Q32 Bio Announces Completion of Enrollment in Part B of SIGNAL-AA Phase 2a Clinical Trial of Bempikibart for Alopecia Areata
Q32 Bio (NASDAQ: QTTB) completed enrollment in Part B of its SIGNAL-AA Phase 2a trial of bempikibart for severe or very severe alopecia areata on Oct 21, 2025. Total enrollment reached 33 patients, exceeding an initial ~20-patient target due to patient demand. Part B uses a 200mg loading regimen (weekly x4) then 200mg every-other-week to 36 weeks, with follow-up to 52 weeks.
Early-enrolling patients show emerging clinical activity; preliminary PK indicates steady state is achieved about 9 weeks earlier versus Part A. Topline data are expected in mid-2026.
Q32 Bio (NASDAQ: QTTB) ha completato l'arruolamento nella Parte B della sua sperimentazione SIGNAL-AA di fase 2a di bempikibart per alopecia areata severa o molto severa il 21 ottobre 2025. L'arruolamento totale ha raggiunto 33 pazienti, superando l'obiettivo iniziale di ~20 pazienti a causa della domanda dei pazienti. La Parte B usa un regime di caricamento 200 mg (settimanale x4) quindi 200 mg ogni due settimane fino a 36 settimane, con follow-up fino a 52 settimane.
I pazienti che si arruolano precocemente mostrano un'attività clinica emergente; i dati farmacocinetici preliminari indicano che lo stato stazionario si raggiunge circa 9 settimane prima rispetto alla Parte A. I dati principali sono attesi a metà 2026.
Q32 Bio (NASDAQ: QTTB) completó el reclutamiento en la Parte B de su ensayo de fase 2a SIGNAL-AA de bempikibart para alopecia areata severa o muy severa el 21 de octubre de 2025. El reclutamiento total alcanzó 33 pacientes, superando el objetivo inicial de ~20 pacientes debido a la demanda de los pacientes. La Parte B utiliza un régimen de carga de 200 mg (semanal x4) luego 200 mg cada dos semanas hasta 36 semanas, con seguimiento hasta las 52 semanas.
Los pacientes que se inscriben temprano muestran actividad clínica emergente; los datos farmacocinéticos preliminares indican que el estado de equilibrio se alcanza alrededor de 9 semanas antes frente a la Parte A. Se esperan los datos principales a mediados de 2026.
Q32 Bio (NASDAQ: QTTB)는 2025년 10월 21일에 bempikibart의 심각하거나 매우 심한 탈모증 alopecia areata에 대한 SIGNAL-AA 2상 2a 시험의 파트 B 등록을 완료했다. 총 등록 수는 33명으로, 초기 목표인 약 20명을 넘어 환자 수요로 인해 증가했다. 파트 B는 200mg 로딩 요법을 주당 1회로 4주 간 시행한 뒤, 36주까지 매주가 아닌 격주로 200mg을 투여하고, 52주까지 추적 관찰한다.
조기에 등록한 환자들은 초기 임상 활력을 보이고 있으며, 예비 약동학(PK) 결과는 Part A에 비해 정착 상태가 약 9주 빨리 달성됨을 시사한다. 주요 데이터는 2026년 중반에 발표될 예정이다.
Q32 Bio (NASDAQ: QTTB) a terminé le recrutement dans la Partie B de son essai SIGNAL-AA de phase 2a sur bempikibart pour l'alopecia areata sévère ou très sévère le 21 octobre 2025. Le recrutement total a atteint 33 patients, dépassant l'objectif initial d'environ 20 patients en raison de la demande des patients. La Partie B utilise un régime de charge de 200 mg (toutes les semaines x4), puis 200 mg toutes les deux semaines jusqu'à 36 semaines, avec un suivi jusqu'à 52 semaines.
Les patients qui s'inscrivent tôt montrent une activité clinique émergente; les premières données PK indiquent que l'état d'équilibre est atteint environ 9 semaines plus tôt que dans la Partie A. Les données en tête de liste (topline) sont attendues à mi-2026.
