HyBryte™治疗研究在三月份的两个医学会议上发表-动脉网

HyBryte™ Treatment Studies Presented at Two Medical Conferences in March

CISION 等信源发布 2025-03-06 20:30

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Two Presentations Highlight Data Demonstrating Hypericin Photodynamic Therapy Potential with a Preliminary Comparison to Current Therapy

两次展示突显了证明Hypericin光动力疗法潜力的数据，并初步对比了当前疗法。

PRINCETON, N.J.

普林斯顿，新泽西州

，

March 6, 2025

2025年3月6日

/PRNewswire/ -- Soligenix, Inc. (Nasdaq:

/PRNewswire/ -- 索利根尼克斯公司（纳斯达克：

SNGX

) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that its lead investigators for the cutaneous T-cell lymphoma (CTCL) and psoriasis programs are presenting findings from recent supportive trials with HyBryte™ (synthetic hypericin) in the treatment of CTCL and SGX302 (synthetic hypericin) in the treatment of mild-to-moderate psoriasis.

）（Soligenix或公司），一家专注于开发和商业化用于治疗存在未满足医疗需求的罕见病产品的后期生物制药公司，今天宣布其皮肤T细胞淋巴瘤（CTCL）和银屑病项目的主要研究人员正在展示近期HyBryte™（合成金丝桃素）在CTCL治疗中的支持性试验结果，以及SGX302（合成金丝桃素）在轻至中度银屑病治疗中的试验结果。

The presentations will occur at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (.

这些报告将在美国皮肤淋巴瘤联盟 (USCLC) 研讨会上进行。

March 6, 2025

2025年3月6日

) and the American Academy of Dermatology (AAD) Annual Meeting (

）和美国皮肤病学会（AAD）年会（

March 7-11, 2025

2025年3月7日至11日

）。

Ellen Kim

艾伦·金

, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the

医学博士，宾夕法尼亚皮肤淋巴瘤项目主任，皮肤病学系临床运营副主任，医院皮肤病学教授

University of Pennsylvania

宾夕法尼亚大学

, and who was the Principal Investigator for the first Phase 3 FLASH (

，谁是第一个 Phase 3 FLASH 的首席研究员 (

luorescent

荧光的

ight

光

ctivated

激活

ynthetic

合成的

ypericin) study, will present a poster at the USCLC detailing recent results from an ongoing

ypericin) 研究，将在 USCLC 上展示一张海报，详细介绍正在进行的研究的最新结果。

investigator-initiated study

研究者发起的研究

using HyBryte™ as a long-term treatment of CTCL.

使用HyBryte™作为CTCL的长期治疗。

Neal Bhatia

尼尔·巴蒂亚

, MD, FAAD, Director of Clinical Dermatology at Therapeutics Clinical Research and Principal Investigator of Study HPN-PSR-01, and who participated in the FLASH study, will present at the AAD and discuss general considerations on the use of topical and photodynamic therapy, including synthetic hypericin..

医学博士，FAAD，Therapeutics Clinical Research临床皮肤病学主任，HPN-PSR-01研究的首席研究员，并参与了FLASH研究，将在AAD上发表演讲，讨论局部和光动力疗法的使用的一般考虑因素，包括合成金丝桃素。

Presentations:

演示：

Conference:

会议：

USCLC Workshop 'Cutaneous Lymphomas in Special Populations'

美国皮肤淋巴瘤联盟研讨会“特殊人群中的皮肤淋巴瘤”

March 6

3月6日

，

Orlando, Florida

佛罗里达州奥兰多

。

The official conference program can be found

官方会议程序可以找到

here

这里

。

Presentation Title:

演示标题：

Topical hypericin ointment photodynamic therapy for early stage mycosis fungoides/CTCL – a Phase 2 real world investigator-initiated study

局部应用hypericin软膏光动力疗法治疗早期蕈样真菌病/CTCL——一项2期真实世界研究者发起的研究

presented by Dr.

