Novartis' Oral Drug For Chronic Skin Disease Candidate Shows Efficacy, Long-term Safety

On Friday, Novartis AG NVS released new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective Bruton's tyrosine kinase (BTK) inhibitor, in chronic spontaneous urticaria (CSU).

CSU is a common and distressing skin condition that causes red, raised, itchy, and sometimes painful hives or wheals (raised rash or patches) on the skin with no known obvious trigger.

In Phase 3 studies, REMIX-1 and REMIX-2, remibrutinib treatment showed significant early symptom improvement, sustained up to Week 52, in patients with CSU who remained symptomatic despite second-generation H1-antihistamine use.

New long-term Phase III REMIX-1 and REMIX-2 data assessed at Week 52 show:

• Significant improvements with remibrutinib versus placebo, as previously shown at Week 12, were confirmed at Week 24, including in weekly urticaria activity score (UAS7), weekly itch severity score (ISS7), and weekly hive severity score (HSS7).
• At Week 24, patients receiving a placebo were transitioned to remibrutinib; responses with remibrutinib were observed as early as the first week after switching and were sustained until the end of the study (28 weeks of treatment).
• Almost half of the patients were completely free of itch and hives (UAS7=0), as assessed at Week 52.

Remibrutinib was well-tolerated and demonstrated a favorable and consistent safety profile up to 52 weeks, including balanced liver function tests versus placebo.

Novartis will submit remibrutinib for approval in CSU to global health authorities starting in H2 2024.

Concurrently, Novartis presented Phase 3 ASC4FIRST trial results at the 2024 American Society of Clinical Oncology meeting.

Scemblix (asciminib) demonstrated superior major molecular response (MMR) rates at week 48 compared to investigator-selected standard-of-care (SoC) tyrosine kinase inhibitors (TKIs) imatinib, nilotinib, dasatinib and bosutinib, and compared to imatinib alone in newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

Scemblix demonstrated MMR rates at week 48 vs. investigator-selected SoC TKIs (67.7% vs. 49.0%) and imatinib alone (69.3% vs. 40.2%). 

Scemblix also showed a numerical improvement in MMR at week 48 vs. second-generation TKIs (nilotinib, dasatinib, and bosutinib).

Additionally, Scemblix demonstrated a favorable safety and tolerability profile, with fewer adverse events and treatment discontinuations.

Price Action: NVS shares are up 2% at $102.74 at last check Friday.

Image generated using artificial intelligence via Midjourney.