Revolutionary Reversible Anticoagulation

AYA1809002 is a first-in-class, reversible DNA aptamer-based anticoagulant targeting thrombin with high affinity and tunable control via a sequence-paired antidote. It is engineered to provide safe, effective, and rapidly reversible anticoagulation for use in hospital/acute care settings and high-risk patient populations.

AYA1809002 is a first-in-class, reversible DNA aptamer-based anticoagulant targeting thrombin with high affinity and tunable control via a sequence-paired antidote. It is engineered to provide safe, effective, and rapidly reversible anticoagulation for use in hospital/acute care settings and high-risk patient populations.

Precision Targeting

500× selectivity for thrombin over other proteases with 10 nM binding affinity ensures effective inhibition in both fluid phase and clot-bound contexts.

Rapid Reversal

Sequence-paired DNA antidote binds 1:1 to fully restore Factor II activity in under 30 minutes – without foreign proteins or immune responses.

Superior Safety

≥24 hour blood stability at 37°C with minimal off-target effects, no CYP interactions, and no food/vitamin-K restrictions.

Engineered Design

500× selectivity for thrombin over other proteases with 10 nM binding affinity ensures effective inhibition in both fluid phase and clot-bound contexts.

Direct Thrombin Inhibition

Clinical Indications

  • Non-valvular AF (stroke prophylaxis)
  • Treatment/prevention of DVT/PE
  • Acute coronary syndromes (adjunct)
  • HIT

Mechanism & PK Advantages

  • Competitive occupancy of thrombin’s catalytic cleft → blocks fibrinogen conversion & platelet activation
  • Linear, predictable PK: t½ ~10 h, steady state in 2–3 days, QD/BID dosing

Our Aptamer’s Clearance

  • Glomerular filtration only → rapid renal removal without active tubular secretion
  • Stable in renal impairment (minimal protein binding)
  • Versus FXa inhibitors: Xarelto ~33 % renal +CYP/P-gp (accumulates in CKD);  Apixaban ~25 % renal +   CYP3A4 interactions

Key Performance Metrics

  • 500× selectivity for thrombin; 10 nM affinity; 24 h+ blood stability
  • Dual activity: fluid-phase & clot-bound inhibition

Drug–Drug Interaction Profile

  • No CYP or P-gp liability → avoids warfarin-like interactions
  • No food/vitamin K restrictions

Inhibition of Clot-Bound Thrombin

AYA1809002 inhibits thrombin retained in fibrin clots. It binds to free and clot-bound thrombin, providing comprehensive anticoagulant activity.

Built-in Reversibility

Reversal Agent

Vitamin K / PCC
Protamine Sulfate
Idarucizumab

Modality

Cofactor ± concentrates
Polycation binds heparin
Humanized Fab for dabigatran

Key Limitations

Slow (6–24 h), thrombosis risk
Hypotension, anaphylaxis
$3 500+/vial, immunogenicity rebound risk

Comparison of Direct Thrombin Inhibition, Build in Reversibility, and Economic Burden

Comparison of Direct Thrombin Inhibition, Build in Reversibility, and Economic Burden

Direct Thrombin Inhibition Built-in Reversibility Economic Burden
Description Potent, predictable anticoagulation by blocking thrombin’s active site Rapid, on-demand neutralization (5 min) without triggering excess clotting ICH in 0.5–1.0 % of anticoagulated patients/yr, 50% 30-day mortality
Clinical Use Broad clinical utility (AF, VTE, ACS, HIT) Clinical flexibility for urgent procedures or bleeding Readmissions (15–20 % 30-day) → CMS penalties; litigation defense avg. $54 165
Outcome N/A Rapid Neutralization Major bleeds cost hospitals $25 000–$60 000 each; excess LOS +3.38 days (~$1 950/event)

Comparison of Anticoagulants: Mechanisms, Limitations, and the AYA189002 Solution

Comparison of Anticoagulants: Mechanisms, Limitations, and the AYA189002 Solution

