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Table 2 Parasite clearance kinetics (mITT population)

From: Randomized, open-label, phase 2a study to evaluate the contribution of artefenomel to the clinical and parasiticidal activity of artefenomel plus ferroquine in African patients with uncomplicated Plasmodium falciparum malaria

Endpoint

Ferroquine 400 mg

(N = 35)

Ferroquine 400 mg plus artefenomel

300 mg (N = 36)

600 mg (N = 36)

1000 mg (N = 33)

Parasite clearance rate (1/h)

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

0.20 (0.08)

[0.10 to 0.39]

0.36 (0.10)

[0.17 to 0.67]

0.40 (0.12)

[0.22 to 0.79]

0.36 (0.12)

[0.07 to 0.60]

Estimated PRR24, log10

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

2.0 (0.79)

[1.00 to 4.09]

3.76 (1.04)

[1.74 to 6.97]

4.13 (1.25)

[2.29 to 8.23]

3.73 (1.30)

[0.70 to 6.30]

Estimated PRR48, log10

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

4.08 (1.59)

[1.99 to 8.18]

7.52 (2.08)

[3.48 to 13.94]

8.26 (2.50)

[4.57 to 16.46]

7.46 (2.60)

[1.41 to 12.60]

Estimated PRR72, log10

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

6.12 (2.38)

[2.99 to 12.27]

11.28 (3.12)

[5.22 to 20.90]

12.39 (3.75)

[6.86 to 24.69]

11.20 (3.90)

[2.11 to 18.90]

PC50, h

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

14.07 (5.60)

[6.9 to 25.3]

7.74 (4.64)

[0.4 to 19.9]

7.78 (3.79)

[0.5 to 15.0]

9.47 (7.98)

[0.4 to 33.3]

TPC50, h

n = 21

n = 28

n = 28

n = 25

Geometric mean point estimate (95% CI)

3.79 (3.29, 4.38)

1.99 (1.75, 2.25)

1.81 (1.60, 2.05)

2.09 (1.84, 2.39)

PC99, h

n = 21

n = 28

n = 28

n = 25

Mean (SD)

[range]

36.92 (9.99)

[24.6 to 56.0]

19.33 (6.11)

[6.6 to 33.1]

18.34 (5.52)

[5.6 to 29.4]

22.95 (17.07)

[6.9 to 90.1]

TPC99, h

n = 21

n = 28

n = 28

n = 25

Geometric mean point estimate (95% CI)

25.21 (21.84, 29.10)

13.20 (11.66, 14.94)

12.05 (10.64, 13.65)

13.91 (12.20, 15.87)

  1. PRR parasite reduction ratio
  2. PC50 and PC99 were the time taken for parasitaemia to reduce by 50% and 99% from baseline parasitaemia, respectively, based on the linear model fitted to the linear part of the profile; TPC50 and TPC99 were the time taken for parasitaemia to reduce by 50% and 99%, respectively, based upon the parasite clearance rate, independent of the initial parasitaemia. PC50 PC99 and the parasite clearance rate were estimated using the WWARN PCE based upon the linear part of the individual natural log parasitaemia–time profiles. Data from patients with a poor fit to the linear model (r2 < 0.75) were excluded from the analysis