Q32 Bio Doses First Patients in Both Part A Open-Label Extension and Part B of SIGNAL-AA Phase 2a Trial Evaluating Bempikibart in Alopecia Areata
Q32 Bio (QTTB) has announced significant progress in its SIGNAL-AA Phase 2a clinical trial for bempikibart in alopecia areata (AA) treatment. The company has dosed first patients in both Part A open-label extension (OLE) and Part B of the trial.
Part A results showed encouraging clinical activity with improvement in SALT scores and SALT-20 responses through week 36. Notable continued responses were observed in multiple patients through week 55, approximately seven months post-last dose, suggesting potential remittive effects and durability of response.
Part B will evaluate approximately 20 severe or very severe AA patients over 36 weeks, with follow-up to 52 weeks. The treatment protocol includes a 200mg weekly loading regimen for four weeks, followed by 200mg every-other-week maintenance doses over 32 weeks. Topline data from Part B is expected in the first half of 2026.
Q32 Bio (QTTB) ha annunciato progressi significativi nel suo studio clinico di fase 2a SIGNAL-AA per il trattamento dell'alopecia areata (AA) con bempikibart. L'azienda ha somministrato le prime dosi ai pazienti sia nella Parte A, estensione in aperto (OLE), sia nella Parte B dello studio.
I risultati della Parte A hanno mostrato un'attività clinica promettente con miglioramenti nei punteggi SALT e nelle risposte SALT-20 fino alla settimana 36. Risposte significative e durature sono state osservate in diversi pazienti fino alla settimana 55, circa sette mesi dopo l'ultima dose, suggerendo effetti potenzialmente remittenti e una buona durata della risposta.
La Parte B valuterà circa 20 pazienti con AA grave o molto grave per 36 settimane, con un follow-up fino a 52 settimane. Il protocollo di trattamento prevede un carico settimanale di 200 mg per quattro settimane, seguito da dosi di mantenimento di 200 mg ogni due settimane per 32 settimane. I dati principali della Parte B sono attesi nella prima metà del 2026.
Q32 Bio (QTTB) ha anunciado avances significativos en su ensayo clínico de fase 2a SIGNAL-AA para el tratamiento de la alopecia areata (AA) con bempikibart. La compañía ha administrado las primeras dosis a pacientes tanto en la Parte A, extensión de etiqueta abierta (OLE), como en la Parte B del ensayo.
Los resultados de la Parte A mostraron una actividad clínica alentadora con mejoras en las puntuaciones SALT y respuestas SALT-20 hasta la semana 36. Se observaron respuestas notables y sostenidas en varios pacientes hasta la semana 55, aproximadamente siete meses después de la última dosis, lo que sugiere posibles efectos remitentes y durabilidad en la respuesta.
La Parte B evaluará aproximadamente a 20 pacientes con AA grave o muy grave durante 36 semanas, con seguimiento hasta 52 semanas. El protocolo de tratamiento incluye una carga semanal de 200 mg durante cuatro semanas, seguida de dosis de mantenimiento de 200 mg cada dos semanas durante 32 semanas. Se esperan los datos principales de la Parte B en la primera mitad de 2026.
Q32 Bio (QTTB)는 원형탈모증(AA) 치료를 위한 SIGNAL-AA 2a상 임상시험에서 중요한 진전을 발표했습니다. 회사는 시험의 파트 A 공개라벨 연장(OLE)과 파트 B에서 첫 환자 투여를 완료했습니다.
파트 A 결과는 SALT 점수와 SALT-20 반응에서 36주차까지 임상적 개선을 보이며 고무적인 활동을 나타냈습니다. 일부 환자에서는 마지막 투여 후 약 7개월인 55주차까지 지속적인 반응이 관찰되어, 잠재적인 관해 효과와 반응의 지속성을 시사합니다.
파트 B는 중증 또는 매우 중증 AA 환자 약 20명을 36주간 평가하며, 52주까지 추적 관찰합니다. 치료 프로토콜은 4주간 매주 200mg의 적재 용량 투여 후 32주간 격주로 200mg 유지 용량을 투여합니다. 파트 B의 주요 데이터는 2026년 상반기에 발표될 예정입니다.
