SGX945 demonstrates lasting oral ulcer reduction in Phase 2 Behçet’s disease trial

SGX945, an investigational innate defense regulator therapy developed by Soligenix, Inc., has demonstrated durable clinical benefit in a Phase 2 trial for the treatment of Behçet’s disease, according to peer-reviewed results published in Rheumatology (Oxford). The data point to sustained reductions in oral ulcer burden and pain even after treatment cessation, a finding that positions SGX945 as a potential differentiated option in a disease area where patients often face recurrent symptoms and limited long-term therapeutic choices. The publication marks an important validation milestone, as it moves the narrative around SGX945 from company-reported outcomes into an independent scientific forum widely followed by rheumatologists and clinical researchers.

Behçet’s disease is a chronic, multisystem inflammatory disorder characterized by recurrent oral ulcers, genital ulcers, skin lesions, and systemic involvement that can severely impair quality of life. Oral aphthous ulcers affect nearly all patients and are often the most persistent and painful manifestation of the disease. Current treatment strategies rely heavily on symptomatic management and immunomodulatory therapies, many of which require continuous dosing and are associated with tolerability challenges. Against this backdrop, the Phase 2 results for SGX945 highlight both clinical efficacy and durability, two attributes that could meaningfully alter treatment expectations if confirmed in larger trials.

How did the Phase 2 study design evaluate oral ulcer burden and durability of response in Behçet’s disease?

The Phase 2a study was structured as an open-label, proof-of-concept clinical trial evaluating SGX945, also known as dusquetide, in patients with active Behçet’s disease experiencing recurrent oral ulcers. Participants received SGX945 over a four-week treatment period, followed by a post-treatment observation phase extending to week eight. The primary objective was to assess changes in oral ulcer burden, incorporating both the number of ulcers and associated pain, using area under the curve metrics to capture overall disease activity over time.

Seven of the eight enrolled patients experienced clinically meaningful improvement during the treatment period, with reductions observed in both ulcer count and pain severity. Importantly, these improvements were not transient. The published data showed that the therapeutic effect persisted through the follow-up phase, even though dosing ended at week four. This sustained response differentiates SGX945 from therapies that require continuous administration to maintain benefit and suggests a disease-modifying rather than purely symptomatic mechanism of action.

The study also documented resolution of a difficult-to-treat skin ulcer in one participant, adding to the broader clinical signal beyond oral manifestations. Safety outcomes were favorable, with no treatment-related adverse events reported, reinforcing the tolerability profile observed in earlier clinical experience with dusquetide. While the small sample size limits statistical generalization, the consistency of response across participants strengthens the biological plausibility of the findings.

Why does SGX945’s innate defense regulator mechanism matter in inflammatory diseases like Behçet’s disease?

SGX945 belongs to a class of compounds known as innate defense regulators, which are designed to modulate the body’s immune response rather than suppress it outright. Dusquetide works by directing innate immune pathways toward anti-inflammatory signaling, enhanced bacterial clearance, and tissue repair. This mechanism contrasts with traditional immunosuppressive or immunomodulatory therapies that broadly dampen immune activity and can increase susceptibility to infections or produce systemic side effects.

In the context of Behçet’s disease, where dysregulated inflammation drives recurrent tissue damage, an approach that promotes resolution and healing may offer a more balanced therapeutic profile. The durability observed in the Phase 2 trial aligns with this mechanism, suggesting that SGX945 may help reset inflammatory responses rather than merely controlling flare symptoms during active dosing.

This mechanism also helps explain the favorable safety findings. By avoiding broad immune suppression, SGX945 may reduce the risk of adverse events commonly associated with chronic inflammatory disease treatments. The absence of treatment-related side effects in the Phase 2 study, while preliminary, adds weight to the argument that innate defense regulation could represent a viable long-term strategy in Behçet’s disease and potentially other inflammatory indications.

How do SGX945 Phase 2 results compare with existing therapies used for Behçet’s disease oral ulcers?

