Gubra: ABBV-295 data doesn’t seem that far from Eli Lilly's phase 1 data on Eloralintide

AbbVie today reported positive topline results from the multiple ascending dose (MAD) portion of the Phase 1 trial for ABBV-295, Gubra's out-licensed long-acting amylin analog.

The study demonstrated dose-dependent weight loss ranging from -7.75% to -9.79% at week 12 for weekly dosing cohorts, and -7.86% to -9.73% at week 13 for less frequent dosing regimens (every other week and monthly after week 5), compared to approximately -0.25% for placebo.

Importantly, ABBV-295 was well tolerated at all dose levels, with no serious adverse events reported and gastrointestinal side effects that were mostly mild and concentrated in the first six weeks of treatment. The data support continued development of ABBV-295 as a differentiated, non-incretin obesity treatment.

For Gubra, this is a significant de-risking event. ABBV-295 is the single most valuable asset in Gubra's pipeline, and the MAD readout represents the completion of a key milestone in the Phase 1 program. AbbVie has previously confirmed that ABBV-295 is its cornerstone obesity investment, and these results support continued advancement toward Phase 2, which AbbVie has guided to start towards the end of 2026. With up to USD 1.875bn in remaining milestones tied to development, approval, and commercialization.

To put the data in perspective against competing treatments:

Eli Lilly's Eloralintide in Phase 1 showed up to 11.3% weight loss at 12 weeks but as low as 2,6% weight loss in one of the cohorts and subsequently delivered 9.5% to 20.1% weight loss at 48 weeks in Phase 2, with Lilly now advancing into Phase 3. ABBV-295's MAD data at -9.79% over 12 weeks compares favorably at the Phase 1 level, particularly given the strong tolerability profile. Roche/Zealand Pharma's Petrelintide, meanwhile, achieved up to 10.7% weight loss at 42 weeks in Phase 2.

It should also always be noted that it’s challenging to compare directly between studies due to differences in patient populations. However, the Phase 1 population for Eloralintide (Eli Lilly) was patients with obesity, so normally a BMI 30+ population, versus ABBV-295's MAD population of mean BMI under 30. It’s also important to note the data on ABBV-295's long half-life, one of its main selling points. Dosing cohorts of every-other-week and monthly dosing showed competitive efficacy to weekly dosing, potentially enabling less-frequent dosing as a differentiator.

Looking at the side effects, there is no data but just a statement “ABBV-295 was well tolerated at all dose levels, with no serious adverse events reported and gastrointestinal side effects that were mostly mild and concentrated in the first six weeks of treatment”. The statement is similar to those made when Eli Lilly's Eloralintide data were published. Potential release of further data here will be interesting to follow, and may be another differentiator.

Looking at the profile of Phase 1 data on efficacy, indications supporting the long half-life as a selling point, and AbbVie's statement that the data support continued development, we see no reason to change the assumptions made in our investment case published today ahead of the data. We expect progression to Phase II clinical testing may support a greater market implied Probability of Success (PoS), as clinical progression raises the historical benchmark likelihoods for successful approval.

Tomorrow morning (10/03-2026) at 13:30 CET Gubra CFO Kristian Borbos and IR og Strategy Lead Emma Jappe Lange will give a presentation on the data (in English). Sign up here: https://www.inderes.dk/videos/gubra-presentation-of-phase-1-topline-results-on-abbv-295-long-acting-amylin-analog

Read the full investment-case here: https://www.inderes.dk/research/gubra-one-pager-enters-2026-with-three-differentiated-obesity-candidates-pivotal-data-readouts-expected-in-2026