NCT02174978
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported
pharma · Breast Cancer · Prostate Cancer · UTHR
United Therapeutics Europe
United Therapeutics Europe Ltd
United Therapeutics is a pharma organization headquartered in Silver Spring, USA. It trades on NYSE under ticker UTHR. Primary therapeutic focus areas include Breast Cancer, Prostate Cancer, Pulmonary Arterial Hypertensi
1000 Spring Street, Silver Spring, Maryland 20910, US HQ
1996 Founded
1,443 Employees
Public company Type
UTHR · NYSE Ticker
Company details
- Status
- Public
- HQ
- 1000 Spring Street, Silver Spring, Maryland 20910, US
- Founded
- 1996
- Employees
- 1,443
- Programs
- 1032
- Drugs
- 612
- Patents
- 3720
FMP012 with AS01B adjuvant system
Phase 1 · mab · Malaria
FMP012 is a monoclonal antibody therapeutic candidate in development by United Therapeutics Europe Ltd for the treatment of malaria. The program combines FMP012 with the AS01B adjuvant system to enhance immune response. As of October 2017, the program has completed Phase 1 clinical evaluation (NCT02174978). The sponsor
Internal code S-14-02
At a glance
- Sponsor
- United Therapeutics Europe Ltd
- Phase
- Phase 1
- Modality
- mab
- Indication
- Malaria
- Status
- completed
- Trials
- 1
Executive summary
FMP012 is a monoclonal antibody therapeutic candidate in development by United Therapeutics Europe Ltd for the treatment of malaria. The program combines FMP012 with the AS01B adjuvant system to enhance immune response. As of October 2017, the program has completed Phase 1 clinical evaluation (NCT02174978). The sponsor's strategy appears focused on exploring novel immunological approaches to malaria prevention or treatment, positioning this antibody-based candidate alongside existing small-molecule antimalarial therapies. Current development status indicates Phase 1 completion, with no publicly disclosed information regarding advancement to Phase 2 or regulatory milestones. The program represents an exploratory approach within the malaria therapeutic space, where established small-molecule treatments dominate the approved landscape.
Why this program matters
Malaria remains a significant global health burden, particularly in sub-Saharan Africa and other endemic regions. While effective small-molecule antimalarials exist, including artemether-lumefantrine combinations and other established agents, the emergence of drug-resistant parasites and the need for improved preventive strategies create ongoing unmet medical needs. A monoclonal antibody approach to malaria represents a mechanistically distinct strategy from conventional small-molecule therapeutics, potentially offering novel benefits such as targeted immune enhancement or parasite neutralization. The competitive landscape includes approved agents (artemether-lumefantrine, sulfadoxine-pyrimethamine, chloroquine, artesunate-amodiaquine combinations) and emerging candidates like GSK's tafenoquine in Phase 3. FMP012 with AS01B targets a patient population encompassing both malaria-endemic regions and travelers requiring prophylaxis. Commercial significance depends on efficacy, safety, and regulatory approval outcomes, with potential market relevance contingent on differentiation from existing therapies and addressing specific unmet needs in prevention or treatment-resistant cases.
Drug intelligence
Drug Class: Monoclonal antibody (mAb) therapeutic
Modality: Monoclonal antibody
Adjuvant System: AS01B (proprietary adjuvant to enhance immunogenicity)
Indication: Malaria
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: Established antimalarials include artemether-lumefantrine combinations (Coartem), artesunate-amodiaquine, sulfadoxine-pyrimethamine, chloroquine, and primaquine. Emerging competitors include GSK's tafenoquine (Phase 3) and other combination therapies.
First Approval: Not applicable; program remains in clinical development
Patent Status: Not yet disclosed
malaria
Prevalence: Point prevalence: 1-9 / 100 000 (Europe) — source: Orphanet, validated.
Overview
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. Infection with malaria parasites may result in a wide variety of symptoms, ranging from absent or very mild symptoms to severe disease and even death. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. In general, malaria is a curable disease if diagnosed and treated promptly and correctly.Treatment depends on many factors including disease severity, the species of malaria parasite causing the infection and the part of the world in which the infection was acquired.