Q32 Bio (NASDAQ: QTTB) hat die Rekrutierung in Teil B seiner SIGNAL-AA Phase-2a-Studie von bempikibart zur schweren oder sehr schweren Alopecia areata am 21. Oktober 2025 abgeschlossen. Die Gesamtrekrutierung erreichte 33 Patienten, mehr als das anfängliche Ziel von ca. 20 Patienten aufgrund der Patientennachfrage. Teil B verwendet ein 200 mg Lade-Regime (wöchentlich x4) dann 200 mg alle zwei Wochen bis zu 36 Wochen, mit Nachbeobachtung bis 52 Wochen.
Früh eingeschriebene Patienten zeigen eine aufkommende klinische Aktivität; vorläufige PK-Daten deuten darauf hin, dass der Gleichgewichtszustand etwa 9 Wochen früher erreicht wird als in Teil A. Die Topline-Daten werden voraussichtlich Mitte 2026 veröffentlicht.
Q32 Bio (NASDAQ: QTTB) أكمل تسجيله في الجزء ب من تجربة المرحلة 2a SIGNAL-AA لـ bempikibart لعلاج الثعلبة الناجمة عن الثعلبة الشديدة أو الشديدة جدًا في 21 أكتوبر 2025. وصل إجمالي التسجيل إلى 33 مريضاً، متجاوزاً الهدف الأولي نحو ~20 مريضاً بسبب الطلب من المرضى. الجزء B يستخدم نظام تحميل 200 ملغ (أسبوعياً x4) ثم 200 ملغ كل أسبوعين حتى 36 أسبوعاً، مع متابعة حتى 52 أسبوعاً.
المرضى المُسجّلين مبكراً يظهرون نشاطاً سريرياً ناشئاً؛ تشير بيانات PK الأولية إلى أن حالة الاتزان تتحقق نحو 9 أسابيع مبكراً مقارنة بالجزء A. من المتوقع الحصول على البيانات الأساسية في منتصف 2026.
Q32 Bio (NASDAQ: QTTB) 已完成其 SIGNAL-AA 第2a阶段试验中对 bempikibart 的 Part B 的招募，适用于严重或极严重的斑秃，日期为 2025 年 10 月 21 日。总招募达到 33 例患者，超出了最初约 20 例患者的目标，原因是患者需求。Part B 采用 200 mg 负荷方案（每周 x4），然后每两周 200 mg，直至 36 周，随访至 52 周。
早期入组患者显示出初步临床活性；初步药代动力学（PK）数据显示，相较于 Part A，达到稳态大约提前 9 周。首要数据预计于 2026 年中公布。
- Enrollment exceeded target: 33 patients vs ~20 planned
- Faster PK steady state: ~9 weeks earlier with loading regimen
- Topline data timing: topline readout expected mid-2026
- Open-label design in Part B
- Modest sample size: total enrollment of 33 patients
Insights
Q32 completed over-enrollment in SIGNAL-AA Part B and expects topline data in mid-2026; early PK and activity signals reported.
Enrollment rose to 33 patients, above the original ~20 target, and Part B uses a loading regimen followed by every-other-week maintenance dosing through
Key dependencies and risks include the open-label design, small sample size, and need for clear, robust SALT improvements and safety data to justify pivotal advancement. The announced earlier steady state is a pharmacologic observation, not an efficacy proof; safety, magnitude of response at week
-- SIGNAL-AA Part B exceeded target enrollment based on demand from patients; trial size increased to 33 patients --
"We are pleased to complete enrollment and exceed our initial enrollment target in Part B of the SIGNAL-AA trial, which reflects our team's capabilities to execute our clinical development plan and the strong interest from patients and their healthcare providers in bempikibart's IL-7Rα antagonist approach in AA," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "In SIGNAL-AA Part A, bempikibart demonstrated encouraging clinical activity, a well-tolerated safety and tolerability profile, and expected on-mechanism changes in T-cells, indicative of potent IL-7 inhibition. Part B, which includes a loading regimen and dosing through 36 weeks, is intended to build upon these findings as we advance bempikibart in AA."
