenic inflammation of the lung secondary to SARS-CoV-2 (COVID-19) infection, which was initiated in April 2020.?The study is expected to enroll 300 patients, and as of?July 15, 2020, 60 patients had enrolled and completed the study. Because this is the first study of tradipitant for this indication and given the increased rate of mortality seen with COVID-19 pneumonia, an interim analysis was planned to better assess the efficacy and safety of tradipitant in this population of COVID-19 patients.
In the ODYSSEY study, clinical status was assessed on a 7 point scale ranging from death, to mechanical ventilation, various levels of oxygen requirements, to hospital discharge. Clinical improvement was defined as at least a 2 point improvement in the 7 point ordinal scale.
- Interim analysis in the first 60 enrolled patients showed that similar?percentages of patients improved between the two treatment arms, 57% for tradipitant and 50% for placebo. The mortality rate was also similar between the treatment groups with 14.2% for tradipitant and 16.6% for placebo.
- In the time to improvement analysis, after 7 days of treatment, patients treated with tradipitant recovered earlier than those receiving?placebo, which was statistically significant (HR=2.55, p=0.0375). This benefit was generally consistent among patients of varying degree of severity at baseline. At day 28 of the study, tradipitant showed a numerical benefit over placebo with an earlier median time to recovery (HR=1.55, p=0.2254, median time to improvement 10 days for tradipitant and 28 days for placebo).
Table 1.? Baseline Demographic Summary. Intention-to-Treat Population
Characteristic
Tradipitant?
Placebo
Total
?Statistic
(N= 28)
(N= 30)?
(N= 58)
Age (years)
71.0 (62.5 - 77.5)
66.5 (58.0 - 72.0)
68.5 (61.0 - 77.0)
Sex, n (%)
?Male
20 ( 71.4)
20 ( 66.7)
40 ( 69.0)
?Female
8 ( 28.6)
10 ( 33.3)
18 ( 31.0)
Any Comorbidities, n (%)
27 ( 96.4)
28 ( 93.3)
55 ( 94.8)
?Hypertension
11 ( 39.3)
15 ( 50.0)
26 ( 44.8)
?Diabetes
8 ( 28.6)
7 ( 23.3)
15 ( 25.9)
?Coronary Heart Disease
1 ( ?3.6)
4 ( 13.3)
5 ( ?8.6)
?Asthma
1 ( ?3.6)
4 ( 13.3)
5 ( ?8.6)
7 Point Ordinal Scale at Baseline, n (%)
?2 - Hospitalized on mechanical ventilation or ECMO
4 ( 14.3)
2 ( ?6.7)
6 ( 10.3)
?3 - Hospitalized on non-invasive ventilation or high-flow oxygen supplement
13 ( 46.4)
12 ( 40.0)
25 ( 43.1)
?4 - Hospitalized requiring supplemental oxygen
9 ( 32.1)
16 ( 53.3)
25 ( 43.1)
?5 - Hospitalized not requiring supplemental oxygen, requiring continued?medical care
2 ( ?7.1)
0 ( ?0.0)
2 ( ?3.4)
Time from Hospitalization to Starting Study Treatment, Days?
4.0 (2.0 - 6.5)
6.0 (2.0 - 12.0)
4.0 (2.0 - 9.0)
?Early (<=10 Days from Hospitalization)
23 ( 82.1)
22 ( 73.3)
45 ( 77.6)
?Late (>10 Days from Hospitalization)
5 ( 17.9)
8 ( 26.7)
13 ( 22.4)
Highest Oxygen Therapy Support , n (%)
?Room Air
1 ( ?3.6)
0 ( ?0.0)
1 ( ?1.7)
?Nasal Cannula (NC)
5 ( 17.9)
6 ( 20.0)
11 ( 19.0)
?Non Rebreather (NRB)
1 ( ?3.6)
2 ( ?6.7)
3 ( ?5.2)
?High Flow Nasal Cannula (HFNC)
6 ( 21.4)
9 ( 30.0)
15 ( 25.9)
?CPAP Mask
0 ( ?0.0)
2 ( ?6.7)
2 ( ?3.4)
?BiPAP Mask
1 ( ?3.6)
1 ( ?3.3)
2 ( ?3.4)
?Mechanical Ventilation
14 ( 50.0)
10 ( 33.3)
24 ( 41.4)
% = 100 x n/N. Data are median (IQR).
Table 2.? Outcomes Overall and According to Score on the Ordinal Scale at Day 7. Intention-to-Treat Population
?Overall*
Ordinal Score at Baseline*
4
3
2
Tradipitant
Placebo
Tradipitant
Placebo
Tradipitant
Placebo
Tradipitant
Placebo
(N= 28)
(N= 30)
(N=? 9)
(N= 16)
(N= 13)
(N= 12)
(N=? 4)
(N=? 2)
Responder as Improvement of 2 or More Points
?? No. of responders
13
7
6
6
2
1
3
0
?? Median time to responder
. (4-NE)
. (NE-NE)
4 (3-NE)
. (4-NE)
. (5-NE)
. (NE-NE)
4 (2-NE)
. (NE-NE)
?????(95% CI) ? days
?? Hazard ratio (95% CI)**
2.55 (1.02-6.42 [0.0461])
?2.23 (0.71-6.98 [0.1673])
2.19 (0.20-24.18 [0.5225])
NE (0.00-NE [0.9983])
Mortality
?? Hazard ratio (95% CI)?
2.65 (0.24-29.29 [0.4255])
?3.14 (0.20-50.23 [0.4186])
. (NE - NE [NE])
NE (0.00-NE [0.9985])
?? No. of deaths by day 7
2
1
1
1
0
0
1
0
?? KM estimate ? %
9.8
3.8
25.0
8.3
0.0
0.0
25.0
0.0
???? (95% CI)
(2.5-33.8)
(0.6-24.3)
(3.9-87.2)<
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