- This milestone is significant because regulatory pathways for orphan diseases such as CTCL often hinge not only on efficacy, but on establishing a favorable safety profile.
- Soligenix’s announcement arrives amid mounting interest in HyBryte[TM] as a novel skin-directed therapy.
- For biotechnology companies working in rare diseases, reaching a safety milestone means one major hurdle is cleared and focus can shift more explicitly to efficacy and regulatory strategy.
In a key development that underscores the advancing clinical trajectory of its lead therapy, Soligenix (NASDAQ: SNGX) announced that the Data Monitoring Committee (“DMC”) overseeing its confirmatory Phase 3 FLASH2 trial of HyBryte(TM) has reported no safety concerns to date, affirming the therapy’s safety profile. Soligenix, a biopharmaceutical company focused on rare diseases and treatments with substantial unmet need, is developing HyBryte (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (“CTCL”) and is now advancing toward critical milestones in 2026.
According to the company, the DMC concluded that there are no safety issues with the ongoing Phase 3 trial (https://ibn.fm/NGMxi). The study, named FLASH2, builds on the earlier Phase 3 FLASH trial and will enroll approximately 80 subjects with early-stage CTCL, patch or plaque phase disease (https://ibn.fm/VNG61). With the safety signal confirmed, the company plans to provide an enrollment update in the fourth quarter of 2025 and aims for a blinded interim efficacy analysis in the first half of 2026.
This milestone is significant because regulatory pathways for orphan diseases such as CTCL often hinge not only on efficacy, but on establishing a favorable safety profile. The absence of safety concerns at this stage may de-risk the program from an investor or licensing perspective.
Soligenix’s announcement arrives amid mounting interest in HyBryte as a novel skin-directed therapy. The product uses synthetic hypericin activated by visible light to treat lesions in CTCL patients. According to the company, its earlier Phase 3 FLASH trial enrolled some 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL and demonstrated a 49% response rate after 18 weeks (p < 0.0001 versus placebo) in patients completing therapy (https://ibn.fm/zpXC9). Additional data from an investigator-initiated study reported 75% of evaluable patients achieving at least a 50 % reduction in lesion severity score (“mCAILS”) at 18 weeks (https://ibn.fm/KGzxt). These results highlight both the potential activity and tolerability of the therapy.
The ongoing FLASH2 study is designed as a randomized, double-blind, placebo-controlled trial in approximately 80 patients, testing 18 continuous weeks of treatment with HyBryte versus placebo, with the primary endpoint to be assessed following that 18-week period. This extended continuous treatment period, versus the previous three-cycle design, is intended to reflect a more “real-world” therapy course and may provide a more robust demonstration of benefit.
For biotechnology companies working in rare diseases, reaching a safety milestone means one major hurdle is cleared and focus can shift more explicitly to efficacy and regulatory strategy. Soligenix’s ability to report no safety concerns builds confidence among investors, partners and regulators. According to Zacks Small-Cap Research, the company confirmed the safety milestone and is now preparing for an interim efficacy readout while enrollment continues to track with expectations. With this in hand, licensing conversations, potential partnerships and investor sentiment may accelerate.
Beyond safety, the broader program context is compelling. CTCL is a rare, chronically debilitating skin lymphoma for which treatment options remain limited, especially in early stage disease. HyBryte’s mode of action, topical application of synthetic hypericin followed by visible light activation, offers a skin-directed, potentially safer alternative to systemic therapies or more invasive treatments (https://ibn.fm/viIvg). The company emphasizes the therapy can treat both patch and plaque lesions, has a relatively benign side-effect profile and could potentially be adapted for home or office use. Supporting data show only 2.4% of treated patients in the prior trial experienced serious adverse events, and most adverse events were mild skin-related issues such as pruritus or erythema.
With the DMC safety declaration achieved, Soligenix is well positioned to shift toward its upcoming milestones: completion of enrollment, announcement of the interim efficacy readout in the first half of 2026, and eventual regulatory submissions in the United States and Europe if results are positive. The company’s pipeline and strategy align well with an orphan disease framework, supported by prior data, regulatory incentives (including Orphan Drug designation), and a therapy approach that addresses a clear unmet medical need.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
