Zura Bio (NASDAQ:ZURA) outlined its near-term clinical milestones and strategy at Guggenheim Securities’ Emerging Outlook Biotech Summit 2026, emphasizing upcoming Phase 2 readouts for its lead bispecific antibody, tibulizumab, in autoimmune and inflammatory diseases.
New CEO highlights shift toward upcoming clinical data
Newly appointed Chief Executive Officer Sandeep Kulkarni said he joined the company two weeks prior to the event after a long involvement with Zura as a co-founder and board member since 2022. Kulkarni described the current period as a transition “from being an execution company to being a data company,” with two Phase 2 readouts expected over the next 12–18 months.
Tibulizumab: a bispecific targeting IL-17A and BAFF
Kulkarni said tibulizumab binds two immune targets: IL-17A and BAFF. He described the two targets as “orthogonal” and suggested the dual mechanism may be suited for complex autoimmune disorders that are not easily categorized as primarily T-cell mediated or B-cell mediated.
He said Zura licensed tibulizumab from Eli Lilly in 2023. According to the company, the bispecific was engineered using sequences from tabalumab (a BAFF-targeting program Lilly advanced into Phase 3) and grafted with complementarity-determining regions (CDRs) from ixekizumab, which Kulkarni noted is approved as Taltz and has been used across multiple indications.
Kulkarni also said Lilly designed tibulizumab to have drug-like properties including low immunogenicity and a naturally long half-life. He added that Lilly tested tibulizumab in 78 subjects across three Phase 1 programs, including healthy volunteers and cohorts in rheumatoid arthritis and Sjögren’s syndrome, providing Zura with data before initiating its Phase 2 trials.
Immunogenicity and dosing approach
Chief Medical Officer Kiran Nistala discussed immunogenicity, noting that in Lilly’s multidose (MAD) study, one participant had a treatment-emergent anti-drug antibody (ADA), which he characterized as under 5% of participants and “low…for bispecifics.” Nistala also said the molecule was designed so both binding arms have high potency with relatively similar affinity, which he said supports equivalent target engagement for BAFF and IL-17.
For Phase 2 dosing, Nistala said the steady-state regimen is once every four weeks (Q4W), with an initial loading period in the first four weeks using three doses (effectively every two weeks). He said dose selection was based on a population pharmacokinetic model and that the top dose of 300 mg Q4W is predicted to provide at least 98% target engagement for both arms.
Hidradenitis suppurativa (HS): Phase 2 data expected in Q4
Zura said the first key readout will come in Q4 of this year from its Phase 2 trial in hidradenitis suppurativa (HS). Kulkarni described HS as a chronic inflammatory dermatologic condition with complex and heterogeneous biology and said current therapeutic responses leave room for improvement.
While IL-17 inhibition has clinical validation in HS, Kulkarni and Nistala emphasized evidence supporting a B-cell/BAFF component. They cited translational observations including B-cells detected in HS lesions and elevated BAFF in affected areas. They also pointed to more recent external clinical data from Novartis’ platform study that included ianalumab (a BAFF pathway modulator), as well as remibrutinib (a BTK inhibitor) and iscalimab (a CD40-targeting agent). Nistala said all three agents targeting the “B-cell axis” showed clinical efficacy in that platform, which he said added comfort to Zura’s approach.
On trial design, the company said it expanded the HS study size to 225 patients. Nistala said Zura selected a dermatology-focused CRO, limited investigators to those with HS experience, and is closely monitoring data quality during the trial. He described use of an independent medical monitor reviewing lesion counts and investigating discrepancies or site outliers to improve signal-to-noise in an endpoint that can be variable.
Regarding enrollment, the company said the HS trial allows up to 30% TNF inhibitor failures, but otherwise focuses on biologic-naïve patients and excludes IL-17 failures, which Nistala said was intended to help clearly identify signal in the first study.
The primary endpoint is reduction in abscess and nodule (AN) count. Kulkarni said there is precedent for using AN count as a continuous primary endpoint and added that the trial is powered for HiSCR 75, assuming a 20%–25% delta versus placebo. He said the company views that range as broadly appropriate for clinically meaningful benefit, while also noting the unmet need in HS and the potential for different clinically meaningful effects even if a single metric falls short of that target. Nistala added that BAFF biology could potentially affect draining tunnels, which may relate to symptoms such as odor and pain, and said the company plans to evaluate patient-reported outcomes.
Systemic sclerosis (SSc): Phase 2 data planned for 1H 2027
Zura’s second Phase 2 program is in systemic sclerosis (SSc), with data expected in the first half of 2027. Kulkarni said the company chose SSc due to high unmet need and the lack of approved therapies for the disease as a whole, describing it as associated with high morbidity and mortality. He said Zura looked for indications with unmet need and at least some validation for both IL-17 and BAFF pathways.
Nistala said the trial focuses on patients with the diffuse subtype, selected for sufficiently severe skin disease to detect signal. He said approximately two-thirds of enrolled patients are expected to have interstitial lung disease (ILD). The primary endpoint is modified Rodnan skin score (mRSS), and the company will also assess sensitive measures of lung inflammation using high-resolution CT (HRCT). Nistala said the study is powered around a three-to-four unit mRSS delta, referencing an MCID of about four units.
The SSc study duration is 24 weeks, which Nistala said is sufficient to observe skin changes. He noted forced vital capacity (FVC) can be slower to change and said the trial is using more sensitive methods, including AI-based quantification of HRCT. Standard of care is allowed; Nistala said mycophenolate mofetil (MMF) is most typical and that patients must be on a stable dose for at least four months to avoid confounding from recent initiation.
Beyond tibulizumab, Kulkarni said Zura has two additional assets—crebankitug (an IL-7 receptor antibody acquired from Pfizer) and torudokimab (an IL-33 program acquired from Lilly)—but emphasized that the company’s primary focus is executing the tibulizumab clinical plan. He said Zura is “ruthless” in capital allocation and indicated the company would provide more color later this year on potential additional indications beyond HS and SSc.
About Zura Bio (NASDAQ:ZURA)
Zura Bio, Inc is a clinical-stage biotechnology company focused on the development of next-generation protein bioconjugates for therapeutic and diagnostic applications. Leveraging a proprietary platform for site-specific incorporation of non-canonical amino acids, the company aims to create highly targeted conjugates that improve drug delivery, enhance imaging contrast, and reduce off-target toxicity. Zura Bio’s technology is designed to streamline the manufacturing process by enabling precise attachment of payloads—such as cytotoxic drugs or imaging agents—to protein scaffolds without affecting their native structure or function.
The company’s research and development activities center on expanding its platform across multiple therapeutic areas, including oncology, immunology and rare diseases.
