AUSTIN, Texas, Dec. 04, 2025 (GLOBE NEWSWIRE) -- BioMedWire Editorial Coverage: Chronic illnesses and rare disorders among older Americans represent a rapidly intensifying challenge for the U.S. healthcare system, with the National Institutes of Health estimating that more than 30 million people nationwide are living with a rare disease. Most of these conditions have no FDA-approved therapies, leaving older adults particularly at risk as age-related changes can mask or delay accurate diagnosis. This growing strain on care has heightened the need for novel treatments that address significant unmet medical needs. Soligenix Inc. (NASDAQ: SNGX) (Profile), a late-stage biopharmaceutical developer, is advancing several rare-disease therapies, including HyBryte[TM] (synthetic hypericin) for cutaneous T-cell lymphoma (CTCL), where it is currently running the final confirmatory trial necessary before seeking global marketing authorization. As the Trump administration pursues new health-policy measures focused on chronic and rare diseases, Soligenix’s programs are positioned at a pivotal crossroads of scientific innovation and national healthcare goals. The company is working alongside several prominent leaders in the pharmaceutical and life sciences sectors, including AMGEN Inc. (NASDAQ: AMGN), Amicus Therapeutics Inc. (NASDAQ: FOLD), Citius Oncology Inc. (NASDAQ: CTOR) and Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP).

• CTCL, a rare form of non-Hodgkin’s lymphoma, disproportionately affects older individuals.
• FLASH2 represents the final major confirmatory step before Soligenix can pursue worldwide marketing approvals for HyBryte.
• The initial FLASH trial delivered statistically significant results and set the stage for the FLASH2 confirmatory program.
• A continuing investigator-initiated study at the University of Pennsylvania is offering additional insight into HyBryte’s real-world performance.
• Beyond its established CTCL indication, Soligenix is pursuing several life-cycle opportunities to expand HyBryte’s reach and value.
  
  

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A Complex Diagnostic Puzzle Amid Shifting Federal Priorities

Rare diseases have historically been hard to diagnose, but older adults often encounter even greater hurdles. Many symptoms associated with rare conditions resemble common age-related issues, such as rashes, cognitive changes, chronic inflammation or persistent fatigue, creating ongoing risk for misdiagnosis. The National Organization for Rare Disorders (NORD) reports that patients typically endure a five- to seven-year journey before clinicians reach an accurate diagnosis.

Such delays can worsen outcomes, postpone interventions and create emotional and financial strain, especially for seniors who may cycle through several specialists before receiving clarity. Symptoms linked to rare disorders can also be mistaken for normal aging. For instance, minor-appearing skin abnormalities can disguise early cutaneous T-cell lymphoma (CTCL). Neurological or systemic manifestations tied to rare autoimmune or genetic conditions may be misinterpreted as dementia, arthritis, or other routine geriatric concerns. This overlap complicates clinical evaluations and often necessitates advanced diagnostics or additional expert opinions to determine the correct diagnosis.

Meanwhile, federal policy is evolving to address widespread chronic disease pressures. The Trump administration’s Make America Healthy Again initiative underscores early screening, chronic-care management and broadened access to innovative therapies. The program also cites goals related to affordability, better care coordination and faster approval pathways for next-generation treatments.

Soligenix is focused on several initiatives that fit within these national healthcare objectives. The company recently shifted U.S.-based manufacturing of HyBryte’s active pharmaceutical ingredient, strengthening domestic supply chains. Soligenix is also conducting FLASH2, the confirmatory phase 3 replication trial of HyBryte for CTCL. This study builds on the prior statistically significant FLASH trial, a successful comparative study, and multiple investigator-initiated projects, together forming a comprehensive dataset that informs FLASH2 expectations.

A Rising Challenge for an Aging Population

CTCL, a rare form of non-Hodgkin’s lymphoma, disproportionately affects older individuals. The disease occurs when malignant T-cells migrate to the skin, creating patches, plaques or tumors that intensify or expand over time. CTCL is chronic, non-curable and frequently misdiagnosed early on because it mimics eczema, psoriasis and other common dermatologic conditions seen in older adults.

Epidemiological estimates indicate that more than 70,000 non-Hodgkin’s lymphoma patients worldwide are affected by CTCL. The global CTCL treatment market is valued at over $250 million, with approximately $90 million attributed to the U.S. Despite this market, therapeutic choices remain scarce. No approved first-line option exists for early-stage CTCL (stage I–IIA), which represents nearly 90% of cases. Most patients depend on off-label medications, phototherapy or immune-modulating approaches, many of which involve significant risks or inconsistent long-term results.

