Chronic Rare Diseases in an Aging America: Why HyBryte and Federal Policy Matter Now

BioMedWire Editorial Coverage: Chronic conditions and rare diseases in the aging population present an urgent and expanding challenge within the U.S. healthcare system, especially as more than 30 million Americans are affected by rare diseases, according to the National Institutes of Health. The vast majority of these conditions lack any FDA-approved treatment, leaving older adults especially vulnerable as age-related symptoms often obscure or delay diagnosis. This rising burden has increased demand for new therapies that can address real unmet need. Soligenix Inc. (NASDAQ: SNGX) (Profile), a late-stage biopharmaceutical company, is developing multiple treatments for rare diseases, including HyBryte[TM] (synthetic hypericin) for cutaneous T-cell lymphoma, and is now conducting the final confirmatory clinical study required before filing for worldwide marketing approval. As the Trump administration advances new health policy initiatives affecting chronic and rare diseases, Soligenix’s work sits at a critical intersection of medical innovation and national health priorities. The company is working alongside several leading companies committed to making an impact in the pharmaceutical and life sciences space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM).

• Cutaneous T-cell lymphoma (“CTCL”) is a rare subtype of non-Hodgkin’s lymphoma that disproportionately affects older adults.
• SNGX’s confirmatory FLASH2 study represents the final major step toward potential worldwide marketing approval for HyBryte.
• The first FLASH phase 3 trial demonstrated statistically significant efficacy, establishing a strong foundation for the confirmatory FLASH2 study.
• An ongoing investigator-initiated study at the University of Pennsylvania is providing additional real-world insight into HyBryte’s effectiveness.
• Beyond its immediate CTCL application, HyBryte’s life-cycle management strategy includes opportunities to expand the treatment’s reach and value.

A Diagnostic Challenge Meets Policy Change

Rare diseases have long been difficult to diagnose, but older adults often face a uniquely complex path. Many rare disease symptoms overlap with common age-related conditions such as dermatologic changes, cognitive decline, chronic inflammation or fatigue, making misdiagnosis a persistent problem. According to the National Organization for Rare Disorders (“NORD”), patients often go five to seven years before receiving an accurate diagnosis. This diagnostic delay can worsen outcomes, delay treatment, and create emotional and financial stress, particularly for older adults who frequently see multiple specialists without definitive answers.

Symptoms of rare diseases can also mimic those associated with normal aging. For example, skin changes that may appear benign can mask early manifestations of CTCL. Neurological or systemic symptoms related to rare autoimmune or genetic disorders may be mistaken for more common issues such as arthritis or dementia. This overlap complicates clinical assessments and often forces physicians to rely on advanced testing or second opinions to reach a conclusive diagnosis.

 

For more information about Soligenix Inc., visit the Soligenix Profile.

 

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