NCT00308061
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported in available sources
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
FMP1/AS02A
Phase 1 · mab · Malaria
FMP1/AS02A (internal code WRAIR 1029) is a monoclonal antibody (mAb) candidate developed by United Therapeutics Europe Ltd for the treatment of malaria. The program completed Phase 1 clinical evaluation, with the latest milestone recorded on 31 July 2017. The candidate represents an alternative immunological approach t
Internal code WRAIR 1029
At a glance
- Sponsor
- United Therapeutics Europe Ltd
- Phase
- Phase 1
- Modality
- mab
- Indication
- Malaria
- Status
- completed
- Trials
- 1
Executive summary
FMP1/AS02A (internal code WRAIR 1029) is a monoclonal antibody (mAb) candidate developed by United Therapeutics Europe Ltd for the treatment of malaria. The program completed Phase 1 clinical evaluation, with the latest milestone recorded on 31 July 2017. The candidate represents an alternative immunological approach to malaria treatment, contrasting with the small-molecule antimalarial agents that dominate the current therapeutic landscape. The mechanism of action and specific target antigen have not been disclosed in available sources. Development status indicates the program has advanced through early-stage human safety and tolerability assessment. No subsequent milestones, regulatory filings, or approvals have been disclosed. The competitive environment includes established antimalarial combinations such as artemether-lumefantrine (Coartem), as well as investigational agents including tafenoquine (GlaxoSmithKline, Phase 3). The program's current development trajectory and commercial plans remain undisclosed.
Why this program matters
Malaria remains a significant global health burden, particularly in sub-Saharan Africa and Southeast Asia, with ongoing challenges related to drug resistance, treatment access, and tolerability. The development of novel immunological approaches, such as monoclonal antibodies targeting parasite antigens, represents a potentially valuable addition to the antimalarial arsenal. FMP1/AS02A's mAb modality offers a mechanistically distinct approach compared to conventional small-molecule antimalarials, which could provide benefits in terms of resistance profile, duration of action, or patient populations with contraindications to existing therapies. The completion of Phase 1 evaluation suggests the candidate demonstrated acceptable safety and tolerability in human subjects. However, the absence of disclosed Phase 2 or Phase 3 advancement, regulatory filings, or commercial partnerships as of the latest milestone suggests the program may face development challenges or strategic deprioritization. The competitive landscape includes multiple approved combination therapies and investigational agents in advanced development stages, indicating a crowded market with established treatment standards. The clinical and commercial significance of FMP1/AS02A remains contingent upon disclosure of efficacy data, regulatory pathway decisions, and strategic partnerships.
Drug intelligence
Drug Class: Monoclonal antibody (mAb)
Modality: Biologic (mAb)
Indication: Malaria
Mechanism of Action: Not yet disclosed
Target: Not yet disclosed
Sponsor: United Therapeutics Europe Ltd
Development Partner: Not yet disclosed
Route of Administration: Not yet disclosed
Related Therapies: The antimalarial landscape includes established small-molecule combination therapies (artemether-lumefantrine, artesunate-amodiaquine, sulfadoxine-pyrimethamine, chloroquine, primaquine) and investigational agents such as tafenoquine (GlaxoSmithKline, Phase 3).
Patent Status: Not yet disclosed
First Approval: 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 12017-07-31
Phase 1 completed
Latest disclosed milestone; Phase 1 clinical evaluation completed.
Competitive landscape
The antimalarial market is dominated by established small-molecule combination therapies, primarily artemether-lumefantrine (Coartem) and artesunate-amodiaquine combinations, which are approved and widely deployed globally. These agents represent the current standard of care for uncomplicated malaria in most endemic regions. Additional approved small-molecule options include sulfadoxine-pyrimethamine, chloroquine, and primaquine, though chloroquine resistance is widespread. In the investigational pipeline, tafenoquine (GlaxoSmithKline) is in Phase 3 development and represents a small-molecule approach with potential advantages in single-dose or short-course regimens. FMP1/AS02A's monoclonal antibody modality is mechanistically distinct from all identified competitors, potentially offering a novel approach to parasite neutralization or immune enhancement. However, the absence of disclosed efficacy data, Phase 2 advancement, or regulatory pathway clarity as of July 2017 suggests FMP1/AS02A faces significant competitive and development hurdles. The mAb approach may encounter challenges related to manufacturing scalability, cost, route of administration (likely parenteral), and clinical utility compared to oral small-molecule combinations that are logistically simpler and more cost-effective in resource-limited endemic settings.
| 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
Regulatory Pathway: Not yet disclosed
Approval History: No approvals disclosed. Program status as of 31 July 2017 indicates Phase 1 completion; no subsequent regulatory milestones, filings, or approvals have been disclosed in available sources.
Clinical evidence summary
Key questions answered
What is FMP1/AS02A used for?
FMP1/AS02A is a monoclonal antibody candidate in development for the treatment of malaria. Its specific mechanism of action and target antigen have not been disclosed.
What is the current development status of FMP1/AS02A?
Phase 1 clinical evaluation was completed as of 31 July 2017. No subsequent development milestones, Phase 2 initiation, or regulatory filings have been disclosed.
