Chugai Presents Phase I/II Data on NXT007 Switch from Hemlibra Without Washout

Chugai Presents Phase I/II Data on NXT007 Switch from Hemlibra Without Washout

By, Admin 12 February 2026

Chugai Pharmaceutical has presented new data from Part C of the Phase I/II NXTAGE study evaluating NXT007, a next-generation bispecific antibody for haemophilia A.

The data, unveiled at the 2026 EAHAD Congress in Ireland, represent the first clinical evidence assessing direct switching from emicizumab (Hemlibra) to NXT007 without a washout period.

Why the Switching Data Matters?

Hemlibra is widely used in haemophilia A, making transition strategies critical for next-generation therapies.

Key finding:

Patients were able to switch directly from emicizumab to NXT007 without a washout period, with favourable tolerability.

This is strategically important because:

  • Washout periods introduce bleeding risk
  • Switching barriers slow adoption
  • Seamless transition improves real-world feasibility

Study Design Snapshot: Part C (Switch Cohort)

  • Phase I/II, multicentre
  • Patients aged 12 to <65 years
  • With or without factor VIII inhibitors
  • Minimum 12 weeks prior emicizumab treatment
  • Switched directly to subcutaneous NXT007

Structure:

  • 4 cohorts
  • 4–6 week loading phase
  • Maintenance dosing every 4 weeks
  • Analysis after ≥16 weeks of treatment
  • Total participants: 14

Safety Outcomes

NXT007 was well tolerated during the switch:

  • No thromboembolic events
  • No dose-dependent increase in adverse events
  • No treatment discontinuations
  • No NXT007-related serious adverse events

Most common related adverse event:

  • Injection site reactions (14.3%), all mild

Anti-drug antibodies were detected in one participant (7.1%), but:

  • Plasma levels remained stable
  • No bleeding events occurred
  • Treatment continued

Efficacy Signals

  • Plasma concentrations increased dose-dependently
  • Highest dose cohorts achieved levels potentially equivalent to normal factor VIII activity (based on nonclinical data)
  • No treated bleeds observed in the highest dose cohorts after switching

The ambition is clear: move beyond bleed prevention toward near-normal haemostatic function.

What Makes NXT007 Different?

NXT007 is a bispecific antibody designed to:

  • Bind factor IXa and factor X
  • Mimic the cofactor function of factor VIII
  • Provide subcutaneous administration every four weeks

It builds on Hemlibra but incorporates Chugai’s proprietary technologies:

  • FAST-Ig2 – Optimized variable region to enhance efficacy
  • ACT-Ig3 – Improved pharmacokinetics

Roche in-licensed NXT007 in 2022 and is co-developing the program.

Competitive Context

Hemlibra transformed haemophilia A care by replacing frequent factor VIII infusions with subcutaneous dosing.

NXT007 aims to:

  • Improve coagulation activity toward normal levels
  • Maintain convenient dosing
  • Offer seamless switching from Hemlibra

If Phase III confirms these early findings, NXT007 could represent:

  • A lifecycle evolution of Hemlibra
  • A premium next-generation biologic
  • A defensive move to protect Roche/Chugai’s haemophilia franchise

What’s Next?

Three Phase III trials are planned to begin in 2026. The development goal, according to Chugai’s CEO, is ambitious: To achieve haemostatic function comparable to individuals without haemophilia.

Strategic Takeaway

NXT007 is not a competitor to Hemlibra — it is a potential successor. The ability to switch without washout lowers adoption friction. If higher coagulation normalization translates into fewer microbleeds and improved joint outcomes, NXT007 could reset expectations in haemophilia A management.

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