由博士展示

Ellen Kim

艾伦·金

, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the

，宾夕法尼亚皮肤淋巴瘤项目主任，皮肤病学系临床运营副主任，医院皮肤病学教授，

University of Pennsylvania

宾夕法尼亚大学

。

Conference:

会议：

AAD Annual Meeting,

AAD年会，

March 7-11

3月7日-11日

，

Orlando, Florida

佛罗里达州奥兰多

Presentation Title:

演示标题：

What's new this year in Topical therapy?

今年局部治疗有什么新进展？

presented by Dr.

由博士呈现

Neal Bhatia

尼尔·巴蒂亚

, Director of Clinical Dermatology at Therapeutics Clinical Research and chief medical editor at Practical Dermatology. The official conference program can be found

，Therapeutics Clinical Research临床皮肤病学主任，Practical Dermatology首席医学编辑。官方会议程序可在此处找到。

here

这里

。

These presentations incorporate the Company's findings in recent supportive studies which have demonstrated the utility of

这些报告包含了公司近期支持性研究的发现，这些研究已经证明了实用性

longer treatment times

更长的治疗时间

(Study RW-HPN-MF-01; investigator-initiated study), the

（研究 RW-HPN-MF-01；研究者发起的研究），

lack of significant systemic exposure

缺乏显著的系统性暴露

to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability

局部应用后对黑素酸的反应（研究HPN-CTCL-02）及其相对疗效和耐受性

compared to Valchlor

与Valchlor相比

(Study HPN-CTCL-04).

（研究 HPN-CTCL-04）。

About the USCLC Workshop

关于USCLC研讨会

The United States Cutaneous Lymphoma Consortium is a multidisciplinary society of physicians which use collaborative research and education to improve the quality of life and prognosis of patients with cutaneous lymphoma. This workshop is held annually to facilitate collaboration. The meeting website is available .

美国皮肤淋巴瘤联盟是一个多学科的医生组织，他们通过合作研究和教育来改善皮肤淋巴瘤患者的生活质量和预后。该研讨会每年举办一次，以促进合作。会议网站可访问。

here

这里

。

About the AAD Annual Meeting

关于AAD年会

The American Academy of Dermatology Association Annual Meeting is one of the largest dermatologic scientific meetings globally and is attended by both researchers and dermatologists. The meeting website is available

美国皮肤病学会协会年会是全球最大的皮肤科科学会议之一，研究人员和皮肤科医生都会参加。会议网站可用。

here

这里

。

About HyBryte™ / Synthetic Hypericin

关于HyBryte™ /合成金丝桃素

HyBryte™ (research name SGX301 in CTCL, SGX302 in psoriasis) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later.

HyBryte™（在CTCL中的研究名称为SGX301，在牛皮癣中为SGX302）是一种新型的、首创的光动力疗法，利用安全的可见光进行激活。HyBryte™的活性成分是合成的金丝桃素，这是一种强效的光敏剂，通过局部应用于皮肤病变，被恶性T细胞吸收，然后在约24小时后由安全的可见光激活。

The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.

红色和黄色光谱中的可见光具有更深入穿透皮肤的优势（远超紫外线），因此可能治疗更深层的皮肤病、更厚的斑块和病灶。这种治疗方法避免了常用DNA损伤药物和其他依赖紫外线照射的光疗所带来的继发性恶性肿瘤（包括黑色素瘤）的风险。

Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.

结合光激活，金丝桃素对活化的正常人淋巴细胞显示出显著的抗增殖效果，并抑制了从CTCL患者中分离的恶性T细胞的生长。在一项已发表的CTCL二期临床研究中，患者使用局部金丝桃素治疗后获得了统计学上显著的改善（p=0.04），而安慰剂则无效。

HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA)..

