Hørsholm, Denmark and Ingelheim, Germany, 1 July, 2024 | Boehringer Ingelheim and Gubra today announced the launch of the Phase 1 study (NCT06352437) of BI 3034701, a long-acting triple agonist peptide with a potential to become a next-generation and first-in-class obesity treatment.
More than 1 billion people worldwide live with obesity, and numbers are continuing to rise. Estimations show that by 2035, 24% of the entire world population will be affected by this disease.[1] Obesity is a major risk factor for other cardiovascular, renal, and metabolic (CRM) diseases as well as for several types of cancer, which collectively are a leading cause of death worldwide. With the progression of BI 3034701, Boehringer Ingelheim further expands its pipeline of patient-centric solutions beyond weight loss for people living with obesity to achieve CRM health gain.
"Although early stage this is another step in our comprehensive strategy to improve the quality and length of lives of people living with interconnected cardiovascular, renal and metabolic diseases," says Søren Tullin, Senior Vice President and Global Head of Cardiometabolic Diseases Research, Boehringer Ingelheim. "BI 3034701 is the second out of several joint R&D programs with Gubra advancing into the clinic."
"We are very excited to see BI 3034701 now moving into phase 1. The global prevalence of obesity is increasing, and innovative treatments are indeed needed to tackle this complex, chronic disease. This triple agonist is a drug candidate targeting receptors known to induce weight loss and has a potential to become a next generation and first-in-class treatment for millions world-wide," says Henrik Blou, CEO at Gubra.
BI 3034701 was developed together with Gubra involving licensed IP from Gubra, with Boehringer solely responsible for further development and commercialization globally. The study is the second project in the partnership with Gubra to advance to the clinic, following BI 1820237, for which Phase 1 clinical results were announced in 2023.
The Phase 1, first-in-human, randomized, placebo-controlled trial, will assess safety, tolerability, and pharmacokinetics of the drug candidate (BI 3034701). The trial has 2 parts. Part A is open to healthy men between 18 and 55 years of age. Part B is open to people between 18 and 65 years of age with overweight or obesity who are otherwise healthy. Participants get different doses of BI 3034701 or placebo as an injection under the skin. In Part A, every participant gets a single dose. In Part B, every participant gets several doses of BI 3034701 or placebo.
In this study, BI 3034701 is given to humans for the first time. The trial with an estimated 124 participants is expected to be completed in the second half of 2025. Additional information about the Phase 1 trial is available via ClinicalTrials.gov (NCT06352437).
The initiation of the phase 1 trial will release a milestone payment to Gubra.
Contacts at Gubra
Media: Sofia Pitt Boserup, sbo@gubra.dk, +45 4188 9586
Investors: Kristian Borbos, kbo@gubra.dk, +45 3080 8035
About Gubra
Gubra, founded in 2008 in Denmark, listed on Nasdaq Copenhagen in 2023, is specialized in pre-clinical contract research services and peptide-based drug discovery within metabolic and fibrotic diseases. Gubra's activities are focused on the early stages of drug development and are organised in two business areas - CRO Services and Discovery & Partnerships (D&P). The two business areas are highly synergistic and create a unique entity capable of generating a steady cash flow from the CRO business while at the same time enjoying biotechnology upside in the form of potential development milestone payments and potential royalties from the D&P business. In 2023, Gubra had approx. 220 employees and revenue of DKK 205 million. See www.gubra.dk for more information.
About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com/uk (UK and Ireland) or www.boehringer-ingelheim.com (rest of world).
[1] World_Obesity_Atlas_2023_Report.pdf "The prevalence of obesity (BMI =30kg/m²) alone is anticipated to rise from 14% to 24% of the population over the same period, affecting nearly 2 billion adults, children and adolescents by 2035"
This information is information that Gubra is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-07-01 07:30 CEST.