Q32 Bio (QTTB) a annoncé des progrès significatifs dans son essai clinique de phase 2a SIGNAL-AA pour le traitement de l'alopécie areata (AA) avec le bempikibart. La société a administré les premières doses aux patients à la fois dans la Partie A, extension en ouvert (OLE), et dans la Partie B de l'essai.
Les résultats de la Partie A ont montré une activité clinique encourageante avec une amélioration des scores SALT et des réponses SALT-20 jusqu'à la semaine 36. Des réponses notables et durables ont été observées chez plusieurs patients jusqu'à la semaine 55, environ sept mois après la dernière dose, suggérant des effets potentiellement rémissifs et une durabilité de la réponse.
La Partie B évaluera environ 20 patients atteints d'AA sévère ou très sévère sur 36 semaines, avec un suivi jusqu'à 52 semaines. Le protocole de traitement comprend une charge hebdomadaire de 200 mg pendant quatre semaines, suivie de doses d'entretien de 200 mg toutes les deux semaines pendant 32 semaines. Les données principales de la Partie B sont attendues au premier semestre 2026.
Q32 Bio (QTTB) hat bedeutende Fortschritte in seiner SIGNAL-AA Phase 2a klinischen Studie zur Behandlung von Alopecia Areata (AA) mit Bempikibart bekanntgegeben. Das Unternehmen hat die ersten Patienten sowohl in Teil A der offenen Verlängerung (OLE) als auch in Teil B der Studie dosiert.
Die Ergebnisse von Teil A zeigten ermutigende klinische Aktivität mit Verbesserungen der SALT-Werte und SALT-20-Antworten bis Woche 36. Bemerkenswerte anhaltende Reaktionen wurden bei mehreren Patienten bis Woche 55 beobachtet, etwa sieben Monate nach der letzten Dosis, was auf mögliche Remissionswirkungen und eine anhaltende Wirksamkeit hinweist.
Teil B wird etwa 20 Patienten mit schwerer oder sehr schwerer AA über 36 Wochen evaluieren, mit einer Nachbeobachtung bis Woche 52. Das Behandlungsprotokoll sieht eine wöchentliche Ladephase von 200 mg über vier Wochen vor, gefolgt von Erhaltungsdosen von 200 mg alle zwei Wochen über 32 Wochen. Die wichtigsten Daten aus Teil B werden für das erste Halbjahr 2026 erwartet.
- Demonstrated continued patient response 7 months post-treatment, suggesting potential remittive effects
- Strong patient demand and high re-consent rates for continued dosing in Part A extension
- Well-tolerated safety profile reported in clinical trials
- Trial progressing on schedule with clear timeline for topline data
- Final efficacy data not available until 1H 2026
- Small patient population (20) in Part B trial may limit statistical significance
- Requires lengthy treatment period (36 weeks) with frequent dosing
Insights
Q32 Bio's simultaneous dosing in both the open-label extension of Part A and initiation of Part B of the SIGNAL-AA trial represents meaningful clinical advancement for bempikibart in alopecia areata. The reported findings from Part A showing continued response through week 55 (approximately seven months after the last dose) is particularly noteworthy, as most current AA therapies require continuous treatment to maintain efficacy.
The high patient re-consent rates indicate favorable patient experience, while the potential for a remittive effect would significantly differentiate bempikibart in the treatment landscape. Current approved treatments for AA (primarily JAK inhibitors) typically show rapid hair regrowth but require continuous therapy, with relapse common upon discontinuation.
Part B's design features an optimized dosing regimen with a loading dose followed by maintenance dosing over 36 weeks, with extended follow-up through 52 weeks. This approach aims to confirm the durability signals observed in Part A. The primary efficacy endpoints focusing on SALT score improvements at week 36 are clinically relevant, with the SALT-20 response (representing minimal or no visible disease) being particularly meaningful for patients.
While these early signals are encouraging, the sample size remains , and the open-label nature of Part B means results will need confirmation in larger randomized controlled trials. The timeline for topline data in 1H 2026 aligns with typical development timeframes for this indication.
Q32 Bio's clinical progress with bempikibart represents positive execution on their stated development timeline. This milestone confirms operational momentum and suggests their cash runway calculations remain on track. For a clinical-stage biotech with $23.4M market cap, meeting development milestones is critical.