HyBryte™ 已获得美国食品药品监督管理局 (FDA) 的孤儿药和快速通道资格，以及欧洲药品管理局 (EMA) 的孤儿药资格。

The

published Phase 3 FLASH trial

发表的第三阶段FLASH试验

enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions.

共纳入了169名患者（166名可评估），这些患者为IA、IB或IIA期CTCL。试验包括三个治疗周期。治疗在前6周内每周进行两次，并在每个周期的第8周末评估治疗反应。在第一个双盲治疗周期（第1周期）中，116名患者接受了HyBryte™治疗（0.25%合成金丝桃素），50名患者接受了安慰剂治疗针对其目标病灶。

A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint).

在第一个治疗周期（主要终点）期间，接受HyBryte™治疗的患者中有16%的患者达到了至少50%的病灶减少（使用皮肤病灶的标准测量方法CAILS评分进行评估），而安慰剂组在8周时仅有4%的患者达到这一效果（p=0.04）。

HyBryte™ treatment in this cycle was safe and well tolerated..

HyBryte™ 在本周期的治疗是安全且耐受性良好的。

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1).

在第二个开放标签治疗周期（周期2）中，所有患者均接受HyBryte™针对其目标病灶的治疗。对155名患者在该周期的评估显示（110名接受12周HyBryte™治疗，45名接受6周安慰剂治疗后接续6周HyBryte™治疗），12周治疗组的应答率为40%（p<0.0001，相较于周期1中的安慰剂治疗率）。

Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte™ continued to be safe and well tolerated. Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions in particular..

比较 12 周和 6 周的治疗反应后，还发现两个时间点之间存在统计学上的显著改善 (p<0.0001)，这表明持续治疗会带来更好的结果。HyBryte™ 仍然安全且耐受性良好。其他分析还表明，HyBryte™ 在治疗 CTCL 的斑块（反应率 42%，相对于第 1 周期的安慰剂治疗 p<0.0001）和斑片（反应率 37%，相对于第 1 周期的安慰剂治疗 p=0.0009）病变方面同样有效，这一发现尤其重要，因为历史上治疗斑块病变特别困难。

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1).

第三个（可选的）治疗周期（第三周期）专注于安全性，所有患者都可以选择接受HyBryte™对其所有病灶的治疗。值得注意的是，66%的患者选择继续参与这一可选的同情使用/安全周期研究。在接受了全部三个治疗周期HyBryte™治疗的患者子集中，49%的患者显示出积极的治疗反应（与第一周期接受安慰剂的患者相比，p<0.0001）。

Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions..

此外，在本周期评估的一部分患者中，已证明 HyBryte™ 无系统性吸收，这与迄今为止观察到的该外用产品的总体安全性一致。在第 3 周期结束时，尽管产品使用范围扩大且使用频率增加以治疗多个病灶，HyBryte™ 仍然具有良好的耐受性。

Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects.

HyBryte™ 的整体安全性是该治疗的关键属性，并在整个三个治疗周期（第1、2和3周期）以及6个月的随访期间进行了监测。HyBryte™ 的作用机制不会导致DNA损伤，这使其成为比目前可用疗法更安全的替代方案，现有疗法均伴随显著且有时致命的副作用。

Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available.

主要包括黑色素瘤和其他恶性肿瘤的风险，以及显著皮肤损伤和皮肤过早老化的风险。目前可用的治疗方法仅在其他治疗方式失败的情况下获批使用，尚无获批的首选一线疗法。

Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues..

在此背景下，CTCL的治疗很大程度上受到每种产品安全风险的影响。HyBryte™ 可能代表了目前最安全且有效的CTCL治疗方案。由于其系统吸收非常有限，化合物无致突变性，光源无致癌性，迄今为止没有任何潜在安全问题的证据。

Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, the Company initiated enrollment in .

