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Last Updated: January 20, 2025

Investigational Drug Information for KAF156


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What is the drug development status for KAF156?

KAF156 is an investigational drug.

There have been 8 clinical trials for KAF156. The most recent clinical trial was a Phase 2 trial, which was initiated on September 11th 2023.

The most common disease conditions in clinical trials are Malaria, Malaria, Falciparum, and Malaria, Vivax. The leading clinical trial sponsors are Novartis Pharmaceuticals, Medicines for Malaria Venture, and European and Developing Countries Clinical Trials Partnership (EDCTP).

There are three US patents protecting this investigational drug and forty-five international patents.

Recent Clinical Trials for KAF156
TitleSponsorPhase
Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum MalariaMMV, EDCTP, WANECAMPhase 3
Efficacy, Safety and Tolerability of KLU156 in Adults and Children ≥ 5 kg Body Weight With Uncomplicated P. Falciparum MalariaNovartis PharmaceuticalsPhase 3
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With EfavirenzMedicines for Malaria VenturePhase 1

See all KAF156 clinical trials

Clinical Trial Summary for KAF156

Top disease conditions for KAF156
trials012345678MalariaMalaria, FalciparumMalaria, VivaxBody Weight[disabled in preview]
Top clinical trial sponsors for KAF156
trials012345678Novartis PharmaceuticalsMedicines for Malaria VentureEuropean and Developing Countries Clinical Trials Partnership (EDCTP)[disabled in preview]

See all KAF156 clinical trials

US Patents for KAF156

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
KAF156 ⤷  Subscribe Compounds and compositions useful for the treatment of parasitic diseases IRM LLC (Hamilton, BM) ⤷  Subscribe
KAF156 ⤷  Subscribe Compounds and compositions for the treatment of parasitic diseases Novartis AG (Basel, CH) ⤷  Subscribe
KAF156 ⤷  Subscribe Compounds and compositions for the treatment of parasitic disease Novartis AG (Basel, CH) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 3 of 3 entries

International Patents for KAF156

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
KAF156 Argentina AR077463 2029-07-09 ⤷  Subscribe
KAF156 Australia AU2010271247 2029-07-09 ⤷  Subscribe
KAF156 Brazil BR112012000413 2029-07-09 ⤷  Subscribe
KAF156 Canada CA2767664 2029-07-09 ⤷  Subscribe
KAF156 Chile CL2012000042 2029-07-09 ⤷  Subscribe
KAF156 China CN102471341 2029-07-09 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 6 of 6 entries

Development Update and Market Projection for KAF156: A Novel Antimalarial Drug Candidate

Introduction to KAF156

KAF156, also known as GNF-156, is a groundbreaking antimalarial drug candidate developed by Novartis in collaboration with Medicines for Malaria Venture (MMV) and supported by the Bill & Melinda Gates Foundation. This drug belongs to the novel class of antimalarials known as imidazolopiperazines, which holds significant promise in combating drug-resistant strains of malaria.

Mechanism and Potential

KAF156 has been designed to target multiple stages of the malaria parasite's lifecycle, including both Plasmodium falciparum and Plasmodium vivax. It has shown rapid and potent efficacy in clearing malaria infections, including those resistant to current therapies. The drug's unique mechanism of action differentiates it from existing antimalarials, making it a potential game-changer in the fight against malaria[1][4].

Clinical Trials

The clinical development of KAF156 is ongoing, with a focus on its combination with a new, improved formulation of lumefantrine known as Solid Dispersion Formulation (LUM-SDF). This combination is expected to be fast-acting, fully curative, and improve patient adherence by allowing once-daily dosing instead of the traditional twice-daily regimen[1][4].

  • Phase IIb Trials: The phase IIb clinical trials, initiated in August 2017, are being conducted across nine countries in Africa and Asia. These trials aim to test multiple dosing combinations and schedules, including the feasibility of a single-dose therapy in adults, adolescents, and children. The trials are particularly complex due to the simultaneous testing of various dosing regimens in different age groups[1][4].

  • Expansion to Pediatric Populations: Following safety reviews of the data generated in adults, the trials are planned to expand to include adolescents and children, who are the most vulnerable to malaria. This rapid inclusion of pediatric populations is crucial for accelerating the development of a pediatric formulation[1].

Safety, Efficacy, and Transmission Blocking Properties

The clinical trial program is designed to assess not only the safety and efficacy of KAF156 combined with LUM-SDF but also its transmission-blocking properties. This is critical in regions where malaria remains a major public health concern, such as West and Central Africa, which account for nearly two-thirds of the morbidity and mortality attributed to Plasmodium falciparum malaria[4].