Anticoagulant Mechanism      Key Limitations AYA1809002 Solution
Warfarin Inhibits vitamin K epoxide reductase → ↓ factors II, VII, IX, X
  • Narrow therapeutic index → requires frequent INR monitoring and dose titration
  • Extensive CYP2C9-mediated metabolism → multiple drug–drug & dietary interactions
  • Reversal via vitamin K/PCC slow (6–24 h) with risk of pro-coagulant overshoot
  • Direct, active-site thrombin blockade → predictable PK (t½~10 h)
  • No CYP or food/vitamin K interactions
  • Built-in DNA antidote delivers full reversal in 15–30 min
Factor Xa Inhibitors (e.g., Xarelto, Eliquis) Directly inhibit factor Xa → ↓ thrombin generation
  • Partial renal clearance (≈25–33 %) + CYP3A4/P-gp metabolism → accumulation in CKD & many DDIs
  • No intrinsic reversal; andexanet alfa expensive/supply-limited
  • Exclusively glomerular filtration → consistent clearance in renal impairment• No CYP/P-gp liability
  • On-demand molecular reversal without separate biologic
Unfractionated  Heparin Catalyzes  antithrombin III → inhibits thrombin & Xa
  • Requires continuous IV infusion & aPTT monitoring
  • Risk of HIT
  • Protamine sulfate reversal →  hypotension/anaphylaxis
  • Simple dosing (no aPTT monitoring)
  • No HIT risk
  • Sequence-paired DNA antidote vs. toxic protamine
Dabigatran (Pradaxa) Direct thrombin inhibitor
  • Relies on idarucizumab (humanized Fab) for reversal: high cost (~$3 500/vial), immunogenic risk, limited availability, potential rebound anticoagulation
  • Aptamer–antidote reversal built in: full clot restoration in <5 min
  • No foreign protein → no immunogenicity
  • Synthetic → lower cost and less batch to batch variation and higher stability

AYA1809002 Development Timeline (Projected)

Leadership & Scientific Team Bios

AYA1809002 Program

AyassBioScience, LLC Company Overview

Ayass Bioscience is an integrated molecular medicine company focused on redefining how complex diseases are diagnosed, monitored, and treated. Founded and led by physician-scientist Dr. Mohamad Ayass, the company unites high-complexity clinical diagnostics with cutting-edge therapeutic R&D under one translational platform.

At the center of its operations is Ayass Laboratory, a CLIA-certified facility supporting comprehensive genetic, genomic, and proteomic testing. Adjacent to the clinical lab is a robust research infrastructure, including flow cytometry and mass spectrometry cores, next-generation sequencing, and computational modeling.

In 2015, Ayass Bioscience established the Aptamer Center, which houses a multidisciplinary team dedicated to developing DNA aptamers as next-generation diagnostic and therapeutic tools. This program has yielded lead candidates across coagulation, immunology, and oncology — including AYA1809002, a reversible thrombin aptamer with first-in-class potential.

Complementing this is the company’s proprietary agentic AI platform (F420), designed to automate and interpret full transcriptome data for gene prioritization, pathway analysis, and therapeutic targeting. By integrating aptamer therapeutics with multi-omics-driven insights, Ayass Bioscience offers a scalable solution for personalized and adaptive molecular care.

With its unique clinical-research integration and AI-powered discovery engine, Ayass Bioscience is positioned to accelerate precision medicine from bench to bedside.

Dr. Mohamad Ayass, MD

President and CEO, Ayass Bioscience

Dr. Mohamad Ayass is a physician-scientist with board certifications in pulmonary and critical care medicine, and a lifelong commitment to merging clinical medicine with advanced molecular research. As the founder of Ayass Bioscience, Dr. Ayass pioneered the “Engineering the Medical Practice” paradigm—an integrative approach uniting clinical decision-making with genomics, transcriptomics, proteomics, and AI.

He established Ayass Bioscience’s aptamer therapeutic program out of a deep belief in their clinical potential, leveraging his medical insight to guide aptamer design and biomarker targeting. He leads the development of aptamers based on therapeutic need and biological relevance, with selections informed by his frontline clinical experience.

He currently leads the development of AYA1809002, a reversible DNA aptamer for anticoagulation. He also leads the conceptualization of aptamers targeting Ara h 2, a major peanut allergen, aligning molecular design with immunological desensitization strategies and extending the therapeutic potential of the platform into allergic disease.

Dr. Ayass is the visionary behind Ayass Bioscience’s agentic AI transcriptome platform, an intelligent system that transforms raw gene expression data into actionable therapeutic insights. This platform accelerates biomarker discovery, disease mapping, and therapeutic prioritization using AI-enhanced automation and robust biological context analysis.

Dr. Ayass also established the GEO (Genomics, Epigenetics, Omics) program and a leading flow cytometry laboratory for immune-profiling, driving translational innovation in thrombosis, oncology, and autoimmune diseases. He completed his medical education at Damascus University, followed by postgraduate training at the University of Michigan and University of Tennessee.