Treatment landscape
ClinicalTrials.gov lists 860 registered studies for Malaria (AACT aggregate).
Phase breakdown: NA (334), PHASE1 (158), PHASE4 (123), PHASE3 (108), PHASE2 (78), PHASE1/PHASE2 (41), PHASE2/PHASE3 (15), EARLY_PHASE1 (3)
Common investigational therapies:
- Placebo
- PfSPZ Vaccine
- Primaquine
- Artesunate
- Artemether-lumefantrine
- Chloroquine
- Artemether-lumefantrine combination
- dihydroartemisinin-piperaquine
- Amodiaquine
- PfSPZ Challenge
Disease data sourced from MONDO Disease Ontology (MONDO:0005136), Orphanet — malaria, NCT00001645, NCT00075049, NCT00111163, NCT00114010, NCT00115921, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 12017-10-13
Phase 1 Completion
FMP012 with AS01B adjuvant system completed Phase 1 clinical evaluation (NCT02174978).
Competitive landscape
The malaria therapeutic landscape includes multiple approved small-molecule agents: artemether-lumefantrine (Coartem), artesunate-amodiaquine combinations, sulfadoxine-pyrimethamine, chloroquine, and primaquine. These established therapies, attributed to United Therapeutics Europe Ltd in the facts, represent the standard of care for malaria treatment and prevention. Emerging competitors include GSK's tafenoquine, currently in Phase 3 development, which represents a novel small-molecule approach to malaria prophylaxis. Additional Phase 3 candidates include artemether-lumefantrine formulations under development by Avenue Therapeutics. FMP012 with AS01B represents a mechanistically distinct monoclonal antibody approach, potentially offering differentiation through targeted immune enhancement. However, the program's Phase 1 status places it significantly earlier in development than Phase 3 competitors. The competitive advantage of FMP012 remains contingent on disclosed mechanism of action, efficacy data, and regulatory outcomes. The crowded landscape of approved and advanced-stage antimalarials presents a substantial competitive barrier to market entry.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| artemether lumefantrine | United Therapeutics Europe Ltd | small_molecule | approved |
| AL (Coartem) | United Therapeutics Europe Ltd | small_molecule | approved |
| artemether-lumefantrine (ALN) | United Therapeutics Europe Ltd | small_molecule | approved |
| Sulfadoxine-pyrimethamine | United Therapeutics Europe Ltd | small_molecule | approved |
| Chloroquine | United Therapeutics Europe Ltd | small_molecule | approved |
| Coartem™ (Artemether-lumefantrine combination) | United Therapeutics Europe Ltd | small_molecule | approved |
| Artesunate-amodiaquine combination | United Therapeutics Europe Ltd | small_molecule | approved |
| primaquine | Repatha | small_molecule | approved |
| Amodiaquine plus Artesunate co-administration | United Therapeutics Europe Ltd | small_molecule | approved |
| Tafenoquine | GlaxoSmithKline | small_molecule | phase_3 |
| abamectin and fenpyroximate | United Therapeutics Europe Ltd | small_molecule | phase_3 |
| Artemether-lumefantrine | AVENUE THERAPEUTICS, INC. | small_molecule | phase_3 |
| QUINIDINE GLUCONATE | — | Sodium channel alpha subunit blocker | Approved |
| HYDROXYCHLOROQUINE SULFATE | — | Toll-like receptor 7 antagonist | Approved |
| HYDROXYCHLOROQUINE | — | Toll-like receptor 7 antagonist | Approved |
| DOXYCYCLINE | — | Matrix metalloproteinase 8 inhibitor | Approved |
| DEXAMETHASONE | — | Glucocorticoid receptor agonist | Phase 3 |
| CYTARABINE | — | DNA polymerase (alpha/delta/epsilon) inhibitor | Phase 3 |
| ACETAMINOPHEN | — | Cyclooxygenase inhibitor | Phase 3 |
| PENTOXIFYLLINE | — | 3',5'-cyclic phosphodiesterase inhibitor | Phase 2 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed
EMA Status: Not yet disclosed
PMDA (Japan) Status: Not yet disclosed
NMPA (China) Status: Not yet disclosed
Development Status: Phase 1 completed as of October 13, 2017. No regulatory filings, approvals, or label expansions have been disclosed. Advancement to Phase 2 or regulatory pathway designation status is not yet disclosed.
