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A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.
The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.
“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.
“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”
For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.
The researchers found that asexual parasites were cleared by day 7 in both treatment groups.
In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).
In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).
Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.
The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).
Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.
The researchers hope to expand testing of AQ-13 to more participants, including women and children.
Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.
“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.” 
A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.
The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.
“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.
“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”
For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.
The researchers found that asexual parasites were cleared by day 7 in both treatment groups.
In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).
In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).
Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.
The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).
Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.
The researchers hope to expand testing of AQ-13 to more participants, including women and children.
Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.
“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”
A new drug is effective against non-severe cases of malaria, according to results from a phase 2 trial published in The Lancet Infectious Diseases.
The drug, AQ-13, was able to clear patients of the malaria parasite Plasmodium falciparum within a week, matching the effectiveness of combination treatment with artemether and lumefantrine.
“The clinical trial results are extraordinarily encouraging,” said study author Donald Krogstad, MD, of Tulane University in New Orleans, Louisiana.
“Compared to the current first-line recommendation for treatment of malaria, the new drug comes out very well.”
For this study, Dr Krogstad and his colleagues recruited 66 adult men in Mali with uncomplicated malaria. Half of the subjects were randomized to receive AQ-13, and the other half received combination treatment with artemether and lumefantrine.
The researchers found that asexual parasites were cleared by day 7 in both treatment groups.
In a per-protocol analysis, the cure rate was 100% (28/28) in the AQ-13 group and 93.9% (28/31) in the combination group (P=0.50, difference −6.1%, 95% CI −14.7 to 2.4).
In the intention-to-treat analysis, the cure rate was 84.8% (28/33) in the AQ-13 group and 93.9% in the combination group (P=0.43, difference 9.1%, 95% CI −5.6 to 23.8).
Grade 1 or lower adverse events (AEs) occurred in 239 patients in the AQ-13 group and 214 in the combination group. There were no grade 2-4 AEs.
The most common AEs (in the AQ-13 and combination groups, respectively) were fever (97% and 88%), weakness (82% and 85%), myalgias and arthralgias (82% and 76%), headache (97% and 94%), and anorexia (73% and 61%).
Two subjects in AQ-13 group left the study, and 3 were lost to follow-up. Two subjects in the combination group had late treatment failures with recurrence of their original infections.
The researchers hope to expand testing of AQ-13 to more participants, including women and children.
Dr Krogstad said the same biotechnology that helped the researchers develop AQ-13 has also revealed similar drugs that hold promise against drug-resistant parasites.
“The potential long-term implications are bigger than one drug,” Dr Krogstad said. “The conceptual step here is that if you understand the resistance well enough, you may actually be able to develop others as well. We synthesized over 200 analogues and, of those, 66 worked against the resistant parasites.”