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ExtenDRA: Real Human Data Study for Geroprotective Drug Repurposing

Submission Tracks

This study addresses all three submission categories:

  1. AI and ML-based aging biomarkers → ExtenDRA proteomic/metabolomic aging clock with uncertainty
  2. AI and ML using genomics, multi-omics, and drug discovery for aging → Multi-omics integration + perturbation-response drug ranking
  3. AI for clinical translation and trials in aging and aging-related diseases → Target trial emulation of geroprotective drugs in real EHR + outcomes data

Study Title

ExtenDRA: Deep Learning-Powered Multi-Omics Aging Clock and Drug Perturbation Framework for Identifying Geroprotective Agents from Human Population Cohorts


1. Study Overview

The Question

Among FDA-approved medications already taken by thousands of people, which ones slow biological aging — and can we measure this using real human multi-omics data?

The Design

A three-stage computational study using real human data only:

Stage What Data Output
Stage 1 Build a multi-omics biological age clock UK Biobank (53K proteomics + 275K metabolomics + clinical biomarkers) ExtenDRA-AgeClock: predicted biological age for every participant
Stage 2 Identify drugs that decelerate biological aging UK Biobank medication records + GP prescriptions + age acceleration Ranked list of 30+ drugs/classes associated with reduced age acceleration
Stage 3 Validate via target trial emulation UK Biobank longitudinal outcomes (mortality, multimorbidity, frailty) Causal effect estimates for top geroprotective candidates

Why This Works Without Fraud

  • UK Biobank is real data from ~500,000 participants with ethical approval
  • Medication records are from GP prescriptions (real exposures, not assigned)
  • Outcomes (death, disease incidence) are linked from NHS registries
  • We use target trial emulation (Hernán & Robins framework) to approximate causal inference from observational data — this is an established epidemiological method, not a claim of randomization
  • Every result carries uncertainty quantification and sensitivity analyses

2. Data Sources (All Real Human)

UK Biobank — Primary Cohort

Modality N participants Variables Status
Olink proteomics 53,014 2,923 proteins (Olink Explore 3072) Available
Nightingale NMR metabolomics 274,371 249 metabolites + ratios Available
Clinical biochemistry ~480,000 30+ blood/urine biomarkers Available
Genotyping ~488,000 800K SNPs + imputed ~90M variants Available
GP prescriptions ~230,000 Full medication history (BNF codes) Available
Hospital episode statistics ~500,000 ICD-10 diagnoses, procedures Available
Death registry ~500,000 Date + cause of death, 15+ years follow-up Available
Repeat assessment ~20,000 2nd visit proteomics/metabolomics (4-14yr gap) Available

Medication Classes to Test (>30 drugs, non-cancer focus)

Category Drugs/Classes N exposed (approx UKB) Aging Rationale
mTOR-adjacent Metformin ~30,000 TAME trial pending; reduces IGF-1/mTOR signaling
Statins Atorvastatin, Simvastatin, Rosuvastatin ~100,000 Anti-inflammatory; associated with lower biological age
ACE inhibitors Ramipril, Lisinopril, Enalapril ~60,000 RAS system modulates aging; worm/mouse lifespan extension
ARBs Losartan, Candesartan, Valsartan ~30,000 Same RAS pathway; potentially cleaner mechanism
SGLT2 inhibitors Empagliflozin, Dapagliflozin, Canagliflozin ~5,000+ Emerging geroprotective: caloric restriction mimetic
GLP-1 agonists Semaglutide, Liraglutide, Exenatide ~3,000+ Weight loss + anti-inflammatory + emerging longevity signal
Aspirin Low-dose aspirin ~50,000 Anti-inflammatory; ASPREE trial showed mixed aging results
Beta-blockers Bisoprolol, Atenolol, Propranolol ~40,000 Heart rate reduction; stress response modulation
Thiazide diuretics Bendroflumethiazide, Indapamide ~30,000 Blood pressure; some worm longevity data
PPIs Omeprazole, Lansoprazole ~40,000 Autophagy modulation; controversial aging effects
Allopurinol Allopurinol ~15,000 Xanthine oxidase inhibitor; reduces oxidative stress
Levothyroxine Levothyroxine ~40,000 Thyroid hormone; metabolic rate modulation
SSRIs Sertraline, Fluoxetine, Citalopram ~30,000 Serotonin signaling in C. elegans lifespan
Vitamin D Cholecalciferol ~20,000 Immune modulation; telomere association
Fibrates Fenofibrate, Bezafibrate ~5,000 PPARα agonists; metabolic aging

Total unique drugs/classes: 35+, all non-cancer primary indication.


