Novartis Gets CDSCO Panel nod to study antimalarial drug KLU156 with Coartem
New Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of antimalarial drug KLU156 with Coartem.
This came after the drug major Novartis presented Phase III clinical trial protocol No. CKLU156A12301.
This study aims to confirm the efficacy, safety, and tolerability of KLU156, a fixed dose combination of ganaplacide (KAF156) and a solid dispersion formulation of lumefantrine (lumefantrine-SDF) when administered once daily for three days in adults and children ≥ 5 kg body weight and ≥ 2 months of age suffering from uncomplicated P. falciparum malaria (with or without other Plasmodium spp. co-infection).
In the Extension phase, the safety, tolerability, and efficacy of repeated treatment with KLU156 will be assessed for a maximum of two years in patients who did not experience early treatment failure (ETF), who did not experience any study treatment-related SAE (Serious Adverse Event) previously and who gave informed consent to participate in the Extension phase.
Ganaplacide is a drug in development by Novartis for the purpose of treating malaria. It belongs to the class of the imidazolopiperazines. It has shown activity against the Plasmodium falciparum and Plasmodium vivax forms of the malaria parasite.
Lumefantrine is an antimalarial agent used in combination with artemether for the treatment of acute uncomplicated malaria caused by Plasmodium falciparum.
The exact mechanism by which lumefantrine exerts its antimalarial effect is unknown. However, available data suggest that lumefantrine inhibits the formation of β-hematin by forming a complex with hemin and inhibits nucleic acid and protein synthesis.
At the recent SEC meeting for Antimicrobial and Antiviral held on 21st December 2023, the expert panel reviewed the Phase III clinical trial protocol No. CKLU156A12301 presented by Novartis.
After detailed deliberation, the committee recommended the grant of permission to conduct the clinical trial as presented by the firm.
