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Last Updated: January 20, 2025

Investigational Drug Information for KAE609


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What is the development status for investigational drug KAE609?

KAE609 is an investigational drug.

There have been 8 clinical trials for KAE609. The most recent clinical trial was a Phase 2 trial, which was initiated on January 1st 2012.

The most common disease conditions in clinical trials are Malaria, Malaria, Falciparum, and Malaria, Vivax. The leading clinical trial sponsors are Novartis Pharmaceuticals, Wellcome Trust, and EDCTP within the PAMAFRICA Grant.

Recent Clinical Trials for KAE609
TitleSponsorPhase
Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum MalariaNovartis PharmaceuticalsPhase 2
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum MalariaEDCTP within the PAMAFRICA GrantPhase 2
To Evaluate Efficacy, Safety, Tolerability and PK of Intravenous Cipargamin in Participants With Severe Plasmodium Falciparum MalariaEuropean and Developing Countries Clinical Trials Partnership (EDCTP)Phase 2

See all KAE609 clinical trials

Clinical Trial Summary for KAE609

Top disease conditions for KAE609
trials012345678MalariaMalaria, FalciparumMalaria, Vivax[disabled in preview]
Top clinical trial sponsors for KAE609
trials012345678Novartis PharmaceuticalsWellcome TrustEDCTP within the PAMAFRICA Grant[disabled in preview]

See all KAE609 clinical trials

KAE609 (Cipargamin): A Promising Antimalarial Drug Candidate

Introduction

Malaria, a life-threatening mosquito-borne disease caused by Plasmodium parasites, continues to be a significant global health issue. The emergence of drug-resistant strains of the parasite has necessitated the development of new and effective antimalarial drugs. One such promising candidate is KAE609, also known as cipargamin, a novel spiroindolone compound.

Mechanism of Action and Pharmacodynamic Effects

KAE609 belongs to the spiroindolone class of compounds, identified through a phenotypic screen for their antimalarial activity. The exact mechanism of action of cipargamin is not fully understood, but it is believed to target the Plasmodium non-SERCA-type Ca2+-transporting P-ATPase (PfATP4). Mutations in PfATP4 confer resistance to this compound, suggesting its role in regulating Na+ homeostasis and maintaining the low cytosolic Na+ concentration essential for the parasite's survival during the intraerythrocytic stages of development[1][4].

Clinical Development

Cipargamin is currently in Phase 2 clinical development, with several trials completed to assess its safety and efficacy in patients with uncomplicated P. falciparum or P. vivax malaria.

  • Phase 2 Trials: Multiple Phase 2 trials have been conducted, including studies to assess the minimum inhibitory concentration, efficacy, safety, tolerability, and pharmacokinetics of KAE609. For example, the trial NCT01524341 reported rapid parasitemia clearance in adults with uncomplicated P. falciparum or P. vivax malaria[1][4].
  • Combination Therapy: Evaluations have also been conducted to assess the potential of piperaquine as a combination therapy partner with cipargamin, showing no significant effect on exposure to either compound and no safety concerns[1].
  • Severe Malaria: A Phase 2 trial (NCT04675931) is ongoing to evaluate the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin in participants with severe P. falciparum malaria[1].

Market Projections

The development and potential approval of KAE609 are expected to significantly impact the malaria treatment market.

North America Malaria Treatment Market

  • The North America malaria treatment market is projected to grow at a CAGR of 29.1% from 2022 to 2030, reaching US$ 487.31 million by 2030. The growing pipeline of new drugs and vaccines, including cipargamin, is a key driver of this growth[2].
  • The vaccines segment, which includes potential future approvals of new antimalarial drugs, held a significant share of the market in 2022 and is expected to continue growing[2].

Europe Malaria Treatment Market

  • The Europe malaria treatment market is valued at US$ 451.69 million in 2022 and is expected to reach US$ 3,060.97 million by 2030, growing at a CAGR of 27.0%. The increasing number of antimalarial drugs and vaccines in clinical development, such as KAE609, is anticipated to boost market growth[5].

Challenges and Opportunities

Drug Resistance

One of the major challenges in the development and use of antimalarial drugs is the emergence of drug-resistant strains. Cipargamin's novel mechanism of action targeting PfATP4 offers hope in combating resistance, but continuous monitoring for resistance is crucial[1][3].

Market Growth Drivers

  • Innovative Therapies: The development of new antimalarial compounds like cipargamin is driving market growth. These innovative therapies are expected to improve treatment outcomes and reduce the burden of malaria[2][5].
  • Strategic Initiatives: Collaborations between pharmaceutical companies, research institutions, and public health organizations are facilitating the development and distribution of new antimalarial drugs, including cipargamin[2][5].

Market Hurdles

  • Counterfeit Drugs: The availability of counterfeit antimalarial drugs poses a significant challenge to the market, as it can lead to drug resistance and undermine the effectiveness of genuine treatments[2].
  • Regulatory Approvals: The regulatory approval process for new drugs can be lengthy and complex, which may delay the market entry of promising candidates like cipargamin[4].

Conclusion

KAE609 (cipargamin) represents a promising advancement in the fight against malaria, with its unique mechanism of action and positive clinical trial results. As the drug progresses through clinical development, it is expected to play a significant role in the growing malaria treatment market in both North America and Europe.

Key Takeaways

  • Novel Mechanism: Cipargamin targets PfATP4, a novel target for antimalarial therapy.
  • Clinical Development: The drug is in Phase 2 clinical trials, showing promising safety and efficacy results.
  • Market Impact: The approval of cipargamin is expected to drive growth in the malaria treatment market.
  • Challenges: Drug resistance and counterfeit drugs remain significant challenges.
  • Opportunities: Collaborative efforts and innovative therapies are driving market growth.

FAQs

1. What is the current stage of clinical development for KAE609? KAE609 is currently in Phase 2 clinical development, with several trials assessing its safety, efficacy, and pharmacokinetics in patients with uncomplicated P. falciparum or P. vivax malaria.

2. How does KAE609 differ from existing antimalarial drugs? KAE609 targets the Plasmodium non-SERCA-type Ca2+-transporting P-ATPase (PfATP4), a novel mechanism of action distinct from existing antimalarial drugs.

3. What are the potential market impacts of KAE609 approval? The approval of KAE609 is expected to drive significant growth in the malaria treatment market, particularly in North America and Europe, due to its innovative therapy and potential to combat drug-resistant strains.

4. What are the main challenges facing the development and use of KAE609? The main challenges include the emergence of drug-resistant strains and the availability of counterfeit antimalarial drugs, which can undermine the effectiveness of genuine treatments.

5. Which companies are involved in the development of KAE609? KAE609 is being developed by Novartis AG, in collaboration with various research institutions and public health organizations.

Sources

  1. IUPHAR/BPS Guide to PHARMACOLOGY: Cipargamin | Ligand page | IUPHAR/BPS Guide to PHARMACOLOGY.
  2. Business Market Insights: North America Malaria Treatment Market Forecast to 2030.
  3. EXCLI Journal: A scoping review of antimalarial drug candidates in phase I and II drug development.
  4. ScienceDirect: The early preclinical and clinical development of cipargamin (KAE609), a novel antimalarial compound.
  5. Business Market Insights: Europe Malaria Treatment Market to 2030.

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