3. Stage 1: ExtenDRA Multi-Omics Aging Clock

Architecture

Proteins (2,923 Olink) ─► SNN Encoder ─► z_prot (48-dim)
                                                 │
Metabolites (249 NMR) ──► SNN Encoder ─► z_met  │
                                                 ├─► CentralDogmaFusion ─► Predicted Age
Clinical (30 biomarkers) ► SNN Encoder ─► z_clin│
                                                 │
Genotype (PRS for aging) ► SNN Encoder ─► z_gen ┘

Training Target

Chronological age (continuous regression) with:

  • L1 loss (robust to outlier ages)
  • Trained on 80% of participants, validated on 10%, tested on 10%
  • Stratified by sex and ancestry

Output: Biological Age Gap

ΔAge = ExtenDRA_predicted_age − chronological_age
  • ΔAge > 0: biologically older than expected (accelerated aging)
  • ΔAge < 0: biologically younger than expected (decelerated aging)

Validation (Track 1: AI/ML-based aging biomarkers)

Validation Method Expected
Mortality prediction Cox PH: ΔAge → all-cause mortality HR per SD > 1.3
Disease prediction Logistic: ΔAge → incident diabetes, CVD, dementia AUC improvement over chronological age
Frailty association Correlation: ΔAge vs. frailty index ρ > 0.15
Heritability GREML on ΔAge h² ~ 0.10–0.20
Comparison to existing clocks vs. PhenoAge, GrimAge (methylation), ProtAge (Oh et al.) Competitive or better
Repeat-visit stability Test-retest on ~20K with 2nd visit ICC > 0.7

4. Stage 2: Drug Perturbation Scoring (Track 2: Multi-omics + Drug Discovery)

Design: Medication as Natural Perturbation

Instead of artificial perturbation data, we use real medication exposure as a natural experiment.

For each drug class D:

  1. Define exposed group: participants taking drug D at baseline
  2. Define unexposed group: matched participants NOT taking D (propensity-score matched on age, sex, BMI, smoking, comorbidities, other medications, deprivation, ethnicity)
  3. Compute:
ΔAge_exposed = mean biological age gap among exposed
ΔAge_unexposed = mean biological age gap among matched unexposed
Drug_aging_effect = ΔAge_exposed − ΔAge_unexposed

A negative Drug_aging_effect means the drug is associated with younger biological age.

ExtenDRA-Perturb Integration

Use the perturbation module to:

  1. Encode drug: SMILES → Morgan fingerprint / ChemBERTa embedding
  2. Encode baseline state: participant multi-omics → ExtenDRA latent state
  3. Predict perturbation response: FiLM conditioning → predicted proteomic/metabolomic shift
  4. Score: does the predicted shift oppose the aging direction?

This connects the heuristic drug-ranking to a learned perturbation model trained on real exposed/unexposed proteomic differences.

Confounding Control

Confounder Method
Indication bias (sicker people take drugs) Propensity score matching
Immortal time bias Landmark analysis (require 1yr exposure before clock measurement)
Polypharmacy Adjust for total medication count + specific co-medications
Reverse causation Sensitivity: exclude participants with prevalent disease at baseline
Genetic confounding Negative control outcomes + MR validation

Mendelian Randomization Validation

For drugs with known protein targets:

  1. Find pQTLs (protein quantitative trait loci) for the target protein in UKB
  2. Use cis-pQTL as genetic instrument
  3. MR outcome: ΔAge (biological age acceleration)
  4. If MR confirms same direction as observational → stronger causal evidence

Example: Statins target HMGCR → HMGCR pQTL → test causal effect on ΔAge.


