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SEC allows waiver of two conditions for clinical study of Novartis’ anti malarial drug Cipargamin

Gireesh Babu, New Delhi
Thursday, October 7, 2021, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) has waived two of its four conditions recommended earlier to Novartis related to its phase II study on synthetic anti malarial drug Cipargamin.  The decision comes after the company presented its justification for the waiver of the conditions.

The company, in October, last year, through online submitted its proposal for Phase II study protocol explaining that Cipargamin, also known as KAE 609, is a novel spiroindolone class drug with potent and fast-acting schizonticidal activity.

Severe malaria is a medical emergency in malaria endemic countries. With currently one World Health Organisation (WHO) recommended IV treatment, there is considerable medical need for an additional treatment option, it said. The proposed study is to investigate the efficacy (parasite reduction and clinical outcome), safety, tolerability and pharmacokinetics of different injectable dose regiments of the drug in comparison to injectable artesunate.

The Committee, in its meeting on July 27, 2021, considered the application and recommended for grant of permission to conduct the study with conditions including that the age group for the Cohort-1 should be from 18 years to 65 years of age. The age group for Cohort-2 should be from 12 to 18 years of age.

The firm should also include the test of haemoglobin in plasma and haemoglobin in urine in its routine analysis. The firm should submit the safety and efficacy data from the Cohort 1 and Cohort 2 before the committee and after review of the same the Cohort 3 to 5 study should be initiated.

However, in the latest meeting, on antimicrobial and antiviral drugs, held on September 23 and 24, the Committee observed that in the light of the earlier recommendation on July 27, the firm presented their justification for the waiver of the conditions before the committee.

After detailed deliberation, the committee recommended waiver of the first two conditions, related to the Cohort 1 and 2, of the clinical trial permission.

According to a company announcement in May, this year, KAE609 is one of the three compounds it is developing against artemisinin-resistant strains of malaria disease.

Cipargamin is a novel antimalarial compound demonstrating rapid clearance of parasites pre-clinically and in patients. Novartis is leading the development of the drug with financial support from the Wellcome Trust and in collaboration with the PAMAFRICA Research Consortium supported by the European & Developing Countries Clinical Trials Partnership (EDCTP) led by Medicines for Malaria Venture (MMV).

KAF156 (ganaplacide), another drug under development, belongs to a novel class of antimalarial compounds that act against both the blood and liver stages of the parasite's life cycle. It demonstrated activity against both P. vivax and P. falciparum malaria, including artemisinin-resistant parasites. Novartis leads the development of this compound with scientific and financial support from MMV and from EDCTP via the WANECAM2 Consortium.

In 2020, the company discovered another novel malaria compound, INE963, which has an entirely new mechanism of action which is expected to begin clinical trials in 2021. INE963 is a fast-acting, long-lasting antimalarial which holds promise for a high barrier to resistance. It was discovered with support from MMV.

The company announced that by May, this year, it has delivered one billion courses of anti malarial treatment since 1999, and more than 90 per cent of this artemisinin-based combination therapy (ACT) was supplied without profit to malaria-endemic countries around the globe.


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