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NEW YORK , Aug. 4, 2025 /PRNewswire/ -- As America's population ages, chronic and rare diseases are emerging as a pressing healthcare challenge — one that disproportionately affects older adults. With more than 30 million Americans living with a rare disease, the need for accurate diagnoses and effective treatments is growing urgent. Many of these conditions remain without FDA-approved therapies, and symptoms in seniors are often misattributed to typical aging, leading to years-long diagnostic delays. Recognizing this crisis, the Trump administration's "Make America Healthy Again" initiatives have emphasized improving access to treatments and accelerating medical innovation. Advancing this mission, Soligenix Inc. (NASDAQ: SNGX) (Profile) is making strides with its HyBryte(TM) platform, a novel therapy aimed at treating cutaneous T-cell lymphoma (CTCL), a rare skin cancer that primarily affects older adults. With successful U.S.-based manufacturing of HyBryte's active ingredient now in place, Soligenix exemplifies the kind of domestic innovation poised to make a meaningful impact on this underserved patient population. The company is one of several impressive companies committed to making an impact in the pharmaceutical space, including Pfizer Inc. (NYSE: PFE), Merck & Co Inc. (NYSE: MRK), Bristol-Myers Squibb Co. (NYSE: BMY) and Insmed Inc. (NASDAQ: INSM).

• Soligenix Inc.'s HyBryte platform represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults.
• A second confirmatory phase 3 clinical trial for HyBryte is underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL.
• HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses.
• A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies.

Click here to view the custom infographic of the Soligenix Inc. editorial.

Chronic rare diseases are emerging as a major challenge within the aging U.S. population. As life expectancy increases, so too does the complexity of healthcare needs, particularly when it comes to conditions that are both long-lasting and difficult to diagnose. Tens of millions of Americans are facing life with a rare disease, and many of them are seniors whose symptoms can easily be dismissed as normal signs of aging.

Because rare diseases often present subtly or mimic more common age-related issues, diagnosis in older adults can be delayed by years, hindering access to effective care and worsening outcomes. Compounding the issue is the limited availability of FDA-approved treatments. With thousands of rare diseases identified, the vast majority remain without approved therapies, underscoring the importance of continued investment in research and development. Seniors, in particular, are vulnerable to underdiagnosis and undertreatment, especially when the healthcare system is not attuned to the nuanced presentation of rare conditions in older adults.

In response, the "Make America Healthy Again" initiative has spotlighted the growing burden of chronic and rare diseases. Through targeted policies aimed at accelerating research, improving diagnostic tools and expanding access to care, these efforts seek to address the needs of older Americans grappling with complex, often overlooked, health challenges.

Companies such as Soligenix Inc. are rising to meet this need. The firm's HyBryte program represents a promising therapeutic option for cutaneous T-cell lymphoma, a rare cancer that often affects older adults. Soligenix has recently completed the successful U.S. manufacturing transfer of HyBryte's active ingredient, advancing its mission to bring effective, innovative treatments to patients most in need.

Cutaneous T-cell lymphoma (CTCL) is a rare form of non-Hodgkin's lymphoma (NHL) that primarily affects the skin. Unlike other lymphomas, CTCL involves malignant T-cells that migrate to the skin's surface, forming patches, lesions or tumors. This chronic cancer most commonly appears in older adults, making it particularly relevant to the aging population. Despite its rarity, CTCL remains a serious medical concern, affecting more than 40,000 NHL patients globally.

There is currently no known cure for CTCL, and treatment is often limited to managing symptoms and slowing disease progression. The most prevalent subtype of CTCL is mycosis fungoides (MF), which accounts for approximately 90% of all CTCL cases. In its early stages (I–IIA), MF has a relatively high five-year survival rate of 88%, but it remains a lifelong illness. As a chronic condition with no approved first-line therapy for early-stage patients, CTCL represents a clear unmet medical need.

The global market opportunity for CTCL therapies in the seven major markets (the United States, EU4, the United Kingdom and Japan) was estimated at about $995 million in 2024, with the U.S. accounting for some 70% of that. In addition, DelveInsight notes that "the expected launch of therapies such as HyBryte . . . will also boost the CTCL market growth." Without these new therapies, effective treatment options remain limited, especially for those diagnosed in the early stages. Many patients undergo a series of therapies with limited success, underscoring the need for innovative, targeted treatments.

Soligenix's HyBryte (synthetic hypericin) offers a promising solution as a potential first-line therapy for early-stage CTCL. By addressing this critical gap in care, HyBryte has the potential to significantly improve quality of life for thousands of patients and become a leading treatment option in this underserved market.

Soligenix's second confirmatory phase 3 clinical trial for HyBryte, known as FLASH2, is currently underway and represents a pivotal step in advancing the therapy toward global commercialization for the treatment of early-stage CTCL. Designed to reinforce the positive findings of the initial FLASH study, FLASH2 has been accepted by the European Medicines Agency (EMA), while discussions with the U.S. Food and Drug Administration (FDA) remain ongoing.

This validation by European regulators underscores the robustness of the trial design and its alignment with international standards for therapeutic approval. The FLASH2 study maintains a similar structure to its predecessor but features an extended double-blind, placebo-controlled treatment duration of 18 weeks, three times longer than the original six-week period in the first FLASH trial. This longer timeline is expected to provide even more comprehensive data on HyBryte's safety and efficacy. Importantly, key elements such as the patient inclusion and exclusion criteria and the primary endpoint remain consistent between the two studies, supporting the integrity and comparability of the trial outcomes.

