ALLN-346 — Engineered urate oxidase
Allena Pharmaceuticals, Inc. · Hyperuricemia in patients with gout · Oral engineered urate oxidase
50 submissions · 527 documents · Cleared 13 Feb 2020 · with Pre-IND correspondence
About this submission
Phase 1 IND for an engineered uricase targeting hyperuricemia and gout in chronic kidney disease patients. A useful reference for first-in-human dosing strategy and CMC for an engineered protein therapeutic.
Complete INDs are almost never made public — so if you're drafting one or preparing for your first FDA meetings, this is a rare chance to read a real one end to end. It's a Phase 1 IND for an engineered, gut-restricted uricase aimed at the hardest case in gout: patients with advanced chronic kidney disease, in whom standard urate-lowering drugs are limited or unsafe. The enzyme works in the gut and is essentially not absorbed — so the development questions are unusual, and the FDA's answers are instructive. A clean, briskly run early program you can treat as a worked example: first-in-human dosing of a non-absorbed protein, the supporting CMC, and the nonclinical package the FDA will (and won't) accept for a locally-acting biologic.
“At this time, we do not agree. … due to the biological action of ALLN-346 … it may confer some indirect effects on a mother and/or fetus. Therefore, we recommend … an embryo-fetal development (EFD) study in rats (or rabbits) be completed prior to the initiation of any phase 3 clinical trials.”
What the FDA dialogue reveals
- A textbook expedited program. The IND cleared its FDA safety review (a February 2020 Study May Proceed letter), and the FDA granted Fast Track designation 55 days after the request — comfortably inside the 60-day statutory clock.
- Where the FDA gives, and where it holds. In a 2021 Type C interaction the FDA agreed the drug's lack of systemic absorption justified a lighter nonclinical package — a single-species 6-month chronic-toxicology study, with safety-pharmacology and ADME studies waived — but required an embryo-fetal development study before any Phase 3. A concrete precedent for de-risking a gut-restricted protein.
- All written responses, no live meetings. Every FDA interaction here was handled in writing — a model of how lean, modern early-stage dialogue actually happens.
Best studied for
First-in-human dosing strategy for a non-absorbed enzyme · CMC for an engineered protein therapeutic · benchmarking nonclinical waivers and expedited-program requests for locally-acting biologics.
Related reading
Reading Between the Lines: What the FDA Says vs. What It MeansA field guide to FDA correspondence, drawn from complete INDs in the archive.Browse the complete eCTD package — 527 documents across Modules 1–5 — cover letter, administrative forms, summaries, CMC, nonclinical, and clinical study reports. Free account required.
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