Clinical evidence summary
Key questions answered
What is FMP012 with AS01B adjuvant system used for?
FMP012 with AS01B adjuvant system is a monoclonal antibody therapeutic candidate in development for the treatment of malaria. The specific therapeutic indication (treatment, prevention, or both) and target patient population have not yet been disclosed.
Is FMP012 approved by the FDA?
No. FMP012 with AS01B is in clinical development and has not received FDA approval. As of October 2017, the program had completed Phase 1 evaluation.
How does FMP012 work?
The mechanism of action of FMP012 has not yet been disclosed. The program combines FMP012 with the AS01B adjuvant system, suggesting an immunological approach to malaria, but specific target and functional mechanism remain undisclosed.
Who manufactures FMP012?
FMP012 with AS01B adjuvant system is being developed by United Therapeutics Europe Ltd. No manufacturing partnerships or commercial agreements have been disclosed.
What clinical trials support FMP012?
FMP012 with AS01B completed Phase 1 clinical evaluation under trial identifier NCT02174978. Detailed trial design, participant demographics, endpoints, and results have not yet been disclosed.
What is the current development phase of FMP012?
FMP012 with AS01B completed Phase 1 as of October 13, 2017. Advancement to Phase 2 or subsequent development stages has not been publicly disclosed.
What is the AS01B adjuvant system?
AS01B is a proprietary adjuvant system designed to enhance immune response. It is combined with FMP012 to potentially improve the therapeutic efficacy of the monoclonal antibody in malaria treatment or prevention.
What are the competitors to FMP012?
Approved antimalarials include artemether-lumefantrine (Coartem), artesunate-amodiaquine combinations, sulfadoxine-pyrimethamine, chloroquine, and primaquine. Emerging competitors include GSK's tafenoquine (Phase 3) and artemether-lumefantrine formulations by Avenue Therapeutics (Phase 3).
Is FMP012 a monoclonal antibody?
Yes. FMP012 is a monoclonal antibody (mAb) therapeutic candidate, representing a mechanistically distinct approach from the small-molecule antimalarials that currently dominate the malaria treatment landscape.
What is the indication for FMP012?
FMP012 with AS01B is in development for malaria. The specific indication (malaria treatment, prevention, or both) and target patient population have not yet been disclosed.
When was FMP012 first disclosed?
The first public disclosure date for FMP012 with AS01B has not yet been disclosed. The latest publicly available milestone is Phase 1 completion on October 13, 2017.
What is the target of FMP012?
The specific target of FMP012 has not yet been disclosed. The mechanism of action and molecular target remain undisclosed.
Does FMP012 have any partnerships?
No partnerships or licensing agreements have been disclosed for FMP012 with AS01B. The program is being developed by United Therapeutics Europe Ltd.
What are the expected next milestones for FMP012?
Expected next milestones for FMP012 have not yet been disclosed. Potential catalysts include Phase 2 initiation, mechanism of action disclosure, efficacy and safety data release, and regulatory pathway designation.
What is the peak sales projection for FMP012?
Peak sales projections for FMP012 have not yet been disclosed. Commercial potential depends on efficacy, safety, regulatory approval, and differentiation from existing antimalarials.
Is FMP012 in Phase 2 development?
No. As of the latest disclosed information (October 13, 2017), FMP012 with AS01B had completed Phase 1. Advancement to Phase 2 has not been publicly announced.
