PRINCETON, N.J., Oct. 12, 2021 /PRNewswire/ — Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Firm), a late-stage biopharmaceutical firm centered on growing and commercializing merchandise to deal with uncommon ailments the place there may be an unmet medical want, introduced at the moment their poster summary was chosen as a “high summary winner” and has been accepted for show and presentation on the 2021 Nationwide Group for Uncommon Problems (NORD) Uncommon Ailments and Orphan Merchandise Breakthrough Summit to be held just about on October 18-19, 2021. Christopher Pullion, DO, Soligenix’s Medical Director, will current the constructive Part 3 outcomes with HyBryte™ (hypericin ointment 0.25%) within the context of the broader cutaneous T-cell lymphoma (CTCL) therapy panorama. The FLASH (Fluorescent Light Activated Synthetic Hypericin) trial is the biggest multicenter, randomized, double-blind, placebo-controlled, skin-directed remedy examine in CTCL to this point, enrolling a complete of 169 evaluable sufferers.
Oral/Poster Presentation:
Part 3 Efficacy with a Novel, First in Class, Properly-Tolerated Photodynamic Remedy (HyBryte™) for Early Stage Cutaneous T-Cell Lymphoma. Dr. Pullion’s presentation will likely be accessible to view beginning on October 18, 2021 and can stay accessible to view till November 19, 2021. Attendees may even be capable of meet with Dr. Pullion to debate the presentation reside at a number of instances in the course of the two-day occasion. Solely registered attendees can view and take part on this digital convention. Attendees can register for the NORD Summit here.
“To be chosen to current our scientific trial information and overview it within the context of its potential impression to sufferers at this 12 months’s NORD summit is a real honor,” famous Dr. Pullion. “Conducting analysis within the uncommon illness panorama is simply doable by means of shut collaboration with affected person advocacy teams, comparable to NORD and the Cutaneous Lymphoma Basis, and the sufferers they serve. It’s great to have the ability to share with them the outcomes of such a profitable collaboration and element why we expect HyBryte, with its constructive security and efficacy profile, will symbolize a promising new therapy choice on this troublesome to deal with and continual most cancers. I wish to thank all our taking part sufferers and physicians who made this groundbreaking examine doable.”
In regards to the Nationwide Group for Uncommon Problems
The Uncommon Ailments and Orphan Merchandise Breakthrough Summit brings collectively members of the uncommon illness group. The aim is to permit illness consultants and leaders from affected person advocacy teams, authorities, trade, and academia to unlock new insights, community in a constructive digital atmosphere, and focus on essential subjects within the uncommon ailments and orphan merchandise subject. NORD, is a affected person advocacy group devoted to people with uncommon ailments and the organizations that serve them. NORD, together with its greater than 300 affected person group members, is dedicated to the identification, therapy, and remedy of uncommon problems by means of applications of schooling, advocacy, analysis, and affected person providers.
About HyBryte™
HyBryte™ (SGX301) is a novel, first-in-class, photodynamic remedy using secure, seen gentle for activation. The lively ingredient in HyBryte™ is artificial hypericin, a potent photosensitizer that’s topically utilized to pores and skin lesions that’s taken up by the malignant T-cells, after which activated by seen gentle 16 to 24 hours later. The usage of seen gentle within the red-yellow spectrum has the benefit of penetrating extra deeply into the pores and skin (far more so than ultraviolet gentle) and due to this fact doubtlessly treating deeper pores and skin illness and thicker plaques and lesions. This therapy method avoids the chance of secondary malignancies (together with melanoma) inherent with the incessantly employed DNA-damaging medication and different phototherapy which might be depending on ultraviolet publicity. Mixed with photoactivation, hypericin has demonstrated important anti-proliferative results on activated regular human lymphoid cells and inhibited progress of malignant T-cells remoted from CTCL sufferers. In a broadcast Part 2 scientific examine in CTCL, sufferers skilled a statistically important (p=0.04) enchancment with topical hypericin therapy whereas the placebo was ineffective. HyBryte™ has acquired orphan drug and quick monitor designations from the FDA, in addition to orphan designation from the European Medicines Company (EMA).
