Q32 Bio Announces Late-Breaking Presentation of Results from SIGNAL-AA Part A Clinical Trial of Bempikibart in Alopecia Areata at the 2025 American Academy of Dermatology Annual Meeting

Rhea-AI Summary

Q32 Bio (QTTB) announced that results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) will be presented at the 2025 American Academy of Dermatology Annual Meeting in Orlando.

The presentation will highlight findings from the randomized, placebo-controlled trial evaluating bempikibart, a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling in severe and very severe alopecia areata patients.

The late-breaking oral presentation will be delivered by Dr. Brett King of Dermatology Physicians of Connecticut on March 8, 2025. The company views the selection for late-breaking presentation status as recognition of bempikibart's promising clinical activity and well-tolerated safety profile.

Positive

• Selected for late-breaking presentation status at major medical conference
• Promising clinical activity reported in Phase 2a trial
• Well-tolerated safety profile indicated

Negative

• None.

News Market Reaction – QTTB

+1.34%

1 alert

+1.34% News Effect

On the day this news was published, QTTB gained 1.34%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

-- Oral presentation to highlight Phase 2a Part A results of the randomized, placebo-controlled SIGNAL-AA clinical trial evaluating bempikibart in patients with severe and very severe alopecia areata (AA) --

WALTHAM, Mass., Feb. 28, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) will be presented in a late-breaking oral session at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place March 7-11 in Orlando, FL. Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking IL-7 and TSLP signaling for the treatment of AA currently being evaluated in a Phase 2 program.

"We are honored that the Phase 2a SIGNAL-AA data from bempikibart was selected for an oral late-breaking presentation at this year's AAD annual meeting, which provides recognition of its promising clinical activity and well-tolerated safety profile. This acknowledgement reinforces our conviction in bempikibart's potential to transform the treatment paradigm for a disease in desperate need of better options," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "The growing enthusiasm in the field underscores our decision to focus on advancing bempikibart in AA, and we look forward to sharing our results."

Oral Presentation Details:

Title: Initial Results from the SIGNAL-AA Study: Randomized Placebo Controlled Phase 2a Trial of a Bempikibart, Novel IL-7/TSLP Bifunctional Receptor Antagonist in Patients with Severe or Very Severe Alopecia Areata
Presenter: Brett King, M.D., Ph.D., of Dermatology Physicians of Connecticut, and former Associate Professor of Dermatology, Yale University School of Medicine
Session Title: S028 - Late-Breaking Research: Session 1
Date & Time: Saturday, March 8, 2025, from 10:36 a.m. to 10:48 a.m. ET
Location: Chapin Theater – Level II

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 in autoimmune and inflammatory diseases.

Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases being evaluated in a 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.

Availability of Other Information About Q32 Bio

Investors and others should note that we communicate with our investors and the public using our company website www.Q32Bio.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our 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 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, including, among others, our beliefs, observations, expectations and assumptions regarding the topline data from the SIGNAL-AA Phase 2a and the safety, tolerability, clinical activity, potential efficacy and potential benefits of bempikibart; 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, may not support our current beliefs and expectations for bempikibart, future clinical studies, including that 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 U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and any subsequent filings with the Commission, 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. We caution 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
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-announces-late-breaking-presentation-of-results-from-signal-aa-part-a-clinical-trial-of-bempikibart-in-alopecia-areata-at-the-2025-american-academy-of-dermatology-annual-meeting-302388185.html

SOURCE Q32 Bio

FAQ

What are the key findings from Q32 Bio's SIGNAL-AA Phase 2a trial of bempikibart (QTTB)?

The specific trial results will be presented at the AAD Annual Meeting on March 8, 2025. The company indicates promising clinical activity and well-tolerated safety profile.

How does bempikibart work in treating alopecia areata?

Bempikibart is an anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking IL-7 and TSLP signaling in alopecia areata patients.

When and where will Q32 Bio (QTTB) present the SIGNAL-AA trial results?

The results will be presented on March 8, 2025, at 10:36 AM ET during the AAD Annual Meeting in Orlando, FL, in the Chapin Theater.

What phase of clinical development is bempikibart currently in for alopecia areata?

Bempikibart is currently being evaluated in a Phase 2 program, with these results coming from Part A of the Phase 2a SIGNAL-AA trial.