Generated static export from Obsidian-friendly vault markdown
ClinPharm Vault

SEP-631

Overview

  • Priority class: MRGPRX2
  • Mechanistic bucket: MRGPRX2-pathway program
  • Sponsor: Septerna
  • Development focus: Program tracked in current raw-source layer
  • Indications represented in current raw sources: NR

Strategy readout

  • Headline: Pipeline-visible MRGPRX2 program without a disclosed CT.gov study stack in the current local cache.
  • Current strategic read: The current local layer shows SEP-631 as strategically interesting, but still early from an evidence-architecture perspective. Right now it reads more like a program signal from sponsor materials than a transparently disclosed clinical development strategy.
  • Highest visible phase in current registry: NR
  • Strategy confidence in current local layer: Low

Why this looks like the strategy

  • No CT.gov-linked urticaria records are currently captured in the local registry.
  • The visible strategy therefore comes mostly from sponsor and poster materials rather than a fully surfaced trial stack.

What to watch next

  • Whether a study record or more explicit protocol-level disclosure appears and allows stronger normalization.

Operational study design view

Trial Arms in registry Active dose regimens Total enrollment Per-arm sample size summary
Planned Phase 2b CSU study (sponsor slide deck) 5 4 NR 4 active SEP-631 oral QD dose levels plus placebo; enrollment not disclosed in current source.
  • Septerna corporate slide deck page 25 describes a planned global, randomized, double-blind, placebo-controlled Phase 2b CSU study with 4 SEP-631 oral QD dose levels plus placebo, adults 18 to 65 years who remain symptomatic on second-generation H1 antihistamine therapy, and change from baseline in UAS7 at week 12 as the primary endpoint.

Study Inventory

Completed / historical studies

  • None in current registry

Active / recruiting studies

  • None in current registry

Other registry entries

  • None in current registry

Program Results Summary

No CT.gov-linked trial in this program has a manuscript-backed result override yet.

Sponsor-sourced result evidence

Phase 1 proof-of-mechanism data available from AAAAI 2026 poster (sponsor-sourced).

SEP-631 Phase 1 SAD/MAD in healthy volunteers (NCT07069036) (Conference (sponsor poster)) - Complete inhibition of icatibant 10 µg/mL-induced skin wheals at doses as low as 10 mg QD after 9 days of treatment. - Complete inhibition of icatibant 100 µg/mL-induced skin wheals at 90 to 200 mg QD. - 120 participants dosed across SAD (n=48), MAD (n=64), and food-effect (n=8) parts. - PK profile supports once-daily oral dosing; no clinically meaningful food effect observed. - Safety: TEAE rate comparable with placebo across all dose cohorts; no severe or serious TEAEs. - Safety: SAD: most common TEAEs were headache (11.1% SEP-631 vs 8.3% placebo) and transaminase increases (5.6% vs 8.3%). - Safety: MAD: most common TEAEs were headache; one mild transaminase elevation with SEP-631 and one with placebo. - Source(s): raw/sponsors/mrgprx2/sep-631/aaaai-2026-poster-pdf.md

Evidence Coverage

  • CT.gov trials in registry: 0
  • Sponsor artifacts in registry: 3
  • Primary publications in registry: 0
  • Supporting publications in registry: 0
  • Publication status: no_pubmed_hits
  • Publication summary: No PubMed hits were returned for SEP-631 AND urticaria in this pass.

Primary publications

  • No primary publications currently linked in the registry

Supporting evidence

  • No supporting publications currently listed
  • Sponsor artifact: Pipeline page (Septerna)
  • raw/sponsors/mrgprx2/sep-631/pipeline-page.html
  • raw/sponsors/mrgprx2/sep-631/pipeline-page.md
  • Sponsor artifact: AAAAI 2026 poster PDF (Septerna)
  • raw/sponsors/mrgprx2/sep-631/aaaai-2026-poster-pdf.pdf
  • raw/sponsors/mrgprx2/sep-631/aaaai-2026-poster-pdf.txt
  • raw/sponsors/mrgprx2/sep-631/aaaai-2026-poster-pdf.md
  • Sponsor artifact: Corporate slide deck planned Phase 2b CSU study (Septerna)
  • raw/sponsors/mrgprx2/sep-631/septerna-corporate-slide-deck-phase-2b-csu-plan.pdf
  • raw/sponsors/mrgprx2/sep-631/septerna-corporate-slide-deck-phase-2b-csu-plan.txt
  • raw/sponsors/mrgprx2/sep-631/septerna-corporate-slide-deck-phase-2b-csu-plan.md

Interpretation

  • Verified facts: the current v2 registry tracks 0 CT.gov entries for this program and links them conservatively to sponsor and publication evidence where explicit identifiers are available.
  • Interpretation: this program is currently supported mainly by CT.gov and/or sponsor-source evidence, with weaker direct manuscript coverage in the local cache.
  • Open questions:
  • Several sponsor artifacts remain program-level because no explicit study identifier was captured in cached metadata.

Provenance

  • Primary source(s):
  • ../inventories/source_registry.json
  • ../inventories/source_registry.md
  • Supporting source(s):
  • ../inventories/ctgov_priority_trials.json
  • ../inventories/publication_priority_curation.json
  • ../inventories/sponsor_priority_sources.json
  • Last verified: 2026-04-08
  • Verification status: Partial

Change Log

  • 2026-04-08: Generated or refreshed this program page from the v2 source registry and local source caches.