AbbVie, Gubra Strike Deal to Develop Novel Weight Loss Treatment

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AbbVie and Gubra have agreed to terms on developing GUB014295, a weight loss treatment designed to help people manage weight by controlling their appetite. According to AbbVie, the long-acting amylin analog signals the brain to reduce hunger and slow digestion.¹

"At AbbVie, we are focused on transforming the future of patient care in areas where significant unmet need persists," said Robert A. Michael, CEO, AbbVie, in a press release. "Our partnership with Gubra marks our entry into the obesity field, offering a compelling opportunity based on the potential to address patient needs while also fostering long-term growth for our company."

Under the terms of the collaboration, AbbVie will handle development and global commercialization. Gubra will receive an upfront payment of $350 million, with the potential to receive an additional $1.875 billion pending development and sales milestones.¹

"We are excited to partner with AbbVie given its strong capabilities in both the development and commercialization of life-changing medicines," said Henrik Blou, CEO, Gubra, in the press release. "This collaboration between Gubra and AbbVie will accelerate the development of GUB014295 and build on the promising data shown in its Phase I single ascending dose trial. Our team has been extremely impressed with AbbVie and their commitment to bring this important partnership to life. We look forward to working together throughout the development of the GUB014295 program."

GUB014295 is currently in Phase I clinical trials.¹ In November 2024, Gubra announced promising results from the Phase I single ascending dose trial. According to the company, participants were randomly assigned in a 6:2 ratio to receive GUB014295 or a placebo. The primary endpoint was to assess the safety and tolerability of GUB014295, while secondary endpoints included its pharmacokinetic (PK) and pharmacodynamic effects.

PK analysis confirmed a once-weekly dosing schedule with a half-life of 11 days. Additional results showed that a higher dose of GUB014295 led to greater weight reduction, suggesting a dose-dependent effect on weight loss. Furthermore, effects were evaluated three days after initial dosing and continued for six weeks. In the groups receiving the three highest doses, mean body weight reduction reached an estimated 3%.

In terms of safety, GUB014295 was reported to be well tolerated, with the most common adverse events including nausea, vomiting, and reduced appetite.²

According to the Centers for Disease Control and Prevention (CDC), more than two out of every five adults in the United States are currently living with obesity. Between 2017 and 2020, the prevalence of obesity among adults over 20 years of age in the United States was 41.9%, up from 30.5% in 2000.

By age group, CDC data indicated that adults between 40 and 59 years had the highest obesity prevalence at 44.3%. Among adults aged 20 to 39 and those 60 or older, prevalence was 39.8% and 41.5%, respectively.³

"Obesity represents a significant global health concern with nearly 900 million adults affected, many of whom struggle to stay on current treatment options," said Roopal Thakkar, MD, EVP, research & development, chief scientific officer, AbbVie, in the press release. "Building on Gubra's experience in the discovery of novel peptide-based therapeutics, we look forward to advancing the development of the GUB014295 program."

References

1. AbbVie and Gubra Announce License Agreement to Develop an Amylin Analog for the Treatment of Obesity. AbbVie. March 3, 2025. Accessed March 3, 2025. https://news.abbvie.com/2025-03-03-AbbVie-and-Gubra-Announce-License-Agreement-to-Develop-an-Amylin-Analog-for-the-Treatment-of-Obesity

2. Gubra announces positive GUBamy Phase 1 SAD data (correction). Gubra. November 13, 2024. Accessed March 3, 2025. https://www.gubra.dk/mfn_news/gubra-announces-positive-gubamy-phase-1-sad-data-correction/

3. Adult Obesity Facts. CDC. Accessed March 3, 2025. https://www.cdc.gov/obesity/adult-obesity-facts/index.html#:~:text=Many%20U.S.%20adults%20have%20obesity,BMI%20of%2040.0%20or%20higher.