The potential differentiation through durability of response is particularly valuable from a commercial perspective. If confirmed in larger studies, a therapy offering extended response after discontinuation could command premium pricing and potentially capture significant market share in the alopecia areata space, currently dominated by JAK inhibitors like Olumiant (baricitinib) and Litfulo (ritlecitinib).
The company's strategic positioning of bempikibart as potentially "transforming the AA treatment paradigm" hinges on validating these early durability signals in Part B. The decision to conduct an open-label extension for Part A participants suggests confidence in the safety profile, an important consideration for chronic conditions like AA where long-term treatment is often required.
Investor focus should now shift to the 1H 2026 topline data readout as the next major catalyst. While this timeline means no immediate revenue prospects, positive data could trigger partnership interest or accelerate the company's valuation. The high re-consent rates for the extension study provide a qualitative indicator of patient satisfaction, a positive signal for potential market adoption if eventually approved.
-- SIGNAL-AA Part B topline data readout on-track for 1H'26 --
"Dosing the first patients in both the Part A OLE and Part B of our SIGNAL-AA trial highlights our ongoing momentum in the clinical development of bempikibart as a potential treatment for AA," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "Based upon the encouraging clinical activity observed to date, including patients with continued responses in long-term follow-up months after completing treatment, robust pharmacologic data and a well-tolerated safety profile, we believe bempikibart has the potential to transform the AA treatment paradigm as a new and differentiated therapy for patients, if approved."
Q32 previously announced results from Part A of the SIGNAL-AA Phase 2a clinical trial, a randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in adult patients with severe and very severe AA (baseline Severity of Alopecia Tool (SALT) scores of 50-100) treated over 24 weeks, with follow-up through 36 weeks. Results reported to date have demonstrated encouraging clinical activity, including improvement from baseline on SALT score and meaningful achievement of SALT-20 (SALT score less than or equal to 20) response through week 36. Part A of the SIGNAL-AA clinical trial has been completed. Through additional post-clinical trial data collection after 36 weeks, continued responses were observed in multiple patients through week 55, approximately seven months post last dose, along with continued SALT reductions in some patients, despite dosing through only 24 weeks. The Company believes these findings may be suggestive of a remittive effect, durability of response, and a key differentiation from currently approved therapies. Based on re-consent rates and strong patient demand for continued dosing, Q32 Bio initiated the OLE for eligible patients that completed Part A to enable longer-term follow-up of patients.
Part B of the SIGNAL-AA Phase 2a clinical trial is an open-label clinical trial, dosing approximately 20 evaluable severe or very severe AA patients with bempikibart for 36 weeks, with follow-up out to 52 weeks. Dosing will include an initial loading regimen of 200mg of bempikibart dosed weekly over four weeks, 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 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. Q32 Bio expects to report topline data from SIGNAL-AA Part B in the first half of 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
For more information, visit www.Q32Bio.com.
- National Alopecia Areata Foundation
Availability of Other Information About Q32 Bio
Investors and others should note that Q32 Bio communicates with its investors and the public using its website www.Q32Bio.com, including, but not limited to, the Company's disclosures, investor presentations and FAQs, Securities and Exchange Commission (the "SEC") filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that Q32 Bio posts on its website or on X or LinkedIn could be deemed to be material information. As a result, Q32 Bio encourages investors, the media and others interested to review the information that it posts there on a regular basis. The contents of the Company's website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the
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, may not support the Company'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 the first half of 2026 or at all, might be more costly than expected or might not yield anticipated results, and such other risks and uncertainties identified in the Company's periodic, current and other filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024 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 the Company's results of operations and its cash flows, which would, in turn, have a significant and adverse impact on the Company's stock price. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company 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
What are the key findings from SIGNAL-AA Phase 2a Part A trial for QTTB's bempikibart?
What is the dosing schedule for QTTB's bempikibart in SIGNAL-AA Phase 2a Part B?
When will QTTB release topline data for SIGNAL-AA Phase 2a Part B trial?
How many patients will be enrolled in QTTB's SIGNAL-AA Phase 2a Part B trial?
What differentiates QTTB's bempikibart from current alopecia areata treatments?
