OSE Immunotherapeutics has initiated a strategic realignment to enhance its focus on promising late-stage developments, particularly its ulcerative colitis candidate, lusvertikimab. This shift comes in the wake of Boehringer Ingelheim’s decision to withdraw from their partnership on the metabolic dysfunction-associated steatohepatitis (MASH) program after an exploratory Phase 2 study failed to meet its primary efficacy endpoint.
Disappointing Mid-Stage Results
The recent mid-stage study conducted by OSE did not yield results that would support the continuation of the MASH program. In a Monday announcement, OSE expressed that the findings were insufficient to justify further development in this area. The specifics of the trial data were not disclosed, leaving some uncertainty about the reasons behind the results.
Partnership History
OSE and Boehringer Ingelheim first established their partnership in April 2018, where an initial investment of €15 million was made, with further commitments and milestones potentially reaching up to €1.1 billion. The collaboration was strengthened in May 2024, with the MASH candidate, designated as BI 770371, being part of this enhanced agreement. However, the future of this partnership remains uncertain, as OSE currently lists BI 770371 as its sole asset under Boehringer’s collaboration on its official website.
Continued Oncology Development
Despite the discontinuation of the MASH program, OSE has clarified that the development of BI 770371 for cancer remains unaffected. The molecule operates under a distinct mechanism of action, and OSE is actively conducting multiple early-stage oncology studies that are advancing as planned. This indicates a continued commitment to exploring the therapeutic potential of BI 770371 beyond its initial MASH indications.
Strategic Refocusing
In light of the recent developments, OSE is implementing a strategic restructuring. The company has decided to deprioritize the investigational antibody OSE-230, which was being developed in collaboration with AbbVie for chronic and severe inflammation. This decision allows OSE to concentrate its efforts and resources on more advanced and promising assets within its portfolio.
Advancing Lusvertikimab
The primary focus will now shift to lusvertikimab, a CD127 blocker that has recently completed Phase 2 development for moderate to active ulcerative colitis. OSE is currently working on a subcutaneous formulation of this candidate, with expectations for it to be ready by the first half of 2027. Furthermore, a Phase 2b/3 trial for ulcerative colitis is anticipated to commence later that year.
Expanding Therapeutic Indications
In addition to ulcerative colitis, OSE plans to explore the development of lusvertikimab for chronic pouchitis and hidradenitis suppurativa. Initial Phase 2 data for these indications is expected by 2028, demonstrating OSE’s commitment to broadening the potential applications of this therapeutic candidate.
Challenges with OSE-230
The deprioritization of OSE-230 has not been without its challenges. Initially partnered with AbbVie in February 2025, this asset had a promising start, with an upfront payment of $48 million for exclusive rights. However, the agreement was amended in December 2025, shifting the responsibility for preclinical and Phase 1 development back to OSE. While AbbVie retains the option to oversee future clinical studies, OSE now bears the burden of early-stage development.
Conclusion
The recent changes at OSE Immunotherapeutics reflect a strategic pivot towards high-potential assets, particularly in the realm of ulcerative colitis. As the company reallocates its resources and focuses on advanced candidates like lusvertikimab, it aims to navigate the complexities of the biotech landscape more effectively. This transition underscores the dynamic nature of pharmaceutical development, where adaptability is crucial for success.
- OSE Immunotherapeutics is focusing on late-stage developments after Boehringer Ingelheim’s withdrawal from the MASH program.
- The exploratory Phase 2 study for the MASH candidate did not meet efficacy endpoints.
- OSE is prioritizing the development of its ulcerative colitis candidate, lusvertikimab.
- The company plans to expand lusvertikimab’s indications to chronic pouchitis and hidradenitis suppurativa.
- Challenges with the OSE-230 asset highlight the intricacies of biotech partnerships.
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