Soligenix's Leadership Aims To Drive Growth In Rare Disease Markets In 2025 And 2026

Soligenix SNGX achieved several important milestones last year as it attempted to address unmet needs in oncology and inflammation. Entering 2025, the firm says it is hoping to continue building on that momentum. 

Soligenix has a dual market focus: specialized biotherapeutics and public health solutions. The company's specialized biotherapeutics division is dedicated to developing products for orphan diseases and areas of unmet medical need, such as cutaneous T-cell lymphoma, psoriasis, oral mucositis, Behçet's disease and pediatric Crohn's disease. This segment is where much of the firm's product initiatives reside.

On the other hand, its public health solutions division seeks to develop heat stable vaccines and therapeutics for military and civilian applications in the areas of ricin exposure and viral disease including Ebola, Marburg and COVID-19. This division of the company has received in excess of $60 million of non-dilutive government funding to date, Soligenix reports.

2024 Milestones: Comparative Study Highlights HyBryte's Safety 

In early 2025, Soligenix announced that their lead product, HyBryte^TM (synthetic hypericin), a potential treatment for cutaneous T-cell lymphoma (CTCL), a rare, chronic and incurable type of non-Hodgkin lymphoma affecting the skin, was demonstrating strong responses in a "real-life" treatment study conducted by Dr. Ellen Kim at the University of Pennsylvania and supported by an approximate $2.6 million FDA orphan grant. This result built on an earlier update from this same study in 2024, which the company said also demonstrated that 18 weeks of treatment yielded robust treatment responses. 

In a separate comparability study, Soligenix announced in December last year that HyBryte^TM also demonstrated continued improvement in treated patients and their lesions, even after stopping treatment. This exploratory study compared the efficacy of HyBryte™ to Valchlor^® (mechlorethamine). 

These studies both built on previous statistically significant results from the company's first phase 3 placebo-controlled study (referred to as the FLASH study), and further support the recently initiated confirmatory phase 3 placebo-controlled replication study (referred to as FLASH2). 

Dr. Brian Poligone, director of the Rochester Skin Lymphoma Medical Group, and principal investigator for the comparability study said they found that, "despite the small study sample size and a randomization that resulted in the HyBryte™ group having patients with more extensive disease, HyBryte™ continues to demonstrate its rapid onset of action and benign safety profile, compared to Valchlor^®, one of the most widely prescribed approved drugs for early-stage CTCL. We look forward to continuing our support of Soligenix in the development of HyBryte™ by participating in the upcoming confirmatory phase 3 placebo-controlled study." 

Also, regarding HyBryte™, in October 2024, Soligenix announced that the Hong Kong Patent Office had granted the patent entitled “Systems and Methods for Producing Synthetic Hypericin.” Synthetic hypericin is the active ingredient in HyBryte™. Soligenix also received a similar patent in Europe.

The company reports that it is also developing a treatment for oral mucositis. Mucositis is damage to the lining of the mouth and gut due to cancer treatment. Severe oral mucositis (SOM) occurs when the damage is so severe that a patient's ability to eat and drink is compromised, adversely affecting their digestive and immune systems. Soligenix's SGX942 is an intravenous (IV) formulation of the Innate Defense Regulator (IDR), dusquetide, for treating SOM, and Soligenix managed to get fast-track designation for the treatment in the U.S. 

Dusquetide is also the active ingredient in Soligenix's SGX945 for the treatment of Behçet’s disease. It is a chronic and incurable autoimmune condition caused by blood vessel inflammation. In 2024, Soligenix announced the phase 2 clinical trial of SGX945. The clinical trial is an open-label study that will involve around 25 adult patients with Behçet’s Disease and active oral and/or genital ulcers. Patients will receive SGX945 as a twice-weekly four-minute IV infusion for four weeks, followed by four weeks of follow-up. Dusquetide has received fast-track designation in this disease as well in the U.S.

Regarding their public health solutions, Soligenix's RiVax^® is a thermostable safe alum-adjuvanted subunit vaccine candidate that may prevent death and injury from exposure to ricin toxin, a lethal yet easily manufactured white powder that can induce irreversible symptoms within four hours of exposure, and may cause death within 48 to 72 hours, the company reports.

With the rise in antibiotic-resistant bacteria, Soligenix's SGX943 is an investigational, IV formulation of the IDR, dusquetide, for treating antibiotic-resistant bacteria and infectious diseases. SGX943 contains the same active ingredient as in both SGX942 and SGX945; it is a rapid four-minute injection that may be administered upon suspicion of bacterial-origin infection before any confirmatory testing and may be given in combination with antibiotics.

Driven By Market Potential, Strong Management Team

As noted in their January 2025 corporate presentation, the total addressable markets (TAM) Soligenix is operating in are significant. Mild-to-moderate psoriasis has a TAM of over a billion with some 3 million patients in the U.S. alone, the company reports, while oral mucositis in head and neck cancer has an estimated size of half a billion.

In the public health realm, the commercialization of Soligenix’s public health offerings could open them up to clients such as the U.S. government and other economies, where they could supply vaccines via government procurement contracts. Alternatively, given Soligenix's focus on treating rare diseases, the priority review vouchers (PRV) awarded to them by the FDA can be sold. Their recent presentation deck noted that up to three PRVs have sold for approximately $100 million.

Soligenix is fortunate to have various industry leaders at the helm, with much of the executive leadership team having decades of experience in the pharmaceutical industry or their specialized areas. Christopher J. Schaber, PhD, chairperson, president and CEO of Soligenix with over 30 years of industry experience, has been at the firm since August 2006, ushering the company forward and growing the various verticals.

Soligenix's focus on developing and commercializing products to treat rare diseases and areas of unmet medical need may enable it to have a strong value proposition within the marketplace. The firm’s dual focus enables it to potentially have strong optionality within its product shelf, broadening its customer base and, it hopes, diversifying its revenue mix over time.

To learn more about Soligenix, click here.

Featured photo by National Cancer Institute on Unsplash.

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