Ms. Morrison added, "Patients with AA are in need of new, safer, and more durable treatment alternatives to currently approved agents, and this milestone underscores our commitment to advancing bempikibart as a potentially differentiated therapeutic option. We look forward to sharing topline data from Part B of the SIGNAL-AA trial next year, which, pending the results, could support advancement into pivotal trials upon completion."
The Part B portion of SIGNAL-AA is an open-label clinical trial dosing severe or very severe AA patients with a maximum duration of current episode of four years. Patients will be treated with bempikibart for 36 weeks, with follow-up out to 52 weeks. Dosing includes an initial loading regimen of 200mg of bempikibart dosed weekly for four doses, followed by a maintenance dose of 200mg every-other-week over a 32-week period for a total dosing period of 36 weeks. Efficacy will be evaluated on the basis of mean percentage change from baseline in Severity of Alopecia Tool (SALT) scores as well as the proportion of subjects achieving various relative and absolute SALT improvements at week 36, with follow-up through week 52. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results.
Emerging signs of clinical activity are being observed amongst the early-enrolling patients in Part B of the trial. In addition, based on preliminary pharmacokinetic data available to date in the Part B portion of SIGNAL-AA, steady state concentration of drug in patients is achieved at least nine weeks earlier as compared to Part A of the clinical trial due to the inclusion of the loading regimen, which may have the potential to induce earlier responsiveness.
Total enrollment of 33 patients exceeded the initial target of approximately 20 patients due to demand from patients and their healthcare providers. As a result of the over-enrollment, Q32 Bio expects to report topline data from SIGNAL-AA Part B in mid-2026.
About Q32 Bio
Q32 Bio is a clinical stage biotechnology company whose science targets potent regulators of the adaptive immune system to re-balance immunity and is focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases. About 700,000 people in the United States live with alopecia areata1, a disease which has a life-altering impact on patients and limited current treatment options. Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function, for the treatment of alopecia areata in an ongoing Phase 2 program. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases.
For more information, visit www.Q32Bio.com.
1National Alopecia Areata Foundation
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Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements contained herein which do not describe historical facts are forward-looking statements, including, among others, Q32 Bio's beliefs, observations, expectations and assumptions regarding the plan, purpose and timing of Part B of the SIGNAL-AA Phase 2a clinical trial and the anticipated timing of its data, the safety, tolerability, clinical activity, durability, potential efficacy and potential benefits of bempikibart, and Q32 Bio's beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Forward-looking statements are based on management's current beliefs and assumptions, which are subject to risks and uncertainties and are not guarantees of future performance. Such risks and uncertainties include, among others, the risk that additional data, or the results of ongoing data analyses including emerging signs of clinical activity and pharmacokinetic data available to-date from early-enrolling patients in Part B of the SIGNAL-AA Phase 2a clinical trial, may not support Q32 Bio's current beliefs and expectations for bempikibart, including with respect to the durability of clinical responses, the risk that ongoing and future clinical studies, including Part B of the SIGNAL-AA Phase 2a clinical trial, may not be completed by mid-2026 or at all, might be more costly than expected or might not yield anticipated results, that Q32 Bio may use its capital resources sooner than currently anticipated and such other risks and uncertainties identified in Q32 Bio's periodic, current and other filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and any subsequent filings with the SEC, which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect Q32 Bio's results of operations and its cash flows, which would, in turn, have a significant and adverse impact on Q32 Bio's stock price. Q32 Bio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Q32 Bio disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
Contacts:
Investors: Brendan Burns
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
Media: David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com
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SOURCE Q32 Bio
FAQ
How many patients were enrolled in QTTB SIGNAL-AA Part B and when was enrollment completed?
What is the bempikibart dosing schedule in SIGNAL-AA Part B (QTTB)?
When does Q32 Bio expect topline SIGNAL-AA Part B data for QTTB?
What efficacy measures will SIGNAL-AA Part B use for QTTB?
Did SIGNAL-AA Part B show any early signs of activity for QTTB?
How did the loading regimen affect bempikibart pharmacokinetics in SIGNAL-AA Part B?