Approximately 80 patients will be enrolled across clinical sites in both the United States and Europe. This multinational approach is intended to support broad regulatory submissions and pave the way for HyBryte's commercial launch on a global scale. With enrollment progressing on schedule, Soligenix anticipates reporting top-line results in 2026, data that could significantly bolster the case for HyBryte as the first approved front-line treatment for early-stage CTCL.

As Soligenix continues to advance this promising therapy, FLASH2 stands as a potentially transformational milestone in the company's effort to address a long-standing unmet medical need within the rare disease and oncology communities.

Soligenix's HyBryte achieved positive, statistically significant results in its first phase 3 clinical trial, known as the FLASH study, marking a critical advancement in the treatment of early-stage CTCL. HyBryte received both U.S. and EU orphan drug designations as well as Fast Track status from the FDA, underscoring the serious unmet medical need it addresses.

Unlike many CTCL therapies that require a year or more to demonstrate efficacy, HyBryte showed a statistically significant treatment response in just six weeks, with response rates improving to 40% at 12 weeks and 49% at 18 weeks. The therapy demonstrated effectiveness across both patch and deeper plaque lesions, an important distinction given that many current early-stage CTCL treatments are primarily effective only on patch-type manifestations. This broader lesion response highlights HyBryte's unique therapeutic potential within a complex and varied disease presentation. The study's design and outcomes also reflect the treatment's clinical promise as a practical, noninvasive solution that could change the standard of care for CTCL patients.

Safety and tolerability further set HyBryte apart. The FLASH trial reported minimal adverse events, a significant benefit when compared to other CTCL therapies that are often associated with both acute and chronic side effects. This favorable safety profile may make HyBryte especially appealing to older patients who are frequently managing multiple health conditions.

Additionally, HyBryte's use of visible fluorescent light rather than ultraviolet (UV) light avoids the carcinogenic risks typically associated with conventional phototherapy. This novel light-based activation of synthetic hypericin enhances patient safety while maintaining therapeutic efficacy. Collectively, the FLASH and FLASH2 study results position HyBryte as a strong candidate to become the first approved front-line treatment for early-stage CTCL, offering a faster, safer, and more effective alternative to existing therapies.

A critical attribute of HyBryte in the treatment of CTCL is its consistently strong safety profile, demonstrated across multiple clinical studies. Unlike many current therapies for early-stage CTCL, which are typically associated with severe and sometimes fatal side effects, HyBryte has been well tolerated and shows no evidence of safety concerns to date. Its mechanism of action is not linked to DNA damage, a significant distinction that positions it as a potentially safer alternative in a treatment landscape where many options carry risks such as melanoma, other malignancies, severe skin damage and premature skin aging.

This favorable safety profile is especially relevant given that all currently available CTCL therapies are only approved following the failure of other treatments, and none have been approved for front-line use. In this context, safety becomes a decisive factor in selecting a treatment course, particularly for older adults who are often managing multiple health conditions. HyBryte's minimal systemic absorption, non-mutagenic compound and use of a non-carcinogenic visible light source make it uniquely positioned as a safe and effective treatment option. As the CTCL community awaits a first-line therapy, HyBryte stands out as a promising candidate capable of meeting both efficacy and safety demands.

In addition to its strong clinical profile, HyBryte represents a significant commercial opportunity in an area of high unmet medical need. With an estimated global CTCL market potential exceeding $990 million, the therapy is well positioned to address a meaningful segment of the CTCL population. As development advances, HyBryte offers the potential not only to improve patient outcomes but also to establish itself as a valuable new standard in CTCL treatment.

In an era where precision medicine and urgent unmet needs converge, several pharmaceutical leaders are stepping up with bold new advances in cancer and complex disease treatment, from improving survival outcomes in prostate and lung cancer to advancing novel therapies for pulmonary hypertension. These developments reflect a broader commitment across the life sciences industry to accelerate innovation and deliver life-extending, quality-of-life-enhancing options for patients with high-need conditions.

Pfizer Inc.  is reporting positive topline results from the overall survival (OS) analysis from its phase 3 EMBARK study. The study evaluated XTANDI(R) (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) with biochemical recurrence (BCR) at high risk for metastasis. The announcement was made with Astellas Pharma U.S. Inc. XTANDI is the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in nmHSPC with high-risk biochemical recurrence BCR.

Merck & Co Inc. announced that the first patient has been dosed in the IDeate-Prostate01 phase 3 trial. The phase 3 study evaluates the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor. I-DXd is being jointly developed by Merck and Daiichi Sankyo. While localized prostate cancer has a five-year survival rate of more than 90%, survival decreases to 31% in the advanced or metastatic stage, the company noted, reinforcing the need for new approaches to improve outcomes.

Bristol-Myers Squibb Co.  has received critical approval from the European Commission (EC) for a key perioperative regimen. The regimen is for neoadjuvant Opdivo(R) (nivolumab) and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%. The EU approval is based on results from the CheckMate-77T trial, which showed perioperative Opdivo improved event-free survival compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.

Insmed Inc. announced positive topline results from its randomized, double-blind, placebo-controlled phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH). According to the announcement, the study met primary and all secondary efficacy endpoints. Insmed noted that it plans to immediately engage with the U.S. Food and Drug Administration regarding a phase 3 trial design for PAH. Insmed plans to initiate a phase 3 trial in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) before the end of 2025 and a phase 3 trial in patients with PAH in early 2026.

These announcements spotlight the momentum building across rare-disease research, with these companies contributing key pieces to the larger puzzle of patient-centered medical breakthroughs. As regulatory engagement continues and phase 3 trials advance, the coming years may bring meaningful shifts in standard-of-care therapies, offering hope to patients facing some of the most challenging diagnoses in medicine today.

For more information, visit Soligenix Inc.

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