Who is developing FMP1/AS02A?
FMP1/AS02A is being developed by United Therapeutics Europe Ltd. The internal code is WRAIR 1029.
Is FMP1/AS02A approved by the FDA?
No FDA approval has been disclosed. The program remains in clinical development with Phase 1 completion as the latest disclosed milestone.
How does FMP1/AS02A work?
The specific mechanism of action and target antigen for FMP1/AS02A have not been disclosed in available sources.
What type of drug is FMP1/AS02A?
FMP1/AS02A is a monoclonal antibody (mAb), a biologic therapeutic modality distinct from the small-molecule antimalarials that currently dominate the market.
What clinical trial is associated with FMP1/AS02A?
NCT00308061 is the identified clinical trial associated with FMP1/AS02A. Detailed trial design, results, and outcomes have not been disclosed.
Does FMP1/AS02A have a development partner?
No development partner or licensing agreement has been disclosed for FMP1/AS02A.
What is the target antigen for FMP1/AS02A?
The specific target antigen has not been disclosed in available sources.
How is FMP1/AS02A administered?
The route of administration has not been disclosed. As a monoclonal antibody, parenteral (injection) administration is typical for this drug class.
What are the competitors to FMP1/AS02A?
Established competitors include artemether-lumefantrine (Coartem), artesunate-amodiaquine, and other small-molecule antimalarials. Investigational competitors include tafenoquine (GlaxoSmithKline, Phase 3).
When was FMP1/AS02A first disclosed?
The first disclosure date has not been recorded. The latest disclosed milestone is Phase 1 completion on 31 July 2017.
What is the mechanism of action of FMP1/AS02A?
The mechanism of action has not been disclosed in available sources.
Is FMP1/AS02A in clinical trials?
Phase 1 clinical evaluation was completed as of 31 July 2017. No subsequent trial initiation or results have been disclosed.
What is the projected peak sales for FMP1/AS02A?
Projected peak sales have not been disclosed.
What is the internal code for FMP1/AS02A?
The internal code is WRAIR 1029.
Entity relationship graph
FMP1/AS02A → 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: FMP1/AS02A represents United Therapeutics Europe Ltd's exploration of immunological approaches to malaria treatment. The completion of Phase 1 as of July 2017 indicates early-stage validation of safety and tolerability. However, the absence of disclosed Phase 2 initiation, efficacy signals, or regulatory advancement in subsequent years suggests the program may have encountered development challenges, strategic deprioritization, or commercial barriers.
Competitive Implications: The mAb modality offers mechanistic differentiation from small-molecule competitors but faces significant practical barriers in malaria treatment contexts, including manufacturing complexity, cost, parenteral administration requirements, and the established efficacy and accessibility of oral combination therapies. The program's advancement would require compelling efficacy advantages and a clear clinical niche (e.g., drug-resistant parasites, specific patient populations) to justify development investment.
Development Catalysts: Future advancement would likely require disclosure of Phase 1 safety data, Phase 2 efficacy signals, identification of a development partner or licensing agreement, and clarification of regulatory pathway and target patient population. The absence of such disclosures as of the latest available milestone suggests the program may be inactive or deprioritized.
Market Context: The global antimalarial market includes established standard-of-care therapies and investigational agents in advanced development. Novel approaches must demonstrate clear clinical advantages and feasibility in resource-limited endemic settings to achieve commercial viability.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is FMP1/AS02A?
- Monoclonal antibody candidate for malaria treatment by United Therapeutics Europe Ltd.
- What indication is FMP1/AS02A for?
- Malaria
- What is the current phase of FMP1/AS02A?
- Phase 1 completed as of 31 July 2017; no further advancement disclosed.
- Who is the sponsor of FMP1/AS02A?
- United Therapeutics Europe Ltd
- What is the drug modality?
- Monoclonal antibody (mAb)
- Is FMP1/AS02A approved?
- No approval has been disclosed.
- What is the mechanism of action?
- Not yet disclosed
- What is the target?
- Not yet disclosed
- Does FMP1/AS02A have a partner?
- No development partner has been disclosed.
- What is the internal code?
- WRAIR 1029
- What clinical trial is associated?
- NCT00308061
- What is the route of administration?
- Not yet disclosed; likely parenteral as a monoclonal antibody.
- What are main competitors?
- Artemether-lumefantrine, artesunate-amodiaquine, tafenoquine (Phase 3).
- When was Phase 1 completed?
- 31 July 2017
- What is the license type?
- Not yet disclosed
- Has Phase 2 been initiated?
- No Phase 2 initiation has been disclosed.
- What is the projected peak sales?
- Not yet disclosed
- Is there regulatory guidance?
- No regulatory pathway or guidance has been disclosed.
- What is the lead investigator?
- Not yet disclosed
- When was it first disclosed?
- First disclosure date not yet recorded.
- What is the consensus position?
- Consensus analyst position not yet disclosed.
- Is FMP1/AS02A active in development?
- Status unclear; no milestones disclosed since July 2017.
Evidence & sources
- ClinicalTrials.gov NCT00308061 (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.