Mycosis fungoides, the most prevalent CTCL subtype, accounts for the majority of cases. Although early-stage disease has a five-year survival rate of roughly 88%, it is a chronic cancer with unpredictable progression. Many existing therapies require lengthy timelines—often a year or more—before yielding statistically meaningful improvement.

HyBryte introduces a new mechanism specifically tailored for early-stage CTCL and is positioned to fill this critical treatment gap. If approved, it could become the first front-line option for early disease, using a photodynamic approach in which synthetic hypericin is activated by visible light. Its targeted mode of action, demonstrated efficacy, and potential safety benefits set it apart from ultraviolet phototherapy and systemic agents.

Driving Toward Global Regulatory Milestones

FLASH2 represents the final major confirmatory step before Soligenix can pursue worldwide marketing approvals for HyBryte. The European Medicines Agency has already accepted the trial design, which mirrors the original FLASH study and includes an extended 18-week double-blind, placebo-controlled treatment period. This modification reflects regulator feedback as well as findings from comparative trials and academic studies supporting longer treatment durations.

The FLASH2 study is expected to enroll about 80 patients, adhering to international regulatory criteria. Enrollment and exclusion criteria remain aligned with the first FLASH study, preserving consistency and enabling direct comparison. Enrollment is progressing on target, with approximately 50 patients enrolled as of November 18. Interim data are anticipated in the second quarter of 2026, followed by top-line results later in 2026.

FLASH2 carries considerable importance because the initial phase 3 trial generated clear and statistically significant efficacy and safety outcomes. Those results, combined with orphan designations in both the U.S. and EU and FDA fast-track status, position HyBryte as one of the most advanced CTCL therapies in late-stage development.

Regulatory discussions with the FDA are ongoing, and FLASH2 is intended to fulfill the final requirements for a global submission package. Should the trial replicate or improve upon the original FLASH results, Soligenix will be positioned to file for marketing authorization across multiple regions. Late-stage programs with validated endpoints—particularly those addressing conditions lacking a first-line therapy—are highly valued in the rare-disease sector, and HyBryte fits this profile.

Given CTCL’s chronic nature and absence of curative treatments, regulators have generally supported therapies demonstrating strong safety profiles, durability and quality-of-life benefits. HyBryte aligns with these priorities by offering a targeted, localized treatment with minimal systemic exposure. If FLASH2 succeeds, HyBryte could become a cornerstone CTCL therapy worldwide.

Robust Phase 3 Findings, Key Clinical Advantages

The initial FLASH trial delivered statistically significant results and set the stage for the FLASH2 confirmatory program. HyBryte generated measurable responses within six weeks, with improvements increasing over time, ultimately reaching 40% at week 12 and 49% at week 18. These timelines contrast with many current CTCL therapies, which can take a year or more to demonstrate meaningful benefits.

HyBryte has shown effectiveness against both patch and plaque lesions. This is especially notable because several early-stage CTCL treatments primarily target patches, leaving thicker plaques less responsive. Plaques are considered potential markers of disease progression, so HyBryte’s broader activity addresses a known therapeutic gap and may benefit a wider range of CTCL patients.

One of HyBryte’s strongest characteristics is its safety profile. Across multiple studies, HyBryte has been well tolerated with limited adverse effects. Unlike UV-based phototherapy—which can increase melanoma risk, accelerate skin aging, or trigger additional skin cancers—HyBryte uses visible light and a nonmutagenic compound. No evidence of DNA damage, systemic toxicity or cumulative carcinogenic risk has been observed.

Current CTCL treatments frequently pose serious risks, including immune suppression, secondary cancers or significant skin toxicity. Because CTCL requires lifelong management, safety is a central consideration. HyBryte’s favorable profile positions it as a potentially transformative therapy that delivers improvement without undermining long-term safety.

Commercial expectations reflect these clinical strengths. With a market exceeding $250 million worldwide, HyBryte may help meet an unmet need in a therapeutic landscape that has seen little innovation. If FLASH2 confirms earlier findings, HyBryte could emerge as the first front-line option with international reach.

Investigator Study Demonstrates Promising Response Rate

A continuing investigator-initiated study at the University of Pennsylvania is offering additional insight into HyBryte’s real-world performance. The study administers HyBryte twice weekly for up to a year, allowing researchers to assess long-term durability and extended dosing. At 18 weeks, the primary endpoint window used in FLASH2, the study has reported a 75% response rate.

These results are significant for two reasons. First, they confirm the rationale for FLASH2’s extended dosing period. Second, they provide independent academic validation, showing that HyBryte’s efficacy is reproducible outside the controlled environment of a phase 3 trial.

