Chugai reported Phase I/II NXTAGE data showing favorable safety and tolerability of NXT007 in hemophilia A patients switching directly from emicizumab without a washout period.
Written By: Pharmacally Medical News Desk
Chugai Pharmaceutical reported new clinical data for its investigational bispecific antibody NXT007 at the 2026 European Association for Haemophilia and Allied Disorders Congress in Ireland. The findings mark the first evaluation of patients transitioning directly from emicizumab without a washout period.
NXTAGE study
Part C of the Phase I/II NXTAGE study evaluated NXT007 in adolescents and adults aged 12 to under 65 years with hemophilia A, with or without factor VIII inhibitors, who had been receiving continuous emicizumab therapy for at least 12 weeks. In this multiple ascending dose segment, participants were assigned to four cohorts and transitioned directly to subcutaneous NXT007 without a washout period. Following a 4 to 6 week loading phase, patients received maintenance dosing every four weeks at cohort-specific dose levels. The interim analysis included 14 participants, with at least three patients per cohort treated for 16 weeks or longer.
Key Findings
NXT007 showed favourable tolerability during the switch. No thromboembolic events were reported, adverse events did not increase with higher doses, and no treatment discontinuations or NXT007-related serious adverse events occurred.
Injection site reactions were the most common treatment-related events, observed in 14.3% of participants, all are mild.
Anti-drug antibodies affecting plasma concentrations were detected in one participant in Cohort C-3; however, drug levels remained stable, and the patient continued treatment without bleeding episodes.
Pharmacokinetic findings demonstrated dose-dependent increases in NXT007 exposure. Consistent with earlier observations in emicizumab-naïve patients, the highest dose cohorts (C-3 and C-4) achieved plasma concentrations predicted from nonclinical models to deliver factor VIII-equivalent activity within the normal range.
No bleeding-related treatments were required in the higher-dose cohorts after switching to NXT007.
Chugai stated that the findings support the safety and tolerability of switching from emicizumab to NXT007 without a washout period, a key consideration for clinical practice. The company, working with Roche, plans to initiate three Phase III studies this year, advancing its goal of achieving hemostatic control comparable to individuals without hemophilia.
About NXT007
NXT007 is Chugai’s investigational bispecific antibody developed for hemophilia A. The molecule is engineered to simultaneously engage activated factor IX and factor X, thereby replicating the functional role of factor VIII. NXT007 incorporates Chugai’s FAST-Ig™ and ACT-Ig® antibody engineering platforms, which were applied to refine the Hemlibra-based structure and improve both potency and pharmacokinetic behaviour. Roche obtained global rights to NXT007 through an in-licensing agreement in 2022. Clinical development remains underway in Phase I/II trials, and three Phase III studies are scheduled to start in 2026.
Reference
NXT007 Suggests Favorable Tolerability and Efficacy in Phase I/II Study for Hemophilia A Following Direct Switch from Emicizumab without Washout Period, 09 February 2026, Feb 09,2026 | NXT007 Suggests Favorable Tolerability and Efficacy in Phase I/II Study for Hemophilia A Following Direct Switch from Emicizumab without Washout Period | News | CHUGAI PHARMACEUTICAL CO., LTD.