Attovia Therapeutics, Inc. filed a Form 8-K on November 9, 2026, disclosing positive topline 12-week results from its Phase 1b study of ATTO-1310 in patients with chronic pruritus and high-itch atopic dermatitis, alongside a report of its third-quarter 2026 financial results.

Key Highlights

  • Single dose, 12-week IL-31 suppression: A single subcutaneous dose of ATTO-1310 produced approximately 95% suppression of circulating IL-31 through Week 12, with drug concentrations remaining above the IC90 throughout the period, according to the filing.
  • Chronic pruritus itch response at Week 12: 82% of ATTO-1310-treated patients with chronic pruritus achieved a reduction of 4 or more points on the Peak Pruritus Numerical Rating Scale (PP-NRS4) versus 22% with placebo (p < 0.01) at Week 12.
  • Itch-free or nearly itch-free response in CP: 47% of ATTO-1310-treated chronic pruritus patients achieved a PP-NRS score below 2 at Week 12 versus 0% with placebo (p < 0.05).
  • Low immunogenicity observed: Anti-drug antibodies were detected in 7.8% of healthy volunteers and patients, with no reported impact on pharmacokinetics, target engagement, tolerability, or clinical activity.
  • Phase 2 trials planned for 2027: The company disclosed plans to initiate the ATTUNE-CPUO trial (approximately 300 patients, 78 sites) and the ATTUNE-AD trial (approximately 255 patients, approximately 60 sites), both on track to begin in the first half of 2027.
  • Q3 2026 financial results reported: The company issued a press release on November 9, 2026 reporting financial results for the third quarter ended September 30, 2026, furnished as Exhibit 99.1.

ATTO-1310 Phase 1b Data: Tolerability, Pharmacology, and Clinical Outcomes

According to the filing, Attovia Therapeutics (NASDAQ:ATTO) reported that ATTO-1310, described as a "next-generation anti-IL-31 ATTOBODY-based precision itch therapy," was generally well tolerated in both healthy volunteers and patients. In the healthy volunteer portion of the study, one treatment-emergent adverse event (TEAE) led to treatment discontinuation due to a Grade 1 fever. No TEAEs led to discontinuations among chronic pruritus or atopic dermatitis patients. The filing noted one serious TEAE involving worsening of a pre-existing hiatal hernia, which was deemed unrelated to study treatment.

The filing disclosed that in patients with chronic pruritus, a clinically meaningful PP-NRS4 response was observed as early as Week 2, with 47% of ATTO-1310-treated patients achieving that threshold versus 0% with placebo (p < 0.05). That response rate rose to 82% versus 22% with placebo (p < 0.01) at Week 12. In patients with high-itch atopic dermatitis, 39% of ATTO-1310-treated patients achieved PP-NRS4 at Week 2 versus 25% with placebo, increasing to 44% at Week 4 and sustaining through Week 12. The filing also reported that in the pooled placebo group (n=8) for the AD cohort, the PP-NRS4 response rate rose from 25% at Week 4 to 75% at Week 12. In addition, the company reported improvements in skin disease severity assessed across Eczema Area and Severity Index (EASI) and validated Investigator Global Assessment (vIGA) endpoints in AD patients.

Regarding pharmacology, the filing stated that drug concentrations remained above the IC90 through Week 12 following a single subcutaneous dose, which the company indicated supports the potential for quarterly maintenance dosing. The filing contains forward-looking statements, which the company identified as subject to risks and uncertainties, including those related to clinical trial results, regulatory approvals, and broader macroeconomic conditions, as described in the company's cautionary language.

What Was Disclosed

Attovia Therapeutics filed an 8-K on November 9, 2026 reporting positive Phase 1b topline 12-week data for ATTO-1310 in chronic pruritus and high-itch atopic dermatitis patients, along with plans for two Phase 2 trials and a third-quarter 2026 financial results press release.