Q32 Bio has put a stop to a Phase II trial of its former lead renal disease candidate as it pivots focus over to its alopecia areata treatment, bempikibart, amid a corporate restructure and job cuts.
The US-based company has announced that it has officially cancelled its Phase II renal basket trial (NCT06419205) for its humanised anti-C3d mAb fusion protein, ADX-097. Instead, it plans to initiate an open-label extension of its Phase II SIGNAL-AA trial (NCT06018428).
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The decision comes as the company announced a corporate restructuring that will see an unstated number of job cuts across the company. It has also announced that it is examining its strategic options when it comes to its tissue-targeted complement inhibitor platform, including ADX-097.
Q32 Bio CEO Jodie Morrison said: “We have the conviction that bempikibart is differentiated from existing alopecia areata therapies and has the potential to transform the treatment paradigm for this disease.
“This is based on the continued emergence of bempikibart data in alopecia areata patients with longer-term follow-up from part A of the SIGNAL-AA Phase IIa clinical trial, the robust pharmacologic data, and a well-tolerated safety profile.”
Citing strong re-consent rates and patient demand for continued dosing, Q32 Bio plans to launch the open-label extension in the first half of 2025. Formally known as ADX-914, the company secured the worldwide rights to commercialise bempikibart from Amgen in 2023. Under the agreement, Q32 Bio received $55m in initial consideration and staged development funding for the completion of the drug’s two ongoing Phase II trials.
Research by GlobalData’s Pharmaceutical Intelligence Center details that bempikibar, assuming it receives regulatory clearance, is on track to generate $13m in global sales by the end of 2028. This is estimated to rise to $298m by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
Morrison added: “While this restructuring is a very difficult decision, it is a necessary step in the context of the evolving complement-mediated renal disease landscape and as we prioritise our focus and capital to maximise the potential of bempikibart.”
The restructuring comes at something of a low point for Q32 Bio, with its overall stock value having taken a sharp drop in December, dropping from $24.41 a share on 10 December down to $3.18 a share at the time of publication. This pales in comparison to the company’s share value of $48 a share in October 2023.
Elsewhere in the field of hair loss treatment, Eirion Therapeutics has announced positive results from its ‘first-in-man’ trial of topical hair loss treatment that saw a six-fold benefit over a placebo. Meanwhile, Chinese biopharmaceutical company Technoderma Medicines has reported data from its Phase IIa trial of a small molecule drug candidate known as TDM-105795.
