BI-3034701

Boehringer Ingelheim said on Thursday that it plans to put more resources behind its key late-stage pipeline assets as it continues to work towards a target of 25 new drug launches through 2030. Chairman Hubertus von Baumbach noted that recent data in metabolic dysfunction-associated steatohepatitis (MASH), coupled with pending read-outs in oncology, mental health and pulmonary fibrosis, “give us reason to accelerate our launch preparedness for these late-stage assets.”The company laid out its ambitious plans earlier this year, which at the time included the start of 10 mid- and late-stage studies over the next 12 to 18 months. “We are stepping up our investments in R&D beyond our plans announced in April,” von Baumbach remarked, noting that it has initiated five new Phase I, II or III studies in cardiometabolic diseases, mental health and oncology so far this year.These include moving the glucagon/GLP-1 receptor dual agonist survodutide (BI 456906) into late-stage development for MASH and kicking off a Phase I study of the long-acting triple agonist peptide BI 3034701 for obesity. “As our pipelines continue to expand, both in depth and breadth, we need to apply a rigorous focus where we allocate our resources,” said Frank Hübler, Boehringer Ingelheim’s board member responsible for finance.Boehringer Ingelheim also reported Thursday that sales of human prescription medicines in the first half of the year grew 9.3% on a currency-adjusted basis to €10.3 billion ($11.3 billion), mainly driven by Jardiance and Ofev. The company’s overall revenue in the six-month period increased 7.4% to €12.9 billion ($14.1 billion).

Boehringer Ingelheim and partner Gubra on Monday launched a Phase I study of experimental obesity treatment BI 3034701, the second weight-loss candidate from the partners to enter the clinic. In the announcement, BI 3034701 is described as a “long-acting triple agonist peptide” with first-in-class potential. The German drugmaker did not respond to an inquiry regarding whether the candidate acts on the same three receptors as Eli Lilly’s weight-loss therapy retatrutide, commonly referred to as a “triple G” agonist because it targets GLP-1, GIP, and glucagon. Last year, retatrutide set the triple agonism standard by demonstrating an average weight loss of about 24% in a Phase II trial.Weight loss pipelineThe Phase I study of BI 3034701 is expected to enrol 124 participants and will be divided into two parts. The first half will recruit healthy men between the ages of 18 and 55 to establish the candidate’s safety, and the second portion will administer several subcutaneous doses of the experimental treatment to individuals between 18 and 65 years old with overweight or obesity who are otherwise healthy.The trial is expected to wrap up in the second half of 2025.The study launch triggered an undisclosed milestone payment to Gubra, who has now helped bring two obesity candidates to the clinic with Boehringer. Last year, the partners kicked off a Phase I study of BI 1820237, a long-acting NPY2 agonist.Boehringer’s most advanced weight loss hopeful is survodutide, a glucagon/GLP-1 receptor dual agonist it’s co-developing with Zealand. While Phase II data released last year showed that the candidate achieved about 19% weight loss in patients at 46 weeks, nearly a quarter of participants who received the investigational treatment dropped out due to gastrointestinal adverse events. For more analysis, see ADA23: Tolerability clouds Boehringer, Zealand Pharma's obesity ambitions for survodutide.Despite the tolerability concerns, the pair moved survodutide into a Phase III trial last August. The candidate is also in Phase III testing for metabolic dysfunction-associated steatohepatitis (MASH).