Dr. Lina Abi Mosleh, PhD

Vice President & Principal Scientist

Dr. Lina Abi Mosleh is Vice President and Principal Scientist at Ayass Bioscience, where she bridges fundamental biology with patient-focused translational research. She oversees the design and validation of cutting-edge molecular diagnostics and leads key initiatives in biomarker discovery, aptamer therapeutics, and systems biology.

Lina plays a central role in Ayass Bioscience’s aptamer discovery and validation program, leading initiatives that develop next-generation oligonucleotide therapeutics for coagulation, autoimmune, and oncology applications. She has also led the optimization of aptamer modifications to enhance nuclease resistance, reduce immunogenicity, and fine-tune clearance dynamics, ensuring robust performance across preclinical models and translational pipelines. Her work integrates biochemical screening with bioinformatics-guided candidate selection.

She also led the scientific coordination of an immunology-focused aptamer program targeting the Ara h 2 allergen, applying chemical design principles to minimize immunogenicity while enhancing precision binding. This work supports Ayass Bioscience’s broader strategy of using aptamers to selectively modulate pathological immune responses.

In parallel, she drives the company’s agentic AI platform for transcriptome analysis—an intelligent system that transforms raw gene expression data into actionable biological insights through automated prioritization, contextual enrichment, and real-time interpretation.

With a PhD in Molecular Genetics from UT Southwestern—mentored by Nobel Laureates Drs. Michael Brown and Joseph Goldstein—and prior academic appointments in cell biology, Lina brings a unique fusion of experimental depth and strategic leadership to the AI-driven future of precision medicine.

Kevin Zhu, MS

Bioinformatics Scientist

Kevin Zhu is a bioinformatics scientist at Ayass Bioscience, where he plays a pivotal role in the thrombin aptamer program by supporting sequence optimization, structural modeling, and binding affinity analysis. His work contributes to the molecular design of DNA aptamers with reversible anticoagulant properties and supports other aptamer initiatives targeting biomarkers in coagulation, autoimmune, and oncology research. He also contributed to the computational design of aptamers targeting the Ara h 2 allergen, modeling structural features and optimizing binding motifs to enable immune-safe allergen neutralization.

In parallel, Kevin is a principal developer of the company’s agentic AI platform for transcriptome analysis, a system that automates the transformation of raw RNA-seq data into prioritized gene signatures and pathway-level insights. He also contributes to the MoNet molecular network engine and develops internal tools that enhance genomic test interpretation and data workflow scalability.

Kevin holds an MS in Bioinformatics from UT Health and a BS in Computational and Applied Mathematics from Rice University.

Dr. Natalya Griko, PhD

Senior Scientist, Aptamer Development

Dr. Griko leads aptamer discovery efforts at Ayass Bioscience, where she specializes in the development and validation of high-affinity nucleic acid ligands targeting coagulation proteins, including thrombin and D-dimer. She has advanced multiple aptamer candidates through in vitro validation and contributes to multi-omics integration for biomarker identification.

Her work also spans transcriptomic analysis projects and the integration of gene expression data with molecular diagnostics. Dr. Griko earned her PhD in Molecular Biology from the Institute of Protein Research at the Russian Academy of Sciences and has held senior research roles in both academic and biotech environments.

Dr. Victor Pashkov, PhD

Research Scientist, Molecular Biology

Dr. Pashkov is a molecular biologist at Ayass Bioscience, contributing to aptamer development, high-complexity diagnostic assay design, and biomarker validation programs. He played a key role in developing and optimizing thrombin and D-dimer aptamer constructs and supports transcriptomic research workflows through expertise in assay development, PCR, and gene expression profiling.

He holds a PhD in Biochemistry from the Shemyakin–Ovchinnikov Institute of Bioorganic Chemistry (Russian Academy of Sciences) and has served as a research scientist at institutions including Cornell University Medical Center and UT Southwestern.

Dr. Jin Zhang, MD, MPH

Clinical Epidemiologist

Dr. Zhang supports clinical research design, statistical modeling, and biomarker validation at Ayass Bioscience. She provides deep expertise in study design, outcome prediction models, and population-level analytics for immune and coagulation-related conditions.

With formal training in medicine, pharmacology, and public health, she plays a key role in translating biological discoveries into rigorously validated clinical studies. Dr. Zhang earned her MD from China Three Gorges University, an MS in Pharmacology from the University of Mississippi Medical Center, and her MPH in Epidemiology from Jackson State University