Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances (e.g., Orphan Drug designation, Fast Track designation, use of adaptive trial designs, etc.) and clinical execution (specialized recruitment approaches, direct site interactions, etc.). Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in personal contact with the sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets.
Soligenix has two areas of focus: 1) a specialized therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as cutaneous T-cell lymphoma, oral mucositis, pediatric Crohn’s disease, and acute radiation enteritis, and 2) a public health segment involving vaccine and biodefense applications with specific programs in the prevention of ricin intoxication, the treatment of acute radiation syndrome, and the prevention/treatment of emerging and antibiotic resistant infectious disease. Soligenix’s major programs are reviewed in our corporate presentation.
Soligenix is focusing on two key programs, with an additional two earlier stage programs:
SGX301 is a photodynamic topical therapy using a hypericin ointment activated by visible light which is intended for patients managing early stage CTCL disease progression. SGX301 has been granted both Orphan Drug and Fast Track designation in the US, Orphan Drug designation in Europe and Promising Innovative Medicine designation by the UK Health Authority.
A Phase 3 clinical study (FLASH – Fluorescent Light Activated Synthetic Hypericin) has announced positive topline results with study follow-up ongoing. Stay tuned for more information. This study involved may of the key opinion leaders in CTCL.
SGX942 contains the active ingredient dusquetide, a novel Innate Defense Regulator (IDR). IDRs modulate inflammation, enhance tissue healing and prevent and treat infection, all central issues in the development and progression of oral mucositis. SGX942 has been granted Fast Track designation in the US and Promising Innovative Medicine designation by the UK Health Authority.
We have completed enrolling a multi-national Phase 3 trial (DOM-INNATE – Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) in the US and Europe. Topline results are expected in Q4 2020. More to come!
SGX203 involves a proprietary oral formulation of the corticosteroid beclomethasone dipropionate (BDP) to provide comprehensive topical anti-inflammatory treatment of the gastrointestinal tract. SGX203 has been granted Orphan Drug and Fast Track designations in the US. We have negotiated a comprehensive Phase 3 trial with the FDA for conduct of the study. Study initiation is pending partnership/additional funding.
Using the same active ingredient as SGX203, SGX201 is an oral formulation targeted at the lower gastrointestinal tract to mitigate the impact of radiation therapy applied to the pelvic area during cancer treatment. SGX201 has Fast Track designation in the US. With the completion of an initial Phase 1/2 study, the SGX201 program is pending additional partnership/funding.
Public Health Solutions
Within our Public Health Solutions segment, Soligenix is primarily focusing on our ricin toxin vaccine program, with other programs pending identification of additional non-dilutive funding sources (e.g., government grants and contracts).
RiVax® is a subunit protein vaccine candidate which is thermostabilized with our proprietary ThermoVax® technology, yielding an easily stored and transported vaccine which does not require refrigeration or freezing, has a long shelf life and has shown an excellent safety profile in clinical trials. RiVax® has the potential to be awarded an FDA Priority Review Voucher upon approval and is targeted for use in military personnel and civilian emergency responders. RiVax® has been granted Orphan Drug designation in the US and Europe. We are currently planning to initiate a Phase 2 clinical study to further test the safety and immunogenicity of RiVax® while also collecting efficacy data in animals to facilitate approval under the FDA Animal Rule.
ThermoVax® is a proprietary heat stabilization platform which allows subunit protein vaccines to be co-lyophilized with alum – yielding an adjuvanted, thermostable powder which can be reconstituted with water for injection immediately prior to use. This unique formulation allows for ambient storage of the vaccines for extended periods of time, foregoing requirements for cold chain storage and shipping. ThermoVax® has been incorporated into the RiVax® product candidate, with additional proof of concept generated with Ebola and HPV vaccines.
SGX943 contains the same active ingredient, dusquetide, as SGX942. The anti-infective action of SGX943, increasing the innate immune response to infection while still controlling inflammation, is of significant importance in many serious infections, where the inflammation is as life-threatening as the infection itself. Because SGX943 interacts with the immune system, and does not directly kill the bacteria, it has been shown to be effective in clinical trials irrespective of the type of bacteria involved or any antibiotic resistance which may have developed. SGX943 has received Fast Track designation in the US for the treatment of melioidosis (a bacterial infection caused by the bacteria Burkholderia pseudomallei).