Gubra’s partner AbbVie presents detailed Phase 1 data for ABBV-295, a long-acting amylin analog, demonstrating favorable tolerability and pharmacokinetic profile at EASD 2026

• ABBV-295 demonstrated an approximately 11- to 12-day half-life and dose-proportional increases in plasma exposure, supporting evaluation of ABBV-295 at dosing intervals beyond weekly administration, including every-other-week and monthly regimens.
• ABBV-295 showed meaningful body weight reduction and favorable tolerability profile at all evaluated dose levels, with topline results announced earlier this year (AbbVie reports Positive Phase 1 Multiple Ascending Dose Results for ABBV-295, a Long-Acting Amylin Analog | Gubra).
• Results support advancement of ABBV-295, a non-incretin, amylin-based mechanism. A Phase 2 trial in adults with overweight and obesity was initiated in August 2026 (ClinicalTrials.gov ID: NCT07752979).

The detailed results being presented are from the 60 participants in Part 2B/2C of the MAD study, who were randomized to receive ABBV-295 (n = 45) or placebo (n = 15). Participants had a mean age of 41.5 years and a mean BMI of 29.3 kg/m², and 88% were male. ABBV-295 was dose-escalated to 4, 6, or 14 mg once weekly, 14 mg every other week, or 8 mg monthly, and administered for 12 or 13 weeks. ABBV-295 is an investigational therapy that represents a mechanistically distinct class from incretin-based therapies such as GLP-1 and GIP receptor agonists.

“The detailed data presented at EASD further highlight the differentiated profile of ABBV-295, including meaningful weight loss, favorable safety and tolerability, and a pharmacokinetic profile supporting the evaluation of dosing intervals beyond weekly administration. We are pleased to see the program advancing under AbbVie’s leadership,” said Markus Rohrwild, CEO of Gubra.

Key highlights from the short oral presentation include:

• Pharmacokinetic profile supports evaluation of dosing intervals beyond weekly administration: ABBV-295 demonstrated dose-proportional increases in plasma exposure across cohorts. Median Tmax ranged from 24.0 to 48.1 hours, and the mean half-life ranged from 10.7 to 12.3 days, a profile that supported the once-weekly, every-other-week, and monthly regimens evaluated in the study.
• Gastrointestinal (GI) safety findings: GI adverse events (AEs) were predominantly mild and occurred primarily during the first six weeks of treatment. Among participants who reported a GI AE, 92% reported mild events as the highest severity. Nausea was reported in 33.3% of participants receiving ABBV-295 compared with 20.0% receiving placebo. Diarrhea was reported in 20.0% of participants receiving ABBV-295 compared with 0.0% receiving placebo. No severe GI AEs were reported, and discontinuations due to GI AEs were infrequent overall (4.4% vs. 0.0%, all active vs. placebo).
• Tolerability: No serious treatment-emergent adverse events (TEAEs) were reported, and most events were mild. The most commonly reported adverse events (AEs) >20% were decreased appetite, fatigue, headache, nausea, and diarrhea.
• Meaningful weight loss observed across weekly, every-other-week, and monthly regimens: ABBV-295 demonstrated dose-dependent reductions in body weight over a 12- to 13-week treatment period. Least-squares (LS) mean body weight reductions ranged from -7.8% to -9.8% at Week 12 for the once-weekly dosing cohorts and were -9.7% for the every-other-week cohort and -7.9% for the monthly cohort at Week 13, compared with approximately -0.3% for placebo.

EASD Presentation Details:

Link to today’s press release from AbbVie: AbbVie Presents Detailed Phase 1 Data for ABBV-295, a Long-Acting Amylin Analog, Demonstrating Favorable Tolerability and Pharmacokinetic Profile at EASD 2026 - Sep 30, 2026.

About ABBV-295
ABBV-295 is an investigational, long-acting amylin analog being developed for chronic weight management and other potential indications. ABBV-295 was discovered by Gubra using Gubra’s streaMLine^TM platform. ABBV-295 has not been approved by any health regulatory authority worldwide. The safety and efficacy of ABBV-295 have not been established.

About the AbbVie and Gubra partnership
In March 2025, Gubra and AbbVie entered into a license agreement for ABBV-295. Under the terms of the agreement, AbbVie will lead development and commercialization activities of ABBV-295 globally. Gubra is eligible to receive up to USD 1.875 billion in potential development, commercial, and sales-based milestone payments, as well as tiered royalties on global net sales.

Contacts at Gubra
Media: Marianne Thomas (mho@gubra.dk, +45 2483 2663)
Investors: Kristian Borbos (kbo@gubra.dk, +45 3080 8035) and Adam Lange (adl@gubra.dk, +45 6646 1589)

About Gubra
Gubra, founded in 2008 in Denmark and listed on NASDAQ Copenhagen, is a disease-agnostic techbio company specialized in peptide-based drug discovery and preclinical contract research services. Gubra’s activities are focused on the early stages of drug development and are organized in three main business units – Biotech, CRO, and Ventures. The business areas create a unique entity capable of generating a steady cash flow from the CRO business while investing in high-impact biotech R&D projects with significant value inflection potential through partnerships. Gubra has around 300 employees and had revenue of DKK 2.6 billion (around $400 million) in 2025.
See www.gubra.dk for more information.

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