5. Stage 3: Target Trial Emulation (Track 3: Clinical Translation)

Framework

For top 10 geroprotective candidates from Stage 2, run formal target trial emulations (Hernán & Robins 2016):

Trial Element Emulation
Eligibility Age 50–70, no prior cancer/CVD/dementia at index date
Treatment strategies Initiate drug D vs. do not initiate
Assignment Clone-censor-weight (inverse probability of censoring weights)
Follow-up start Date of eligibility + 1 year grace period
Outcomes All-cause mortality, incident multimorbidity (≥3 chronic diseases), frailty transition, composite aging endpoint
Follow-up Up to 15 years (UKB follow-up)
Analysis Pooled logistic regression with stabilized IPCW

Outcomes (Clinical Translation)

Outcome Definition Follow-up
All-cause mortality NHS death registry 15 years
Cardiovascular events ICD-10 I20-I25, I60-I69 15 years
Type 2 diabetes E11 new diagnosis 15 years
Dementia F00-F03, G30 new diagnosis 15 years
Multimorbidity transition 0-2 → 3+ chronic diseases 15 years
Frailty transition Fried criteria equivalent At repeat visit
Composite aging endpoint First of: death, dementia, frailty, or multimorbidity 15 years

Sensitivity Analyses

  1. Active comparator (e.g., metformin vs. sulfonylurea in diabetics)
  2. Dose-response (higher dose → more deceleration?)
  3. Duration-response (longer exposure → more benefit?)
  4. E-value for unmeasured confounding
  5. Negative control exposures (drugs with no plausible aging mechanism)
  6. Negative control outcomes (outcomes drug shouldn't affect)

6. ExtenDRA Platform Demonstration

What ExtenDRA Adds Over Existing Methods

Capability Standard approach ExtenDRA
Aging biomarker Single-omic (methylation OR proteomics) Multi-omic fusion following central dogma
Drug ranking Literature-based or single-omic association Perturbation-conditioned response prediction with uncertainty
Interpretation Black-box age prediction Per-protein/pathway attribution via Integrated Gradients
Uncertainty Point estimates only Ensemble + heteroscedastic variance → per-drug confidence intervals
Cross-validation Single cohort UKB discovery → longitudinal replication → MR validation

Platform Components Used

Stage 1 (Clock):
  extendra/models.py    → CentralDogmaFusion, OmicsEncoder, SNNStack
  extendra/losses.py    → L1 age regression + regularization
  extendra/causal.py    → Integrated Gradients for protein attribution

Stage 2 (Drug Perturbation):
  extendra/perturb/encoder.py      → Drug SMILES → embedding
  extendra/perturb/conditioning.py → FiLM: drug embedding modulates participant state
  extendra/perturb/model.py        → ExtenDRAPerturb: predict proteomic shift under drug
  extendra/perturb/ensemble.py     → Uncertainty quantification
  extendra/perturb/evaluate.py     → Pearson-Δ, DES@K, direction-match
  extendra/perturb/attribution.py  → Pathway-level drug mechanism

Stage 3 (Clinical Translation):
  extendra/pipeline.py  → End-to-end: data → clock → drug score → outcome validation
  extendra/trainer.py   → Training with Trackio monitoring

7. Expected Results and Deliverables

Primary Deliverables

  1. ExtenDRA-AgeClock — a multi-omics biological age predictor:

    • Trained on 53K UKB participants with proteomics + metabolomics
    • MAE < 4 years for chronological age
    • HR > 1.3 per SD of age acceleration for mortality
    • Publicly deposited model weights
  2. Geroprotective Drug Ranking — 35+ medications scored by age-deceleration effect:

    • Each drug: effect size + 95% CI + pathway attribution + MR p-value
    • Expected top hits: metformin, SGLT2i, GLP-1 agonists, ACE inhibitors
    • Novel candidates: drugs with unexpected age-deceleration signals
  3. Target Trial Results — top 10 drugs with formal causal estimates:

    • Hazard ratios for composite aging endpoint
    • Number needed to treat (NNT) for 5-year aging prevention
    • Dose-response and duration-response curves
  4. Open-source ExtenDRA platform — reusable for other cohorts:

Expected Positive Controls (Should Replicate)

Drug Expected direction Literature support
Metformin Age deceleration TAME trial rationale; diabetic survival paradox
Statins Age deceleration Anti-inflammatory; multiple observational studies
ACE inhibitors Age deceleration RAS modulation; worm/mouse lifespan
Rapamycin analogs Unknown in humans Strong pre-clinical; no UKB exposure data

Expected Negative Controls (Should Show No Effect)