The Part 3 FLASH trial enrolled a complete of 169 sufferers (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three therapy cycles. Remedies had been administered twice weekly for the primary 6 weeks and therapy response was decided on the finish of the eighth week of every cycle. Within the first double-blind therapy cycle, 116 sufferers acquired HyBryte™ therapy (0.25% artificial hypericin) and 50 acquired placebo therapy of their index lesions. A complete of 16% of the sufferers receiving HyBryte™ achieved not less than a 50% discount of their lesions (graded utilizing an ordinary measurement of dermatologic lesions, the CAILS rating) in comparison with solely 4% of sufferers within the placebo group at 8 weeks (p=0.04) in the course of the first therapy cycle (main endpoint). HyBryte™ therapy within the first cycle was secure and properly tolerated.
Within the second open-label therapy cycle (Cycle 2), all sufferers acquired HyBryte™ therapy of their index lesions. Analysis of 155 sufferers on this cycle (110 receiving 12 weeks of HyBryte™ therapy and 45 receiving 6 weeks of placebo therapy adopted by 6 weeks of HyBryte™ therapy), demonstrated that the response fee among the many 12-week therapy group was 40% (p<0.0001 vs the placebo therapy fee in Cycle 1). Comparability of the 12-week and 6-week therapy teams additionally revealed a statistically important enchancment (p<0.0001) between the 2 teams, indicating that continued therapy leads to higher outcomes. HyBryte™ continued to be secure and properly tolerated. Further analyses additionally indicated that HyBryte™ is equally efficient in treating each plaque (response 42%, p<0.0001 relative to placebo therapy in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo therapy in Cycle 1) lesions of CTCL, a very related discovering given the historic problem in treating plaque lesions particularly.
The third (non-compulsory) therapy cycle (Cycle 3) was centered on security and all sufferers might elect to obtain HyBryte™ treatment of all their lesions. Of observe, 66% of sufferers elected to proceed with this non-compulsory compassionate use / security cycle of the examine. Of the subset of sufferers that acquired HyBryte™ all through all 3 cycles of therapy, 49% of them demonstrated a therapy response (p<0.0001 vs sufferers receiving placebo in Cycle 1). Furthermore, in a subset of sufferers evaluated on this cycle, it was demonstrated that HyBryte™ will not be systemically accessible, in step with the final security of this topical product noticed to this point. On the finish of Cycle 3, HyBryte™ continued to be properly tolerated regardless of prolonged and elevated use of the product to deal with a number of lesions.
Total security of HyBryte™ is a essential attribute of this therapy and was monitored all through the three therapy cycles (Cycles 1, 2 and three) and the 6-month follow-up interval. Its mechanism of motion will not be related to DNA harm, making it a safer various than at the moment accessible therapies, all of that are related to important and generally deadly, unwanted side effects. Predominantly these embody the chance of melanoma and different malignancies, in addition to the chance of serious pores and skin harm and untimely pores and skin getting old. At the moment accessible remedies are solely accredited within the context of earlier therapy failure with different modalities and there’s no accredited front-line remedy accessible. Inside this panorama, therapy of CTCL is strongly motivated by the protection threat of every product. HyBryte™ doubtlessly represents the most secure accessible efficacious therapy for CTCL. With no systemic absorption, a compound that isn’t mutagenic and a light-weight supply that isn’t carcinogenic, there isn’t any proof to this point of any potential issues of safety.
The Part 3 CTCL scientific examine was partially funded by the Nationwide Most cancers Institute by way of a Part II Small Enterprise Innovation Analysis (SBIR) grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical firm centered on growing and commercializing merchandise to deal with uncommon ailments the place there may be an unmet medical want. Our Specialised BioTherapeutics enterprise section is growing and commercializing SGX301 (artificial hypericin) as a novel photodynamic remedy using secure seen gentle for the therapy of cutaneous T-cell lymphoma. With a profitable Part 3 examine accomplished, regulatory approval and commercialization for this product is being superior initially within the U.S. Improvement applications on this enterprise section additionally embody growth of artificial hypericin (SGX302) into psoriasis, our first-in-class innate protection regulator (IDR) know-how, dusquetide (SGX942) for the therapy of inflammatory ailments, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention / therapy of gastrointestinal (GI) problems characterised by extreme irritation, together with pediatric Crohn’s illness (SGX203).