The Rheumatology (Oxford) publication contextualized SGX945’s results against historical data from a Phase 3 trial of apremilast, the only oral therapy currently approved specifically for Behçet’s disease-related oral ulcers. In that study, apremilast demonstrated a significant reduction in oral ulcer burden compared with placebo after four weeks of continuous treatment. However, the therapeutic effect required ongoing dosing to be maintained.

By comparison, SGX945 achieved similar or greater improvements in area under the curve measures during its four-week treatment phase and maintained a substantial portion of that benefit through week eight, despite the absence of continued dosing. The data indicated an approximate 40 percent improvement relative to placebo benchmarks from the apremilast trial during treatment, with a meaningful level of improvement persisting post-treatment.

This durability may be clinically meaningful for patients who struggle with adherence or experience side effects from long-term therapy. It also raises the possibility of intermittent or finite treatment courses, which could reduce cumulative drug exposure while maintaining disease control. While direct head-to-head trials are needed to draw definitive comparisons, the contextual analysis included in the publication underscores why SGX945 is attracting attention within the clinical research community.

What are the regulatory implications of publication in Rheumatology (Oxford) for SGX945’s development path?

Publication in a high-impact, peer-reviewed journal such as Rheumatology (Oxford) represents more than academic validation. It signals to regulators, clinicians, and potential partners that the underlying data have undergone independent scrutiny and meet the standards expected for advancing clinical development. SGX945 has already received Fast Track and Orphan Drug designations from the United States Food and Drug Administration, reflecting both the unmet medical need in Behçet’s disease and the potential significance of the therapy.

These designations can facilitate more frequent regulatory interactions and, if subsequent trials are successful, may support accelerated review pathways. The Phase 2 publication strengthens Soligenix’s position as it engages with regulators on the design of later-stage trials, including considerations around endpoints, dosing regimens, and patient populations.

The company has indicated that it is exploring reformulation strategies to enable home-based subcutaneous administration, which could further enhance patient convenience and trial feasibility. Such development steps suggest a broader strategic effort to position SGX945 not only as an effective therapy but also as a practical one for real-world use.

How are investors and industry observers interpreting the durability signal from the Phase 2 trial?

From a market perspective, durability of response is increasingly viewed as a key differentiator in inflammatory disease therapeutics. Investors and industry analysts often look beyond short-term efficacy metrics to assess whether a therapy can deliver sustained benefit without escalating safety risks or treatment burden. The Phase 2 SGX945 data, particularly the persistence of effect after dosing stopped, align with this investor narrative.

For Soligenix, which is publicly traded, the publication adds a layer of credibility that may influence sentiment around its pipeline beyond Behçet’s disease. Dusquetide has been evaluated in other inflammatory and infectious contexts, and positive validation in one indication can have spillover effects on how the broader platform is perceived. While stock performance ultimately depends on multiple factors, including capital needs and broader market conditions, peer-reviewed clinical validation is typically viewed as a constructive signal.

Industry observers also note that Behçet’s disease remains a niche indication with limited competition, increasing the strategic value of differentiated assets. If SGX945 advances successfully into Phase 3 trials, it could attract partnership interest from larger pharmaceutical companies seeking to expand their immunology portfolios.

What could SGX945’s Phase 2 findings mean for patients living with Behçet’s disease?

For patients, the most compelling aspect of the Phase 2 results is the potential for lasting relief from one of the most painful and disruptive symptoms of Behçet’s disease. Recurrent oral ulcers can interfere with eating, speaking, and daily functioning, often leading to cumulative physical and emotional burden. A therapy that reduces both frequency and pain, while continuing to work after treatment ends, could represent a meaningful improvement in disease management.

While it is important to emphasize that Phase 2 results are preliminary and require confirmation in larger, controlled studies,, the published data offer a cautiously optimistic signal. They suggest that SGX945 may not only control symptoms but also influence the underlying inflammatory processes that drive recurrence. For a patient population with few tailored options, such advances carry significant clinical relevance.

As Soligenix moves forward with its development plans, the transition from promising Phase 2 data to definitive Phase 3 outcomes will be closely watched by clinicians, patients, and investors alike. The publication in Rheumatology (Oxford) ensures that SGX945’s journey will continue under the spotlight of the broader scientific and medical community.