在HyBryte™用于治疗CTCL的首个III期研究之后，FDA和EMA表示需要第二次成功的III期试验来支持上市批准。在与EMA就关键设计要素达成一致后，公司启动了第二个确证性研究FLASH2的患者招募工作。

December 2024

2024年12月

. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The

这是一项随机、双盲、安慰剂对照、多中心的研究，将招募大约80名早期CTCL患者。该研究将会...

FLASH

闪光灯

study

学习

replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1).

复制了首个成功的第三阶段FLASH研究中使用的双盲、安慰剂对照设计，该研究包括三个为期6周的治疗周期（总共18周），主要疗效评估在最初的6周双盲、安慰剂对照治疗周期（周期1）结束时进行。

However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of .

然而，这项第二项研究将双盲、安慰剂对照评估延长至18周。

continuous

连续的

treatment (no 'between-Cycle' treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy.

治疗（无“周期间”治疗中断），主要终点评估在18周时间点结束时进行。在第一项III期研究中，完成18周（3个周期）治疗的患者中观察到49%的治疗反应（p<0.0001，对比第一周期接受安慰剂的患者）。

In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte's™ increased effect over a more prolonged, 'real world' treatment course.

在这第二项研究中，所有重要的临床研究设计要素都与第一次FLASH研究相同，包括主要终点和关键的纳入-排除标准。单个周期内延长至连续18周的治疗预计将在统计学上证明HyBryte™在更长的“真实世界”治疗过程中的增强效果。

Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte™ patients from the FLASH study.

鉴于与CTCL社区的广泛接触、备受尊敬的医学顾问委员会以及之前针对该疾病的试验经验，预计这项研究将会加快受试者招募，包括有可能招募之前在FLASH研究中已确认并接受过HyBryte™治疗的患者。

Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study has begun enrolling patients.

与FDA就适当的研究设计进行的讨论仍在继续。尽管双方合作良好，但该机构表示更倾向于长时间的对照研究，而非安慰剂对照试验。鉴于较短的潜在商业收入时间，以及EMA接受的协议所提供的与首次FLASH研究相似的试验设计，本研究已开始招募患者。

At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback..

同时，将与FDA继续讨论可能的开发路径修改方案，以充分解决他们的反馈意见。

Additional supportive studies have demonstrated the utility of

其他支持性研究已经证明了其效用

longer treatment times

更长的治疗时间

(Study RW-HPN-MF-01), the

（研究 RW-HPN-MF-01），

lack of significant systemic exposure

缺乏显著的系统性暴露

to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability

局部应用后对黑素酸的反应（研究HPN-CTCL-02）及其相对疗效和耐受性

compared to Valchlor

与Valchlor相比

(Study HPN-CTCL-04).

（研究 HPN-CTCL-04）。

In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling

此外，FDA授予了一项孤儿产品开发补助金，以支持研究者发起的HyBryte™评估研究，用于早期CTCL患者的扩展治疗，包括在家庭使用环境中的应用。该补助金总计

$2.6 million

260万美元

over 4 years, was awarded to the

超过4年，被授予了

University of Pennsylvania

宾夕法尼亚大学

that was a leading enroller in the Phase 3 FLASH study.

这是在第三阶段FLASH研究中的主要注册者。

About Cutaneous T-Cell Lymphoma (CTCL)

关于皮肤T细胞淋巴瘤（CTCL）

CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin.

CTCL是一类非霍奇金淋巴瘤（NHL），这是一种涉及作为免疫系统重要组成部分的白细胞的癌症。与大多数通常涉及B细胞淋巴细胞（负责产生抗体）的NHL不同，CTCL是由恶性T细胞淋巴细胞的扩增引起的，这些细胞通常被编程迁移到皮肤，参与细胞介导的免疫反应。

These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced.

这些恶性细胞迁移到皮肤，在那里形成各种病变，通常开始为斑块，并可能发展为隆起的斑块和肿瘤。CTCL的死亡率与其阶段相关，早期的中位生存期一般约为12年，而当疾病进展时，仅为2.5年。

There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas..