Market Projection and Global Impact

Market Size and Growth

The global malaria treatment market is projected to experience significant growth, driven by the increasing incidence of malaria and the need for new, effective treatments. The market is estimated to reach $24.48 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 28.5% from 2022 to 2030[5].

Competitive Landscape

KAF156 is one of the leading candidates in the antimalarial drug development pipeline. Novartis's commitment to delivering antimalarial treatments, including the recent milestone of delivering 1 billion courses of antimalarial treatment since 1999, underscores the company's role in the global fight against malaria. The introduction of KAF156 is expected to further strengthen Novartis's position in the market[5].

Regional Impact

The Middle East and Africa currently hold the largest share of the malaria treatment market, with countries like Nigeria, Ghana, Uganda, Angola, and Cameroon being major contributors. However, the Asia Pacific region is anticipated to register the highest CAGR during the forecast period, driven by initiatives such as India's significant reduction in malaria morbidity and mortality between 2000 and 2019[5].

Challenges and Future Directions

Resistance to Current Therapies

The emergence of resistance to artemisinin and many partner drugs in current antimalarial therapies is a significant challenge. KAF156's novel mechanism of action addresses this issue, providing a new tool in the fight against drug-resistant malaria strains[1][4].

Regulatory and Developmental Hurdles

The development of KAF156 is subject to various uncertainties, including clinical trial results, regulatory approvals, and intellectual property protection. However, the collaborative efforts between Novartis, MMV, and other stakeholders are aimed at overcoming these hurdles and ensuring the timely registration of KAF156 through stringent regulatory health authorities[1].

Capacity Building and Networking

The clinical development of KAF156 is part of a broader initiative to enhance biomedical research capacity, particularly in underrepresented countries in Africa. This includes training young scientists and improving targeted capacities and infrastructure, which will be crucial for the long-term success of antimalarial drug development and deployment[4].

Key Takeaways

  • Novel Mechanism: KAF156 belongs to the imidazolopiperazines class, offering a new mechanism of action against malaria.
  • Clinical Trials: Ongoing phase IIb trials are testing KAF156 in combination with LUM-SDF across multiple age groups and regions.
  • Market Growth: The global malaria treatment market is projected to grow significantly, with KAF156 expected to play a key role.
  • Addressing Resistance: KAF156 addresses the rising issue of resistance to current antimalarial therapies.
  • Capacity Building: The development process includes enhancing biomedical research capacity, especially in Africa.

FAQs

What is KAF156 and how does it differ from existing antimalarials?

KAF156 is a novel antimalarial drug candidate belonging to the imidazolopiperazines class. It differs from existing antimalarials through its unique mechanism of action, which targets multiple stages of the malaria parasite's lifecycle and is effective against drug-resistant strains.

Where are the clinical trials for KAF156 being conducted?

The clinical trials for KAF156 are being conducted across nine countries in Africa and Asia, including Mali, Burkina Faso, Gabon, India, Kenya, Mozambique, Thailand, Uganda, and Vietnam.

What is the expected market impact of KAF156?

KAF156 is expected to significantly impact the global malaria treatment market, which is projected to reach $24.48 billion by 2030. The drug's introduction will help address the growing need for effective treatments against drug-resistant malaria.

How does KAF156 address the issue of resistance to current therapies?

KAF156's novel mechanism of action makes it effective against malaria strains resistant to current therapies, including artemisinin and its partner drugs. This addresses a critical need in regions where resistance is a major public health concern.

What are the next steps in the development of KAF156?

Following the completion of phase IIb trials, the next steps will include phase III trials, regulatory approvals, and the registration of KAF156 through stringent health authorities. This will pave the way for its market approval and distribution.

Sources

  1. Novartis and Medicines for Malaria Venture launch patient trial in Africa for KAF156, a novel compound against multidrug-resistant malaria. Novartis. August 21, 2017.
  2. Ganaplacide - Drug Targets, Indications, Patents. Patsnap Synapse.
  3. New drugs could offer hope for malaria patients. Novartis. July 31, 2014.
  4. A phase 2 and 3 clinical trial program to assess safety, efficacy and transmission blocking properties of the new anti-Malarial KAF156 combined with a new formulation of lumefantrine in children and adults with uncomplicated Plasmodium sp. Malaria in West and Central Africa. ERA-LEARN. March 1, 2019.
  5. Malaria Treatment Market Size to Hit 28.5% CAGR, Globally, by 2030. GlobeNewswire. November 3, 2023.

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