Artios Announces First Patient Dosed in Randomized Phase 2 POLKA Study Evaluating DNA Polymerase Theta Inhibitor ART6043 in gBRCA-mutated HER2-Negative Breast Cancer
Key milestone positions ART6043 as the most advanced Pol-theta inhibitor in clinical development; the potentially first-in-class program is supported by U.S. FDA Fast Track designation
CAMBRIDGE, United Kingdom and NEW YORK, May 26, 2026 – Artios Pharma Limited (“Artios” or “the Company”), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, today announced the dosing of the first patient in a randomized Phase 2 clinical trial (NCT05898399). The global study is evaluating Artios’ potential first-in-class DNA Polymerase Theta (Polθ) inhibitor, ART6043, in combination with the PARP inhibitor olaparib, in adult patients with germline BRCA-mutated (gBRCAm) HER2-negative breast cancer who are eligible to receive a PARP inhibitor.
The Phase 2 POLKA trial is supported by Phase 1/2a clinical data for ART6043, which show an attractive tolerability profile, expected PK/PD activity, and promising clinical signals. The POLKA trial is designed to investigate the safety and tolerability of ART6043 plus olaparib and to evaluate the preliminary efficacy of the combination compared to olaparib alone. Artios was granted a Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2026 for the combination treatment regimen in this patient population. The supporting Phase 1/2a data were presented at the 2025 European Society of Medical Oncology (ESMO) Congress.
“Dosing the first patient in the Phase 2 POLKA study marks a significant step in realizing the potential of ART6043 and advancing a new class of targeted therapies for patients with gBRCAm HER2-negative breast cancer,” said Ian Smith, Chief Medical Officer of Artios. “Patients continue to face limited effective treatment options, underscoring the need for new therapies beyond current standards of care. With Fast Track designation and this study now underway, we are focused on establishing ART6043 as a potential first‑in‑class therapy that can deliver more meaningful benefits for patients.”
“While PARP inhibitors have become a cornerstone of treatment for HER2-negative breast cancer, there remains a significant need for more effective combination strategies to overcome resistance,” added Graeme Smith, Chief Scientific Officer of Artios. “By targeting the complementary DNA repair pathway mediated by Polθ, ART6043 is rationally designed to enhance the cancer cell killing activity of PARP inhibition and to potentially prevent the emergence of resistance to PARP inhibition. We look forward to evaluating this in the Phase 2 POLKA study.”
The global, multicentre, Phase 2 trial is enrolling 80 patients randomized 1:1 with gBRCAm HER2-negative, locally advanced or metastatic breast cancer who received up to three prior lines of chemotherapy and no or ≤ 1 month of prior treatment with a PARP inhibitor. Eligible patients will be assigned to receive ART6043 plus olaparib or olaparib alone to assess comparative efficacy as measured by the primary endpoint, progression-free survival. Secondary endpoints include overall response rate, overall survival, and a comparison of the rate of BRCA mutation reversion.
About ART6043
ART6043 is a potential first-in-class, selective, orally bioavailable, small‑molecule inhibitor of the polymerase domain of DNA polymerase theta (Polθ), a DNA repair enzyme that is preferentially expressed in cancer cells but is virtually absent in most healthy tissues. By inhibiting Polθ, ART6043 targets microhomology-mediated end joining (MMEJ) to exploit tumor dependence on error-prone DNA repair, with broad rationale for use as a combination partner with PARP inhibition and other DNA‑damaging modalities. Artios’ differentiated approach is to evaluate ART6043 with olaparib in molecularly defined solid tumors such as gBRCAm cancers. The Phase1/2a study of ART6043 highlighted an attractive tolerability profile in combination with the leading PARP inhibitor olaparib, expected PK/PD activity, and promising clinical signals.
About Artios Pharma Ltd.
Artios’ mission is to develop new classes of medicines that harness DNA Damage Response (DDR) pathways, targeting DNA replication stress and synthetic lethality, to deliver meaningful survival benefits for patients with cancer. Its three potentially first-in-class programs, each with a novel mechanism of action, include ATR inhibitor alnodesertib, the DNA polymerase theta (Polθ) inhibitor ART6043, and a preclinical portfolio of DDRi-ADC candidates with novel payloads. Together, these programs are designed to eliminate cancer cells’ survival mechanisms, driving cancer cell death and improving clinical outcomes.
Visit our website at www.artios.com to learn more about Artios.
For more information, please contact:
Trophic Communications
Jacob Verghese or Verena Schossmann
Tel: +49 151 219 412 77
Email: artios@trophic.eu
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