Pioneering American research and development at the intersection of God's word and modern science. Prayer-driven. Providence-led.
Acts 38–47 LLC is a U.S.-based research and development company built on the conviction that the greatest breakthroughs emerge when God acts, when biblical principles guide scientific inquiry.
We operate at the frontier of American innovation, bringing rigorous methodology and moral clarity to the questions that matter most. Our work is not theoretical — it is applied, purposeful, and grounded in an unshakable foundation given to us by Jesus Christ [Yeshua] our Lord and Savior.
"For I know the plans I have for you, declares the Lord, plans to prosper you and not to harm you, plans to give you hope and a future."
Jeremiah 29:11Our research spans disciplines united by a single thesis: that principled inquiry, anchored in God's truth, produces solutions of lasting value for America and the world. In the spirit of Christ & the Great Commission.
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A comprehensive, individualized therapeutic pathway leveraging breakthrough RNA silencing technology and the FDA's new Plausible Mechanism Framework. Full indication details available to authorized recipients only.
Restricted to authorized partners, collaborators, and credentialed researchers. Enter your access code or submit your institutional email to unlock all 15 sections.
This document outlines a comprehensive pathway for developing an N-of-1 individualized therapeutic solution for a pediatric patient with Juvenile Idiopathic Arthritis (JIA) that may progress to Rheumatoid Arthritis (RA). The strategy leverages breakthrough RNA silencing technology — antisense oligonucleotides (ASOs) and siRNA — combined with the newly released FDA Plausible Mechanism Framework (February 2026).
The pathway integrates whole genome sequencing and pharmacogenomic profiling through CLIA-certified laboratories; target identification using established JIA/RA GWAS data; custom ASO design through n-Lorem Foundation, Secarna Pharmaceuticals, and Ionis Pharmaceuticals; and R&D funding partnerships with Regeneron and Alnylam Pharmaceuticals.
While JIA/RA is a complex polygenic autoimmune disease, the FDA's Plausible Mechanism Framework and the emerging JIA genetic literature — identifying specific causal variants (ERAP2, HLA alleles, NLRP3, IL-1β, PTPN22) — open a pathway for targeted RNA-based intervention, particularly for patients with identifiable high-impact genetic drivers.
Full framework requires authorization. Enter your access code or submit your institutional email to unlock.
Juvenile Idiopathic Arthritis (JIA) is the most common chronic arthropathy of childhood, with an estimated prevalence of 45 cases per 100,000 children in North America. Under ILAR criteria, JIA comprises seven distinct subtypes:
| Subtype | Clinical Features | Key Genetic Associations |
|---|---|---|
| Systemic JIA (sJIA) | Arthritis + quotidian fever + rash; risk of MAS | IL-1 pathway, NLRP3 inflammasome |
| Oligoarticular JIA | ≤4 joints; most common; early onset 2–4 yrs; ANA+ | HLA-A2, DRB1*08, DPB1*0201 |
| RF-Negative Polyarticular | ≥5 joints; RF negative; variable age onset | Similar to oligoarticular; age-specific HLA effects |
| RF-Positive Polyarticular | ≥5 joints; RF+; closest to adult RA | HLA-DRB1 shared epitope; PTPN22 |
| Enthesitis-Related (ERA) | Arthritis + enthesitis; axial involvement | HLA-B27 (strongest association) |
| Psoriatic JIA | Arthritis + psoriasis or psoriatic features | HLA-Cw*0602; IL23R variants |
| Undifferentiated | Does not fit other categories | Variable |
GWAS and candidate gene studies have identified multiple loci. Recent integrative analyses (2023–2024) identified 52 genes with putative causal roles, 44 (85%) within the HLA locus.
Fan et al. (JAMA Network Open, 2024): JIA and adult RA share substantial genetic overlap, supporting drug repurposing strategies. RF-positive polyarticular JIA may be considered the pediatric counterpart of adult RA, validating the relevance of adult RA pharmaceutical pipelines for pediatric JIA applications.
An N-of-1 pharmacogenomic (PGx) therapeutic represents a paradigm shift from traditional mass-market drug development to a bespoke model where the drug is custom-designed for a single patient's genetic profile. This approach is particularly valuable when the patient carries a rare or unique genetic variant, standard treatments have failed, or a clear molecular target can be identified and validated.
Use PGx testing and N-of-1 crossover trials to identify the optimal existing therapy. Studies show 47% cost reduction vs. open access to high-end biologics.
Bespoke RNA-silencing therapeutic targeting the patient's specific causal genetic variant. Higher cost; potentially curative for monogenic forms.
