First successful clinical use of antifibrotic therapy for breast cancer shown in Phase 2 study

Positive study enables valuable repositioning of new antifibrotic drug candidates by a growing number of pharma companies

SAN DIEGO, Oct. 17, 2024 – MeCo Diagnostics, a promising startup focused on innovative cancer treatments, has announced significant findings published in Clinical Cancer Research, the prestigious journal of the American Association for Cancer Research (AACR). The publication outlines a successful Phase 2 clinical trial involving 130 breast cancer patients. This trial was conducted in partnership with the Spanish National Cancer Research Centre (CNIO) and followed a pre-established protocol to assess long-term survival outcomes after antifibrotic therapy.

The study introduces the MeCo Score as the first clinically validated biomarker capable of predicting responses to antifibrotic therapy, offering a novel strategy for combating breast cancer. Patients with early-stage, HER2-negative breast cancer who had High MeCo Scores and were treated with nintedanib (an antifibrotic drug) in combination with chemotherapy showed a 62% reduction in the risk of cancer recurrence compared to those who received only chemotherapy. This outcome was observed over a median follow-up period of 9.7 years (P<0.05).

The impressive and sustained benefit seen with antifibrotic therapy underlines its potential among FDA-approved targeted therapies for breast cancer, particularly for the large subset of patients with HER2-negative tumors. Notably, patients with Low MeCo Scores did not experience the same benefits from the antifibrotic therapy, highlighting the MeCo Score's critical role in identifying suitable candidates for this treatment approach.

Dr. Adam Watson, CEO of MeCo Diagnostics, commented on the study's impact, noting that the research began over a decade ago, aligning fortuitously with the trial’s inception. The resulting data demonstrates that High MeCo Score patients who received a brief course of antifibrotic therapy saw significant improvements in their long-term survival rates.

As nintedanib is poised to become a generic drug, its integration into clinical practice could offer considerable financial benefits to both patients and healthcare providers. Plans for a larger, definitive trial are underway to validate these findings further. If confirmed, the MeCo Score could pave the way for the first affordable, low-toxicity targeted therapy approved for breast cancer. Additionally, the MeCo Score's drug-agnostic design enables the repositioning of any antifibrotic drug for breast cancer treatment, including potential future candidates that may surpass nintedanib in efficacy.

The study's success provides a critical proof of concept for this class of drugs, which is under active development by numerous pharmaceutical companies. The findings suggest that the MeCo Score could be a transformative tool in the therapeutic landscape for breast cancer, guiding the use of antifibrotic treatments to improve patient outcomes.

MeCo Diagnostics Holdings, Inc. is a nascent yet dynamic company based in San Diego, CA, dedicated to creating pioneering predictive biomarkers to enhance the effectiveness of antifibrotic therapies in cancer treatment.