Entity relationship graph
FMP012 with AS01B adjuvant system → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Competitors
- artemether lumefantrine
- AL (Coartem)
- artemether-lumefantrine (ALN)
- Sulfadoxine-pyrimethamine
- Chloroquine
- Coartem™ (Artemether-lumefantrine combination)
- Artesunate-amodiaquine combination
- primaquine
- Amodiaquine plus Artesunate co-administration
- Tafenoquine
- abamectin and fenpyroximate
- Artemether-lumefantrine
- QUINIDINE GLUCONATE
- HYDROXYCHLOROQUINE SULFATE
- HYDROXYCHLOROQUINE
- DOXYCYCLINE
- DEXAMETHASONE
- CYTARABINE
- ACETAMINOPHEN
- PENTOXIFYLLINE
Analyst insights
Strategic Positioning: FMP012 with AS01B represents United Therapeutics Europe Ltd's exploratory entry into immunological approaches to malaria. The use of the AS01B adjuvant system suggests a strategy focused on enhancing adaptive immune responses, potentially for prophylactic or therapeutic benefit. This approach diverges from the sponsor's portfolio of established small-molecule antimalarials.
Development Status Concerns: Phase 1 completion in October 2017 with no subsequent publicly disclosed milestones raises questions regarding program advancement. The absence of Phase 2 initiation announcements or regulatory pathway guidance suggests either slow progression or deprioritization relative to other portfolio assets.
Competitive Implications: The monoclonal antibody modality offers potential mechanistic differentiation from small-molecule competitors. However, the program's early-stage status (Phase 1) and lack of disclosed efficacy or safety data limit competitive assessment. GSK's tafenoquine (Phase 3) and other advanced candidates represent more immediate competitive threats.
Future Catalysts: Key catalysts include Phase 2 initiation announcement, disclosure of mechanism of action and target, efficacy and safety data release, and regulatory pathway designation. The timeline to potential Phase 2 advancement and subsequent development milestones remains uncertain.
Unmet Needs Alignment: If FMP012 addresses drug-resistant malaria or provides superior prophylactic efficacy, commercial potential could be substantial. However, current disclosure limitations prevent assessment of unmet need alignment or differentiation rationale.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is FMP012?
- Monoclonal antibody therapeutic candidate for malaria in Phase 1 development by United Therapeutics Europe Ltd.
- What indication does FMP012 treat?
- Malaria; specific therapeutic use (treatment vs. prevention) not yet disclosed.
- What is the current development phase?
- Phase 1 completed as of October 13, 2017; Phase 2 status not yet disclosed.
- Who is developing FMP012?
- United Therapeutics Europe Ltd.
- Is FMP012 approved?
- No; program remains in clinical development with no regulatory approvals disclosed.
- What is the drug modality?
- Monoclonal antibody (mAb).
- What adjuvant is used with FMP012?
- AS01B proprietary adjuvant system to enhance immune response.
- How does FMP012 work?
- Mechanism of action not yet disclosed.
- What is the target of FMP012?
- Specific molecular target not yet disclosed.
- What is the clinical trial identifier?
- NCT02174978.
- Does FMP012 have partners?
- No partnerships or licensing agreements disclosed.
- What are the main competitors?
- Approved: artemether-lumefantrine, artesunate-amodiaquine, sulfadoxine-pyrimethamine. Phase 3: GSK tafenoquine.
- What is the route of administration?
- Route of administration not yet disclosed.
- When was Phase 1 completed?
- October 13, 2017.
- Are Phase 1 results published?
- Phase 1 results not yet reported publicly.
- What is the internal code?
- S-14-02.
- Is FMP012 for treatment or prevention?
- Specific therapeutic use (treatment vs. prevention) not yet disclosed.
- What is the peak sales projection?
- Peak sales projections not yet disclosed.
- What is the consensus analyst position?
- Consensus analyst position not yet disclosed.
- When is Phase 2 expected to start?
- Phase 2 initiation timeline not yet disclosed.
- Is FMP012 in EMA development?
- EMA development status not yet disclosed.
- What patient population does FMP012 target?
- Target patient population not yet disclosed; malaria-endemic or traveler populations likely.
Evidence & sources
- ClinicalTrials.gov NCT02174978 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0005136) (mondo)
- Orphanet — malaria (orphanet)
- NCT00001645 (clinicaltrials_gov)
- NCT00075049 (clinicaltrials_gov)
- NCT00111163 (clinicaltrials_gov)
- NCT00114010 (clinicaltrials_gov)
- NCT00115921 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.