CAMBRIDGE, Mass.— LifeMine Therapeutics, a clinical-stage biopharmaceutical company known for its innovative drug discovery platform using fungal genomics, has announced that the first participant has been dosed in its Phase 1 clinical trial of LIFE-001. The trial marks a key milestone in the development of what the company believes could be a “field-dominating” immunosuppressive therapy.
LIFE-001 is a next-generation calcineurin inhibitor (CNi), designed from the ground up to overcome the limitations of current treatments in this class. Traditionally, CNis have been used to prevent organ rejection in transplant patients and to treat immune-mediated conditions. However, existing CNis are associated with significant side effects due to their reliance on immunophilin binding, which often leads to organ toxicity and requires rigorous blood monitoring.
LifeMine aims to change that with LIFE-001. In preclinical models, the drug has demonstrated enhanced safety, greater convenience through long-acting injectable delivery, and promising efficacy in diseases such as ulcerative colitis and Crohn’s disease.
“This fundamentally reinvented, immunophilin-independent drug has the potential to become the go-to universal immunosuppressant,” said Gregory Verdine, Ph.D., Co-founder, President, and CEO of LifeMine. “LIFE-001 not only sidesteps the safety drawbacks of legacy CNis but also offers advantages over newer biologic treatments.”
Chief Medical Officer Dr. Simon Cooper added that the drug’s predictable exposure, reduced need for blood monitoring, and improved tolerability could make it a best-in-class option for both physicians and patients. “We are excited to begin this first clinical study and aim to advance LIFE-001 as quickly as possible,” he said.
The Phase 1 trial will be conducted in two parts: Phase 1a will focus on evaluating safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) through single and multiple ascending doses in around 100 healthy adults. Phase 1b will then assess the preliminary efficacy of LIFE-001 in patients with immune-mediated diseases, starting with ulcerative colitis.
This trial marks LifeMine’s official entry into the clinical stage, underscoring the company’s unique approach to drug development through its proprietary Top-Down Drug Discovery™ platform, which mines fungal genomes for new therapeutic candidates.
With LIFE-001, LifeMine is positioning itself to reshape the immunosuppressive treatment landscape across a wide range of conditions.
