AbbVie amylin analog reaches phase 2 and gets a skin disease combination plan

The AbbVie amylin analog licensed from Gubra is picking up a second job. On 22 October, alongside phase 3 results for its skin disease antibody lutikizumab, AbbVie said it plans to test that antibody together with ABBV-295 in hidradenitis suppurativa, in a platform study expected to start later this year. The same molecule entered a phase 2 obesity trial in August, which moves it from phase 1 to phase 2 on our board. Both steps rest on company statements and a trial registry entry; no efficacy data exist for the combination.

The INTREPID trial readout behind the plan

The news that carried the plan was a readout for a different drug. Lutikizumab is an investigational antibody that blocks two inflammatory signals, interleukin 1 alpha and interleukin 1 beta, which AbbVie says are raised in the skin lesions of hidradenitis suppurativa, a painful chronic disease of nodules, abscesses and draining tunnels. The phase 3 INTREPID trial randomised about 1,400 adults and adolescents with moderate to severe disease to lutikizumab or placebo in equal numbers. Its main goal was HiSCR75, a response that requires at least a 75 percent drop in inflammatory lesions, measured at week 16. AbbVie reports that 31.4 percent of treated patients reached it, against 23.4 percent on placebo, a statistically significant gap.

The other results point in the same direction. A meaningful drop in skin pain at week 8 was reported by 26.2 percent of treated patients and 15.0 percent on placebo, and flares in the first 16 weeks affected 18.4 percent against 28.1 percent. Adverse events were about as common on drug as on placebo, and AbbVie said no new safety concerns were seen. The size of the main effect, an eight point gap, is modest, and fewer than a third of treated patients reached the primary threshold. That helps explain why AbbVie is already planning combinations. The release says the platform programme will test lutikizumab with ABBV-295 and possibly other mechanisms, including ABBV-701, an antibody against TL1A, with the stated aim of hitting several disease pathways at once.

What we know about ABBV 295

ABBV-295, also known by its Gubra code GUB014295, is a long acting analog of amylin, the pancreatic hormone that signals fullness after a meal. AbbVie took global rights from the Danish biotech in March 2025, as we reported when AbbVie entered obesity, and Gubra is eligible for up to 1.875 billion dollars in milestones plus tiered royalties. Detailed phase 1 results were presented at the EASD 2026 meeting in Milan on 30 September. In the multiple ascending dose part of the study, 60 participants were randomised to ABBV-295 or placebo for 12 or 13 weeks. Their mean age was 41.5 years, their mean BMI was 29.3, and 88 percent were men, so the early cohort says little about women or about people with higher body weight.

According to Gubra's summary of the presentation, weekly cohorts lost 7.8 to 9.8 percent of body weight by week 12, while placebo lost about 0.3 percent.

According to Gubra's summary of the presentation, weekly cohorts lost 7.8 to 9.8 percent of body weight by week 12, while placebo lost about 0.3 percent. An every other week cohort lost 9.7 percent and a monthly cohort 7.9 percent by week 13. The measured half life of roughly 11 to 12 days is what makes intervals longer than a week plausible. Nausea affected 33.3 percent on drug and 20.0 percent on placebo, and diarrhoea 20.0 percent against none, with most stomach events mild and concentrated in the first six weeks. There were no serious treatment emergent adverse events, and 4.4 percent of treated participants stopped for gastrointestinal reasons. These are small early cohorts, reported by the companies, and they set expectations rather than prove efficacy.

Why the molecule moves to phase 2 on our board

The stage change comes from the obesity programme, not the skin disease plan. ClinicalTrials.gov lists a phase 2 study of ABBV-295 in adults with obesity or overweight and weight related conditions, registered as NCT07752979, sponsored by AbbVie and recruiting. The record gives an actual start date of 4 August 2026, a planned enrolment of 360 people, and an estimated primary completion in March 2028. Gubra's EASD release confirms that the trial began in August. Our board still showed the molecule at phase 1, so this entry catches the board up with the registry. We log the move with an up signal because a randomised phase 2 trial is a real step forward for the AbbVie amylin analog, which until now had only phase 1 data.

The combination plan is a separate and much earlier idea. AbbVie has not said how many patients the hidradenitis suppurativa platform study will enrol, which doses it will test, or what role it expects amylin to play in an inflammatory skin disease. The release describes the rationale only in general terms, as targeting multiple pathways that may improve outcomes. It also says the study is expected to begin later this year, which leaves little time, and the release names no trial registry number for it. Until a protocol appears, the plan is an intention, not a trial. For readers comparing amylin programmes, our tracker lists every amylin molecule by stage, from early analogs to filed combinations.

How the AbbVie amylin analog fits the wider race

AbbVie came late to obesity, and ABBV-295 is the molecule that brought it into the field. Most rivals pair amylin with a GLP 1 signal, either as two molecules in one injection or as a single molecule that acts on both receptors. Novo's amycretin early trial result shows how far the dual approach has gone in small studies. The AbbVie amylin analog is so far being developed on its own, and the phase 2 trial will be the first real test of how much weight a pure amylin agonist can remove over a longer period. Putting it into an inflammatory disease programme is less common, and it gives AbbVie a second route for the molecule that does not depend only on winning a crowded obesity market.

There are reasons for caution on both fronts. Phase 1 weight loss over 12 weeks in mostly male, moderately overweight volunteers often shrinks or plateaus in larger and more diverse phase 2 populations, and the stomach side effects seen early may matter more at higher exposure. On the skin side, the lutikizumab result is positive but modest, and adding an amylin analog brings a new set of effects that the platform will need to separate from those of the antibody. AbbVie's INTREPID release stresses that both lutikizumab and its partners remain investigational and unapproved. This story reports pipeline research and is not medical advice.

Conclusion

The AbbVie amylin analog now has a phase 2 obesity trial running and a planned role in a hidradenitis suppurativa combination study, built around lutikizumab after a positive but modest INTREPID readout. The obesity trial is the step that counts: it moves the molecule to phase 2 on our board. The checkpoints are a registry entry for the skin disease platform study and phase 2 weight data, with primary completion estimated for March 2028.