Ekdv-691
Pharmacodynamics (PD): A robust dose‑dependent reduction in circulating PRO‑C3 (a biomarker of type III collagen formation) and p‑SMAD2/3 levels in peripheral blood mononuclear cells (PBMCs) after 7 days of dosing, confirming target engagement.
| Study | Model | Dose / Regimen | Key Findings | |-------|-------|----------------|--------------| | In vitro fibroblast assay | Human primary lung fibroblasts (TGF‑β1‑stimulated) | 0.1–100 nM | Dose‑dependent ↓ α‑SMA, collagen‑I, fibronectin; EC₅₀ ≈ 15 nM | | DDR1‑dependent migration | Collagen‑I coated Boyden chamber with DDR1‑expressing CAFs | 10–500 nM | 80 % inhibition of migration at 100 nM | | Bleomycin‑induced lung fibrosis (C57BL/6 mice) | 10 mg/kg PO q.d. (14 d) starting day 7 post‑bleomycin | ↓ hydroxyproline content by 62 %; histology: ↓ Ashcroft score (3.1 → 1.1) | | Unilateral ureteral obstruction (UUO) renal fibrosis (rats) | 30 mg/kg PO q.d. (21 d) | ↓ renal collagen deposition by 48 % and preserved GFR | | Patient‑derived xenograft (PDX) of desmoplastic pancreatic cancer | 30 mg/kg PO q.d. + gemcitabine | Tumour volume reduction 55 % vs. gemcitabine alone; stromal α‑SMA density ↓ 70 % | | Safety pharmacology | hERG assay, CNS battery, cardiovascular telemetry in dogs | No QTc prolongation at 30× human Cmax; no CNS behavioural changes | | GLP toxicology | 4‑week repeat dose in rat & dog | NOAEL: 100 mg/kg (rat), 60 mg/kg (dog). No target‑organ toxicity, no mutagenicity (Ames, mouse micronucleus). | EKDV-691
Overall, the pre‑clinical package demonstrated that EKDV‑691 can simultaneously attenuate the canonical TGF‑β axis and DDR1‑mediated fibroblast‑matrix interactions, translating into meaningful antifibrotic efficacy in multiple organ systems. | Study | Model | Dose / Regimen
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| Issue | Current Mitigation |
|-------|--------------------|
| Cryogenic Packaging – Maintaining reliable interconnects at 4 K. | Use of silicon‑photonic waveguides and hermetic copper‑gold packages; extensive thermal‑stress testing. |
| Software Stack – Need for developers to think in hybrid terms. | EKVD‑691 ships with QR‑SDK, which extends Qiskit, Cirq, and PyTorch to expose a unified API (qr.run()). |
| Ecosystem Compatibility – Existing data‑center power budgets. | IPM allows dynamic mode switching; the chip can operate at room temperature (classical mode) when quantum acceleration isn’t needed. |
| Security Assurance – Verifying post‑quantum crypto implementations. | Independent third‑party audits (NIST, ENISA) scheduled for Q1 2026. |
