BELLUS Health Announces Topline Results from its Phase 2 RELIEF Trial of BLU-5937 for the Treatment of Refractory Chronic Cough

Nachrichtenquelle: Business Wire (engl.)
06.07.2020, 13:00  |  769   |   |   

BELLUS Health Inc. (Nasdaq: BLU; TSX: BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced topline results from its Phase 2 RELIEF trial of BLU-5937 in patients with refractory chronic cough.

The Phase 2 RELIEF trial of BLU-5937 did not achieve statistical significance for the primary endpoint of reduction in placebo-adjusted cough frequency at any dose tested. A clinically meaningful and highly statistically significant placebo-adjusted reduction in cough frequency was achieved in a pre-specified sub-group of high cough count patients (all patients at or above the baseline median average of 32.4 coughs per hour).

All patients (n=62)

Dose

Placebo-adjusted
reduction in awake
cough frequency

P-value

25mg BID

-11%

p=0.14

50mg BID

-6%

p=0.46

100mg BID

-8%

p=0.41

200mg BID

-17%

p=0.09

Patients with awake cough frequency at or above baseline median (≥32.4 cough/hr; n=31)

Dose

Placebo-adjusted
reduction in awake
cough frequency

P-value

25mg BID

-28%

p=0.0005

50mg BID

-28%

p=0.0003

100mg BID

-30%

p=0.0014

200mg BID

-32%

p=0.0006

BLU-5937 was also observed to be well tolerated with no serious adverse events reported and no withdrawals due to treatment-related adverse events at any dose. Taste effects, including taste alteration and partial taste loss, were infrequent at all dose levels (6.5%, 9.8%, 10% and 8.6% at 25mg BID, 50mg BID, 100mg BID and 200mg BID, respectively, versus 4.9% on placebo) and mostly mild in nature. No patients reported complete taste loss. There were no clinically meaningful changes in vital signs, electrocardiogram or clinical laboratory values.

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