Eli Lilly has discontinued three clinical-stage drug candidates as it awaits an FDA approval decision for its oral GLP-1 candidate orforglipron. The programs include a gene therapy acquired through the company’s $1 billion acquisition of Prevail Therapeutics, an anti-CD19 antibody tested in autoimmune diseases, and an investigational radioligand therapy for prostate cancer.
The gene therapy, LY3884963, previously known as PR006, was being developed for frontotemporal dementia linked to changes in the progranulin (GRN) gene, a condition referred to as FTD-GRN. The neurodegenerative disease is primarily inherited and can lead to changes in behavior and executive functioning.
LY3884963 originated from Lilly’s acquisition of Prevail Therapeutics in 2020 and entered a phase 1/2 clinical trial the same year. At the time of discontinuation, the therapy was in the later stage of the study. The trial consisted of five treatment cohorts that varied by dose, dosing approach, and stage of disease.
“Lilly discontinued GRN gene therapy in frontotemporal dementia due to a lack of compelling efficacy in the studied patient population. The decision was not due to any safety concern,” a Lilly spokesperson said. According to ClinicalTrials.gov, the study was scheduled to produce a primary readout in 2031, with the main objective of evaluating safety and the therapy’s effect on GRN levels. Patients already enrolled in the trial will continue in a safety follow-up period. The spokesperson added that Lilly plans to share data from the program at a future scientific meeting.
The company continues to develop other gene therapies, including a mid-stage GBA1 gene therapy that Prevail had identified as its lead program, which is being studied in Parkinson’s disease and Gaucher disease type 1. Last week, Lilly also announced a deal potentially worth more than $1 billion to participate in the development of a genetic medicine for hearing loss with Seamless Therapeutics.
Lilly has also discontinued LY3541860, an anti-CD19 antibody that had been evaluated in mid-stage clinical studies for rheumatoid arthritis and multiple sclerosis. In the rheumatoid arthritis phase 2a trial, the asset was tested in 35 patients for its effect on disease activity compared to baseline.
The study’s primary readout had been scheduled for November of last year. According to the company, the decision to terminate the program was not driven by safety concerns but because the asset did not meet internal criteria for continued development. A separate phase 2a/2b trial in multiple sclerosis is expected to read out in August 2027. The four-year study aimed to enroll 200 patients and was most recently listed as recruiting.
The third discontinued asset is AC-225-PSMA-62, a radioligand therapy studied in a phase 1/2 trial for prostate-specific membrane antigen-positive prostate cancer with limited spread. The trial’s primary readout was scheduled for September 2027. The spokesperson said the therapy did not meet Lilly’s bar for differentiated efficacy to advance to phase 2 and that the decision was not related to any new or unexpected safety findings. When asked about workforce impact, the spokesperson said there were no large-scale workforce reductions underway at the company.
In its most recent quarter, Lilly reported that research and development spending increased 26% to $3.8 billion, representing 20% of revenue. The company has focused on next-generation obesity candidates, including the small-molecule orforglipron. Lilly has received a Commissioner’s National Priority Voucher, which could accelerate the approval decision for orforglipron.
Eli Lilly Cuts clinical-stage Gene Therapy Program
Eli Lilly has announced the discontinuation of three clinical-stage programs, including a gene therapy acquired from Prevail Therapeutics. The program targeted frontotemporal dementia linked to progranulin mutations. While safety concerns were not reported, the company decided to halt development due to insufficient efficacy observed in early-stage trials. (fiercebiotech.com)
Eli Lilly Ends clinical-stage Antibody and Radioligand Programs
In addition to the gene therapy, Eli Lilly is discontinuing an anti-CD19 antibody aimed at autoimmune diseases and a radioligand therapy being tested in prostate cancer. Neither program met the internal benchmarks for clinical-stage development, prompting a strategic reallocation of resources to more promising programs. (clinicaltrialsarena.com)
Eli Lilly Refocuses on High-Priority clinical-stage Research
The discontinuations are part of Eli Lilly’s strategy to optimize its pipeline, focusing on areas such as obesity, diabetes, and genetic medicine. This approach allows the company to prioritize clinical-stage programs with higher differentiation and commercial potential, ensuring that resources are used efficiently. (lilly.com)
Eli Lilly’s Impact on Biotech and Investors
The decision by Eli Lilly has had ripple effects in the biotech sector, influencing investor sentiment regarding mid-stage clinical-stage programs. Analysts view this rationalization as part of a broader industry trend toward pipeline efficiency and risk management. (fiercepharma.com)
Looking Ahead: Eli Lilly’s Pipeline Strategy
Eli Lilly continues to advance several clinical-stage programs in strategic therapeutic areas. By discontinuing underperforming programs, the company is positioning itself to deliver stronger results in its prioritized portfolio, maintaining competitiveness in the global pharmaceutical market. (lqventures.com)
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