目前，CTCL尚无治愈方法。通常，CTCL病灶会接受治疗并消退，但通常会在身体的相同部位或新区域复发。

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and

CTCL构成了NHL的一个罕见群体，在美国超过170万患者中，约有4%的人患有该疾病。

Europe

欧洲

(European Union and

（欧盟和

United Kingdom

英国

). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in .

）。据估计，基于对历史已发表研究和报告的回顾以及对CTCL发病率数据的插值，美国约有31,000人受到影响（基于SEER数据，每年约新增3,200例），全球范围内约有38,000人受到影响。

Europe

欧洲

(based on ECIS prevalence estimates, with approximately 3,800 new cases annually).

（基于ECIS的流行率估计，每年大约有3800个新病例）。

About Psoriasis

关于银屑病

Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide.

银屑病是一种慢性、非传染性、瘙痒且常伴有疼痛的炎症性皮肤病，目前尚无治愈方法。银屑病对患者的生活质量有显著的负面影响，并与心血管疾病、关节炎、代谢性疾病以及焦虑、抑郁和自杀等心理问题密切相关。

Many factors contribute to development of psoriasis including both genetic and environmental factors (e.g., skin trauma, infections, and medications). The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back.

许多因素会导致银屑病的发展，包括遗传因素和环境因素（例如，皮肤创伤、感染和药物）。病变的发生是由于自身免疫T细胞介导的炎症导致皮肤细胞迅速增殖。在各种类型的银屑病中，斑块型银屑病最为常见，其特征是干燥、红色隆起的斑块，表面覆盖有银白色鳞屑，最常见于肘部、膝盖、头皮和下背部。

Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability.

大约80%的患者病情属于轻度至中度。轻度银屑病通常表现为体表面积（BSA）受累不足3%，而中度银屑病通常涉及3%-10%的BSA，重度银屑病则超过10%的BSA。在银屑病患者中，约20%至30%的人会发展为慢性炎症性关节炎（银屑病关节炎），这可能导致关节变形和残疾。

Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35..

研究还表明，银屑病，尤其是严重的银屑病，与淋巴瘤（特别是CTCL）的相对风险增加有关。虽然银屑病可以在任何年龄发生，但大多数患者在35岁之前出现症状。

Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease.

银屑病的治疗基于就诊时的严重程度，目标是控制症状。治疗方案从局部治疗选项（包括光动力疗法以减轻疼痛和瘙痒，并可能减少引发斑块形成的炎症）到针对更严重病情的系统性治疗不等。

Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B light, carry a risk of increased skin cancer..

最常见的全身性治疗，甚至目前的局部光/光动力疗法，如紫外线A和B光，都带有增加皮肤癌的风险。

Psoriasis is the most common immune-mediated inflammatory skin disease. According to the

银屑病是最常见的免疫介导的炎症性皮肤病。根据

World Health Organization (WHO) Global Report on Psoriasis 2016

世界卫生组织（WHO）2016年全球银屑病报告

, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data, that psoriasis affects 3% of the U.S. population or more than 7.5 million people.

，在大多数发达国家，银屑病的患病率在1.5%到5%之间，有研究表明其发病率可能随着时间的推移而增加。基于对历史研究和报告的回顾以及数据的推算，估计银屑病影响着美国3%的人口，即超过750万人。

Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027..

目前的估计显示，全球有6000万至1.25亿人患有此病。2020年全球银屑病治疗市场价值约为150亿美元，预计到2027年可能达到400亿美元。

About Soligenix, Inc.

关于索利基因股份有限公司

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL).

Soligenix是一家处于后期阶段的生物制药公司，专注于开发和商业化用于治疗存在未满足医疗需求的罕见疾病的产品。我们的特种生物治疗业务部门正在开发并朝着潜在商业化HyBryte™（SGX301或合成金丝桃素钠）迈进，这是一种利用安全可见光治疗皮肤T细胞淋巴瘤（CTCL）的新型光动力疗法。

With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease..