Investigator-initiated studies are often essential in rare dermatologic diseases because they help clinicians understand how therapies perform across diverse patient presentations. HyBryte’s strong academic results reinforce its potential as a first-line option for early-stage CTCL, especially given the chronic nature of the disease.

As more data emerge, physicians gain greater confidence in adopting new therapies. The University of Pennsylvania’s findings also indicate potential long-term benefit with extended treatment, an important factor for chronic CTCL management. Because CTCL requires lifelong monitoring and periodic interventions, therapies that sustain efficacy without adding long-term toxicity are ideal. HyBryte’s performance in academic settings supports this need and strengthens the case for its use after regulatory approval.

Strategic Outlook, Long-Term Potential

Beyond its established CTCL indication, Soligenix is pursuing several life-cycle opportunities to expand HyBryte’s reach and value. A key initiative involves potential at-home dosing using portable light devices, allowing qualified patients to self-administer treatment. This model could significantly widen access, reduce clinical burden and improve convenience, particularly for older adults who may face transportation or mobility challenges.

HyBryte’s photoactivated mechanism may also have applications in other dermatologic conditions. Soligenix is evaluating synthetic hypericin for use in mild-to-moderate psoriasis and other chronic inflammatory skin diseases. Photodynamic therapies are common in dermatology, and HyBryte’s safety characteristics make it a strong candidate for broader clinical use.

Tomas J. Philipson, PhD, a former acting chair of the White House Council of Economic Advisers and senior advisor in the Trump administration, continues to advise Soligenix on regulatory and commercial strategy. His background in healthcare economics and policy is expected to support Soligenix’s efforts as it advances HyBryte toward approval.

HyBryte’s clinical program is substantially de-risked compared with most late-stage candidates. It has already demonstrated statistically significant results in a prior phase 3 trial, replicated effects in a comparative study, delivered strong outcomes in an investigator-initiated trial, and generated extensive safety data across multiple investigations. FLASH2 represents the last major clinical step before global filings, with top-line results expected in late 2026.

As important milestones approach over the next year, Soligenix is entering a transformational period. A positive FLASH2 readout could substantially increase the therapy’s value by positioning HyBryte as the first-line treatment for early-stage CTCL—a field with longstanding unmet need and meaningful commercial potential. At a time when national policy is increasingly focused on chronic and rare diseases in the aging population, HyBryte stands out as a significant potential advance in dermatologic oncology.

Key Advances Reshape Expanding Biopharma Landscape

Breakthroughs across the biopharma sector continue to redefine what is possible in modern medicine. Recent regulatory approvals, new therapeutic launches and expanded access to innovative treatments underscore the industry’s momentum as it pushes forward with therapies designed to address complex and often underserved conditions.

AMGEN Inc. (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (“FDA”) has granted full approval to IMDELLTRA[R] (tarlatamab-dlle). The approval is for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Additionally, the National Comprehensive Cancer Network(R) Clinical Practice Guidelines in Oncology were recently updated to include tarlatamab as the only category 1 preferred treatment option for adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy.

Amicus Therapeutics Inc. (NASDAQ: FOLD) reported that Japan's Ministry of Health, Labour and Welfare has approved Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for the treatment of adult patients with late-onset Pompe disease. The company noted that the approval provides a compelling new treatment option to patients living with late-onset Pompe disease in Japan. Pombiliti + Opfolda is a two-component therapy: Pombiliti is a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), designed for increased uptake into muscle cells, while Opfolda is an enzyme stabilizer designed to stabilize the enzyme in the blood.

Citius Oncology Inc. (NASDAQ: CTOR) has launched LYMPHIR[TM] (denileukin diftitox-cxdl), a novel IL-2 receptor-directed fusion protein. LYMPHIR is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of adult patients with relapsed or refractory stage 1–3 CTCL after at least one prior systemic therapy. The company noted that “with a median time to response of 1.4 months in the phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease.”

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) announced that TONMYA[TM (cyclobenzaprine HCl sublingual tablets) is now commercially available by prescription in the United States. TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime. The company called the availability of TONMYA “a momentous day for Tonix,” noting that the drug provides the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease: widespread pain.

As biopharma leaders advance novel therapies and broaden treatment choices, patients stand to benefit from a stronger and more diverse therapeutic ecosystem. The latest milestones highlight an industry accelerating toward more effective, targeted and patient-centric solutions. With continued research, regulatory progress and scientific collaboration, the path ahead promises even greater innovation and expanded opportunities to transform outcomes in critical disease areas.

For more information, visit the Soligenix Profile.

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