Our Public Well being Options enterprise section consists of lively growth applications for RiVax®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and rising infectious illness, and our analysis applications to establish and develop novel vaccine candidates concentrating on viral an infection together with Ebola, Marburg and SARS-CoV-2 (the reason for COVID-19). The event of our vaccine applications incorporates using our proprietary warmth stabilization platform know-how, often known as ThermoVax®. So far, this enterprise section has been supported with authorities grant and contract funding from the Nationwide Institute of Allergy and Infectious Ailments (NIAID), the Protection Risk Discount Company (DTRA) and the Biomedical Superior Analysis and Improvement Authority (BARDA).
For additional info relating to Soligenix, Inc., please go to the Firm’s web site at https://www.soligenix.com and comply with us on LinkedIn and Twitter at @Soligenix_Inc.
This press launch could include forward-looking statements that replicate Soligenix, Inc.’s present expectations about its future outcomes, efficiency, prospects and alternatives, together with however not restricted to, potential market sizes, affected person populations and scientific trial enrollment. Statements that aren’t historic details, comparable to “anticipates,” “estimates,” “believes,” “hopes,” “intends,” “plans,” “expects,” “purpose,” “could,” “recommend,” “will,” “potential,” or related expressions, are forward-looking statements. These statements are topic to quite a few dangers, uncertainties and different elements that would trigger precise occasions or leads to future durations to vary materially from what’s expressed in, or implied by, these statements, comparable to skilled with the COVID-19 outbreak. Soligenix can not guarantee you that it will likely be capable of efficiently develop, obtain regulatory approval for or commercialize merchandise primarily based on its applied sciences, significantly in gentle of the numerous uncertainty inherent in growing therapeutics and vaccines in opposition to bioterror threats, conducting preclinical and scientific trials of therapeutics and vaccines, acquiring regulatory approvals and manufacturing therapeutics and vaccines, that product growth and commercialization efforts is not going to be decreased or discontinued because of difficulties or delays in scientific trials or because of lack of progress or constructive outcomes from analysis and growth efforts, that it will likely be capable of efficiently acquire any additional funding to help product growth and commercialization efforts, together with grants and awards, preserve its present grants that are topic to efficiency necessities, enter into any biodefense procurement contracts with the U.S. Authorities or different nations, that it will likely be capable of compete with bigger and higher financed rivals within the biotechnology trade, that adjustments in well being care observe, third get together reimbursement limitations and Federal and/or state well being care reform initiatives is not going to negatively have an effect on its enterprise, or that the U.S. Congress could not go any laws that would offer extra funding for the Mission BioShield program. As well as, there might be no assurance as to the timing or success of any of its scientific/preclinical trials. Regardless of the statistically important consequence achieved within the HyBryte™ (SGX301) Part 3 scientific trial for the therapy of cutaneous T-cell lymphoma, there might be no assurance {that a} advertising and marketing authorization from the FDA or EMA will likely be profitable. However the consequence within the HyBryte™ (SGX301) Part 3 scientific trial for the therapy of cutaneous T-cell lymphoma and the Part 1/2 proof-of-concept scientific trial of SGX302 for the therapy of psoriasis, there might be no assurance as to the timing or success of the scientific trials of SGX302 for the therapy of psoriasis. Additional, there might be no assurance that RiVax® will qualify for a biodefense Precedence Overview Voucher (PRV) or that the prior gross sales of PRVs will likely be indicative of any potential gross sales value for a PRV for RiVax®. Additionally, no assurance might be supplied that the Firm will obtain or proceed to obtain non-dilutive authorities funding from grants and contracts which were or could also be awarded or for which the Firm will apply sooner or later. These and different threat elements are described occasionally in filings with the Securities and Alternate Fee, together with, however not restricted to, Soligenix’s studies on Varieties 10-Q and 10-Ok. Until required by regulation, Soligenix assumes no obligation to replace or revise any forward-looking statements because of new info or future occasions.
SOURCE Soligenix, Inc.