Drug Expected Rationale
Antihistamines (cetirizine) No effect No aging mechanism
Antacids (calcium carbonate) No effect No aging mechanism
Topical treatments No effect No systemic exposure

8. Timeline

Month Milestone
1–2 UKB data access + QC + cohort assembly
2–3 Train ExtenDRA-AgeClock on proteomics + metabolomics
3–4 Validate clock against mortality, disease, frailty
4–5 Compute drug-specific age acceleration effects (35+ drugs)
5–6 Train ExtenDRA-Perturb on exposed/unexposed proteomic differences
6–8 Target trial emulations for top 10 candidates
8–9 MR validation for drugs with pQTL instruments
9–10 Sensitivity analyses + negative controls
10–11 Manuscript + poster preparation
11–12 Submission + code/model release

9. Why Funders Should Care

Market

  • Global longevity market: $44B in 2024, projected $93B by 2030 (CAGR 13%)
  • Drug repurposing: 10× cheaper than de novo discovery ($300M vs $2.6B)
  • UK Biobank is the world's largest population cohort with deep molecular phenotyping

Differentiation

  • Not another methylation clock — first multi-omic perturbation-response aging framework that directly scores drugs
  • Not just association — causal inference via target trial emulation + MR
  • Not black-box — interpretable per-protein/pathway attribution that pharma partners can act on
  • Immediate clinical translation: all drugs are already FDA-approved, already taken by thousands

IP/Moat

  • The trained ExtenDRA-AgeClock on UKB proteomics is a proprietary asset
  • Drug ranking + causal evidence = partnership leverage with pharma
  • Platform generalizes to other cohorts (All of Us, ARIC, Framingham)

Risk Mitigation

  • UKB data access is standard (approved in weeks, not months)
  • All drugs are real, all outcomes are real, all methods are published
  • Target trial emulation is accepted by FDA for regulatory evidence
  • Negative controls prevent false discovery claims
  • Every result carries uncertainty intervals

10. Ethical Considerations

  • UK Biobank data used under approved application (ethics: North West Multi-Centre Research Ethics Committee, 16/NW/0274)
  • No individual-level results returned to participants
  • Drug repurposing candidates are identified computationally — no clinical recommendations made without Phase III trials
  • All code and non-restricted model artifacts will be open-sourced
  • Equity: analysis includes ancestry-stratified results (UKB has ~5% non-European ancestry; limitations acknowledged)

11. Summary: Three-Track Alignment

Track ExtenDRA Contribution
AI/ML aging biomarkers Multi-omics biological age clock with uncertainty, validated against mortality/disease/frailty
AI/ML genomics + multi-omics + drug discovery Perturbation-response model trained on real medication-exposed proteomic shifts; MR-validated drug targets
AI for clinical translation Target trial emulation of 10+ drugs with HR estimates, NNT, dose-response — ready for Phase IV trial prioritization

References (Key Published Precedents)

  1. Oh et al. (2023) "Organ aging signatures in plasma proteomics track health and disease." Nature 624, 164–172. [53K UKB Olink; organ-specific aging clocks predict mortality]
  2. Argentieri et al. (2024) "Proteomic aging clock predicts mortality and identifies targets for healthy longevity." Nature Medicine. [UKB proteomic age → mortality HR 1.67/SD]
  3. Timmers et al. (2020) "Multivariate genomic scan implicates novel loci and haem metabolism in human ageing." Nature Communications 11, 3570. [pQTL + MR for aging/longevity]
  4. Lehallier et al. (2019) "Undulating changes in human plasma proteome profiles across the lifespan." Nature Medicine 25, 1843–1850. [2,925 proteins × 4,263 people; aging waves]
  5. Hernán & Robins (2016) "Using big data to emulate a target trial when a randomized trial is not available." American J Epidemiol 183(8):758–764.
  6. Sun et al. (2023) "Plasma proteomics identifies genetic associations with disease risk and drug targets." Nature Genetics 55, 1599–1608. [3,000+ pQTLs for MR drug target validation]
  7. Julkunen et al. (2023) "Atlas of plasma NMR biomarkers for health and disease in 118,461 individuals." Nature Communications 14, 604. [Nightingale metabolomics aging associations]
  8. TAME Trial Investigators (2024) "Targeting Aging with Metformin (TAME): rationale and design." [The first anti-aging RCT; metformin is the benchmark]