随着第二项III期研究的成功完成，将寻求监管批准以支持全球潜在的商业化。该业务板块的开发计划还包括将合成金丝桃素（SGX302）扩展到银屑病领域，我们的一流先天防御调节剂（IDR）技术，dusquetide（SGX942）用于治疗炎症性疾病，包括头颈癌中的口腔黏膜炎，以及（SGX945）在贝赫切特病中的应用。

Our Public Health Solutions business segment includes development programs for RiVax

我们的公共卫生解决方案业务部门包括RiVax的开发计划。

, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax.

，我们的蓖麻毒素疫苗候选物，以及针对丝状病毒（如马尔堡病毒和埃博拉病毒）和CiVax™的疫苗项目，CiVax™是我们用于预防由SARS-CoV-2引起的COVID-19的疫苗候选物。我们的疫苗项目的开发融合了我们专有的热稳定平台技术，即ThermoVax。

. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).

迄今为止，这一业务领域得到了来自国家过敏与传染病研究所 (NIAID)、国防威胁降低局 (DTRA) 以及生物医学高级研究与发展管理局 (BARDA) 的政府拨款和合同资金的支持。

For further information regarding Soligenix, Inc., please visit the Company's website at

有关Soligenix, Inc.的更多信息，请访问公司网站

https://www.soligenix.com

and follow us on

并关注我们

领英

and Twitter at

以及 Twitter 在

@Soligenix_Inc

@索利根公司

。

This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment, the expected timing for closing the offering described herein and the intended use of proceeds therefrom.

本新闻稿可能包含反映Soligenix对其未来结果、业绩、前景和机会的当前预期的前瞻性陈述，包括但不限于潜在市场规模、患者群体、临床试验入组情况、本文所述发行结束的预期时间以及所得款项的预期用途。

Statements that are not historical facts, such as 'anticipates,' 'estimates,' 'believes,' 'hopes,' 'intends,' 'plans,' 'expects,' 'goal,' 'may,' 'suggest,' 'will,' 'potential,' or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering.

并非历史事实的陈述，例如“预期”、“估计”、“相信”、“希望”、“打算”、“计划”、“预计”、“目标”、“可能”、“暗示”、“将”、“潜在”或类似表述，均为前瞻性陈述。这些陈述受多种风险、不确定性及其他因素的影响，可能导致未来期间的实际事件或结果与这些陈述中表达或暗示的内容有重大差异，其中包括本次发行的预期金额及所得款项用途以及本次发行的预期完成日期。

Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants.

Soligenix无法向您保证它将能够成功开发、获得监管批准或将其技术基础上的产品商业化，特别是鉴于在开发生物恐怖威胁的治疗药物和疫苗、进行治疗药物和疫苗的临床前和临床试验、获得监管批准以及生产治疗药物和疫苗方面存在重大不确定性，产品开发和商业化工作不会因临床试验中的困难或延迟或由于研发工作缺乏进展或积极结果而减少或终止，它将能够成功获得任何进一步的资金来支持产品开发和商业化工作，包括资助和奖励，并维持其现有的资助。

will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax

将有资格获得生物防御优先审查券（PRV），或者之前PRV的销售情况能够表明RiVax的PRV潜在销售价格。

. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the 'SEC'), including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.

此外，无法保证公司将收到或继续收到来自已授予或可能授予的拨款和合同的非稀释性政府资金，也无法保证公司未来申请的资金。这些及其他风险因素会不时在向证券交易委员会（“SEC”）提交的文件中描述，包括但不限于Soligenix的10-Q和10-K表格报告。

Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events..

除非法律要求，Soligenix 不承担因新信息或未来事件而更新或修改任何前瞻性声明的义务。

SOURCE SOLIGENIX, INC.

来源：索利吉尼克斯公司

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