For the treatment of thrombocytopenia in adult patients with chronic liver disease before a scheduled procedure

DOPTELET Delivered Consistent Efficacy in 2 Robust Phase III Studies

ADAPT-1 and ADAPT-2 Were 2 Identically Designed, Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies (N=435)1

ADAPT-1 and ADAPT-2 Phase III study design to evaluate the efficacy and safety of DOPTELET
  • Primary Endpoint:
    • Patients not requiring a platelet transfusion or any rescue procedure for bleeding up to 7 days following a scheduled procedure1
  • Secondary Endpoints:
    • Proportion of patients achieving a platelet count ≥50,000/µL on day of procedure1
    • Mean change in platelet count from baseline to day of procedure1

Significantly More Patients Achieved a Platelet Count of 50,000/µL With DOPTELET1

Up to 93% of high-baseline patients and 69% of low-baseline patients reached the
50,000/µL target (N=435).1

DOPTELET vs placebo in the High Baseline group: 88% vs 21% and 93% vs 39% (p<.0001); DOPTELET vs placebo in the Low Baseline group: 69% vs 4% and 67% vs 7% (p<.0001)

^Percent of patients achieving a platelet count ≥50,000/μL on day of procedure.1

Significantly Reduced the Need for Platelet Transfusion or Any Rescue Procedure for Bleeding†1

88% of high-baseline patients and up to 69% of low-baseline patients taking DOPTELET achieved the primary endpoint (N=435).1

DOPTELET vs placebo in the High Baseline group: 88% vs 38% and 88% vs 33% (p<.0001); DOPTELET vs placebo in the Low Baseline group: 66% vs 23% and 69% vs 35% (p<.0001 and p=.0006, respectively)

From randomization up to 7 days after a procedure compared to placebo.

Percent of patients not requiring a platelet transfusion or any rescue procedure for bleeding up to 7 days following a scheduled procedure.1

Platelet Count Increased By Procedure Day and Then Returned to Baseline1

Mean Change in Platelet Count: up to +45,000 in high-baseline patients and +32,000 in low-baseline patients1

Mean change in platelet count: up to +45,000 in high-baseline patients and +32,000 in low-baseline patients

§In patients with baseline platelet count of 10K to 20K (n=9), mean change in platelet count was 10K.2

97% of patients with a platelet count measured on procedure day had an increase with DOPTELET2

Mean Platelet Count Peaked After 10 to 13 Days and Returned to Near Baseline After 35 Days1

Platelet count increase observed within 3 to 5 days of start of DOPTELET

Increase Within 3 to 5 days

Onset of platelet count increase was observed within 3 to 5 days of start of 5-day
treatment course

Peak effect increase observed 10 to 13 days after start of DOPTELET

Peak Effect After 10 to 13 Days

Peak effect of increase was observed 10 to 13 days after start of treatment

Platelet count decreased gradually, returning to near baseline values after 35 days

Near Baseline After 35 Days

Platelet count decreased gradually, returning to near baseline values after 35 days

References:

1.    DOPTELET [package insert]. Durham, NC: Dova Pharmaceuticals, Inc.; 2018.

2.    Data on File. Dova Pharmaceuticals, Inc.