Q32 Bio Announces Q3 2024 Results and Highlights Clinical Progress of Bempikibart and ADX-097
Key Insights
Q32 Bio's bempikibart Phase 2 trials in atopic dermatitis (search) and alopecia areata (search) are on track, with topline results expected in December 2024.
Enrollment is ongoing in the ADX-097 Phase 2 basket trial for complement-mediated renal diseases, with initial data expected in H1 2025.
The company’s cash and equivalents, totaling $89.1 million, are projected to fund operations through multiple Phase 2 milestones into mid-2026.
Q32 Bio Inc. (Nasdaq: QTTB) reported its financial results for the third quarter of 2024, alongside updates on its clinical programs. The company's focus remains on advancing its Phase 2 clinical trials for bempikibart in atopic dermatitis (search) (AD) and alopecia areata (search) (AA), with topline data expected in December 2024. Additionally, enrollment continues in the Phase 2 basket trial of ADX-097 for complement-mediated renal diseases.
Bempikibart Phase 2 Trials
The SIGNAL-AD trial, a Phase 2 study evaluating bempikibart in adults with moderate-to-severe AD, has completed enrollment with 121 patients. The primary endpoint is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score. Topline results are anticipated in December 2024.
Similarly, the SIGNAL-AA trial, a Phase 2 study of bempikibart in patients with severe AA, is also on track for topline results in December 2024. This trial randomizes patients 3:1 to bempikibart 200 mg Q2W SC or placebo, with the primary endpoint being the mean percent change from baseline on the Severity of Alopecia Tool (SALT) score at week 24.
ADX-097 Development
ADX-097, a tissue-targeted inhibitor of complement activation, is currently being evaluated in a Phase 2 basket trial for complement-mediated renal diseases, including IgA Nephropathy (search) (IgAN), Lupus Nephritis (search) (LN), and C3 Glomerulopathy (search) (C3G). Initial open-label data is expected in the first half of 2025, with topline results anticipated in the second half of 2025. Furthermore, Q32 Bio plans to initiate a Phase 2 trial of ADX-097 in ANCA-Associated Vasculitis (search) (AAV) in the first half of 2025.
Positive Phase 1 clinical trial results for ADX-097 were presented at ASN Kidney Week 2024, demonstrating a favorable safety profile and PK/PD properties that support tissue inhibition of complement in glomerular diseases while sparing systemic complement activity.
Financial Position
As of September 30, 2024, Q32 Bio reported cash and cash equivalents of $89.1 million, which the company believes is sufficient to fund operations into mid-2026, through multiple Phase 2 clinical milestones. Research and development expenses for the third quarter of 2024 were $14.3 million, compared to $7.5 million for the same period in 2023. The net loss for the quarter was $17.6 million, or $1.46 per share.
"We believe bempikibart has the potential to bring a differentiated, disease-modifying treatment to patients with AD and AA and look forward to sharing our results," said Jodie Morrison, Chief Executive Officer of Q32 Bio.