RNA silencing — awarded the 2006 Nobel Prize — encompasses two primary modalities:
Non-profit providing free ASO development and lifetime supply for qualifying nano-rare patients (<30 patients globally). Florida partner: Dr. Majed Dasouki at AdventHealth for Children.
Proprietary OligoCreator® platform; active NLRP3 ASO program targeting inflammatory and autoinflammatory diseases with published pre-clinical arthritis data. Prime co-development target for sJIA.
World's leading ASO company; AKCEA pipeline includes autoimmune-adjacent indications. Potential CDMO or co-development partner.
Active siRNA partnership with Alnylam; Truveta DNA-linked database; cemdisiran demonstrates autoimmune siRNA capability. Engagement: scientific partnership + pediatric autoimmune data sharing.
RNAi leader with $3B revenue; 2-2-5 pipeline expansion goal. Active immunology partnerships with City Therapeutics and ADARx.
The FDA Plausible Mechanism Framework (February 2026) enables IND submission based on a scientifically plausible biological rationale rather than traditional Phase I/II efficacy data — critical for N-of-1 programs where no trial cohort exists.
| Test | Provider | Purpose | Est. Cost |
|---|---|---|---|
| Clinical WGS | Broad Clinical Labs | Whole genome; CLIA-certified; variant detection | ~$1,500–$3,000 |
| HLA High-Res Typing | BCL / specialized lab | DRB1, DPB1, B27 allele determination | ~$500–$1,000 |
| PGx Panel | BCL / Mayo Clinic Labs | Biologic metabolism; TPMT, DPYD | ~$500–$1,500 |
| RNA-seq (optional) | BCL / research partner | Expression confirmation of target pathways | ~$500–$2,000 |
| BGE | Broad / BCL | Cost-optimized WGS+WES hybrid; high-sensitivity for rare variants | ~$1,000–$2,000 |
Variant analysis cross-references: gnomAD, GWAS Catalog (GCST90010715), ClinVar, PharmGKB, CPIC, OMERACT.
| Model | Structure | Best For | Target Partners |
|---|---|---|---|
| A — SRA | Pharma funds 501(c)(3); retains publication rights; pharma gets IP option | Early-stage target discovery; building data assets | Regeneron (Truveta), Alnylam |
| B — Data Sharing | 501(c)(3) shares de-identified data; pharma pays access fees | Multiple pharma relationships | All major players |
| C — Co-Development | Joint ASO candidate; shared costs, IP, milestones | Validated target with commercial potential | Secarna (NLRP3), Ionis |
If the patient qualifies for the n-Lorem Foundation nano-rare pathway, total program cost is reduced to genomic profiling only: $3,000–$8,000. The budget below applies to the full commercial ASO development path.
| Category | Low Estimate | High Estimate |
|---|---|---|
| Genomic Profiling (WGS, HLA, PGx, RNA-seq) | $3,000 | $8,000 |
| Bioinformatics & Target Identification | $15,000 | $50,000 |
| IRB & Regulatory Consulting | $25,000 | $75,000 |
| ASO Design & Synthesis | $200,000 | $500,000 |
| Preclinical Toxicology | $300,000 | $800,000 |
| GMP Manufacturing (Initial Batch) | $150,000 | $400,000 |
| IND Preparation & FDA Fees | $50,000 | $150,000 |
| Clinical Monitoring (Year 1) | $100,000 | $250,000 |
| Legal & Administrative | $25,000 | $75,000 |
| Contingency (15%) | $130,000 | $350,000 |
| Total | $1,000,000 | $2,660,000 |
| Risk | Impact | Mitigation |
|---|---|---|
| No druggable target identified | Program cannot proceed to ASO development | Comprehensive genomic profiling; Approach A (drug optimization) as fallback |
| Joint delivery challenge | ASO cannot reach synovium effectively | Target systemic pathways (liver-expressed cytokines); monitor Secarna joint delivery research |
| n-Lorem non-qualification | Must fund development independently ($1–3M) | Seek pharma partnership; pursue alternative CDMO path |
| FDA regulatory uncertainty | Plausible Mechanism Framework is draft guidance | Early FDA engagement; align with existing ASO guidance documents |
| Disease heterogeneity | JIA subtypes may have different genetic drivers | Precise subtype classification; subtype-specific target selection |
| Funding shortfall | Delays or program termination | Phased approach; milestone-based fundraising; pharma partnership |
Complete list of validated JIA genetic associations in GWAS Catalog accession GCST90010715 and referenced publications.
n-Lorem typical timeline: 12–18 months from application to first dose. Commercial ASO development: 18–36 months from target identification to IND.
Version 1.0 · March 2026 — Initial comprehensive framework. Prepared by Acts 38–47 LLC.