Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, is pleased to announce that the United States (US) Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for .

澳大利亚悉尼，2025年2月19日 — Clarity Pharmaceuticals（ASX：CU6）（“Clarity”或“公司”），一家致力于开发下一代产品以改善儿童和成人癌症治疗效果的临床阶段放射性药物公司，欣然宣布美国食品药品监督管理局（FDA）已授予其快速通道资格（FTD）。

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Cu-SAR-bisPSMA for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with androgen receptor pathway inhibition (ARPI).

Cu-SAR-bisPSMA 用于治疗先前接受过雄激素受体通路抑制剂（ARPI）治疗的前列腺特异性膜抗原（PSMA）阳性的转移性去势抵抗性前列腺癌（mCRPC）成年患者。

This milestone builds on Clarity’s earlier receipt of 2 FTDs for the diagnostic

这一里程碑建立在Clarity早先获得的2个FTD诊断基础上

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Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy

疑似前列腺癌转移且适合初次根治性治疗的患者中的Cu-SAR-bisPSMA

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, as well as patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy

以及在接受确定性治疗后生化复发（BCR）的前列腺癌患者

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, with 2 Phase III registration trials underway (CLARIFY [NCT06056830]

，目前正在进行两项 III 期注册试验（CLARIFY [NCT06056830]

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and AMPLIFY, respectively). These 3 FTDs demonstrate the quality of the data generated to date on the

和 AMPLIFY，分别）。这 3 个 FTD 展示了迄今为止生成的数据质量。

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Cu-SAR-bisPSMA and

Cu-SAR-bisPSMA 和

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Cu-SAR-bisPSMA products in addressing serious unmet needs in prostate cancer. The FTDs will enable Clarity to accelerate the development of its comprehensive program with the optimised SAR-bisPSMA agent to be used in patients with prostate cancer throughout the management of their cancer, from initial to late-stage disease, with an opportunity to completely change the entire treatment landscape for the large prostate cancer market..

Cu-SAR-bisPSMA产品在应对前列腺癌中未满足的严重需求。FTDs将使Clarity能够加速其全面计划的开发，优化的SAR-bisPSMA药物将用于前列腺癌患者，贯穿他们从初期到晚期的整个癌症管理过程，并有机会彻底改变庞大的前列腺癌市场的整体治疗格局。

The FDA’s FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For SAR-bisPSMA, it provides a number of product development advantages. The designations pave the way for a faster review process once Clarity submits its product approval applications.

FDA的快速通道资格（FTD）旨在加速针对严重疾病且具有显著未满足医疗需求的新型药物的开发和监管审评。对于SAR-bisPSMA而言，它提供了多项产品开发优势。该认定为Clarity提交产品批准申请后更快的审评流程铺平了道路。

Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA.

此外，它还能够更频繁地与FDA进行沟通，以便在开发过程中快速解决疑问。此外，Clarity可以提交已完成的申请部分，而无需等待整个申请包完成后再提交给FDA。

These benefits would reduce the review time needed to bring this innovative and proprietary molecule to the prostate cancer imaging and therapy markets..

这些好处将减少将这种创新的、专有的分子引入前列腺癌成像和治疗市场所需的审查时间。

The data for this FTD submission was based on the preliminary results to date from the Phase I/IIa SECuRE study (NCT04868604)

该FTD提交的数据基于I/IIa期SECuRE研究（NCT04868604）迄今为止的初步结果。

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, which is investigating the safety and efficacy of

，该研究正在调查安全性和有效性

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Cu-SAR-bisPSMA for the treatment of mCRPC patients. The first 3 cohorts in the dose escalation phase of the trial were successfully completed with no dose limiting toxicities (DLTs) reported in any of the participants dosed (15 participants). No adverse events (AEs) related to

用于治疗mCRPC患者的Cu-SAR-bisPSMA。试验剂量递增阶段的前3个队列已成功完成，未报告任何受试者（15名参与者）出现剂量限制性毒性（DLTs）。未发生与治疗相关的不良事件（AEs）。

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Cu-SAR-bisPSMA were observed. Most AEs related to

观察到了Cu-SAR-bisPSMA。大多数AEs与

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Cu-SAR-bisPSMA were low grade (grade 1 or 2). The most common AE reported was mild dry mouth (grade 1, 5/15 participants, 33.3%).

Cu-SAR-bisPSMA的不良反应为低级别（1级或2级）。最常见的不良事件是轻度口干（1级，15名参与者中有5人，占33.3%）。

Preliminary data shows that the majority of participants in the SECuRE study enrolled to date had bone metastasis (77%), high median prostate-specific antigen (PSA) level at baseline (112.86 ng/mL, range 0.1-1503.1) and were heavily pre-treated (59% of participants received 3 or more lines of therapy).

初步数据显示，迄今为止，SECuRE 研究中大多数参与者患有骨转移（77%），基线时前列腺特异性抗原（PSA）水平中位数较高（112.86 ng/mL，范围 0.1-1503.1），并且接受过多次治疗（59% 的参与者接受了 3 种或更多种疗法）。

Despite how heavily pre-treated these participants were, and how much disease they had, 73% of them across all cohorts (including the lowest dose cohort of .

尽管这些参与者接受了大量的预处理，并且疾病程度很高，但所有队列中73%的参与者（包括最低剂量队列）。

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Cu-SAR-bisPSMA at 4 GBq, single dose) showed reductions in PSA levels. The majority of patients that had an increase in PSA were on the single, lowest dose cohort 1 (4 GBq). PSA reductions of greater than 50% were seen in 45% of all trial participants, despite the overwhelming majority of participants only receiving a single dose of .

Cu-SAR-bisPSMA在4 GBq的单剂量下显示出PSA水平的下降。大多数PSA升高的患者属于最低剂量组1（4 GBq）。尽管绝大多数参与者只接受了一次剂量，但45%的试验参与者PSA水平下降超过50%。

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Cu-SAR-bisPSMA (4, 8 or 12 GBq) in the trial. In cohorts 2, 3 and 4 (8 and 12 GBq single dose and 12 GBq multi-dose, respectively), in which most participants also only received 1 dose of

Cu-SAR-bisPSMA（4、8 或 12 GBq）在试验中。在第2、3和4组（分别为8和12 GBq单剂量以及12 GBq多剂量），其中大多数参与者也只接受了1次剂量

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Cu-SAR-bisPSMA, PSA reductions of greater than 35% were observed in almost 75% of participants and PSA was reduced by 80% or more in almost half of the participants so far, as patients continue in follow-up.

Cu-SAR-bisPSMA，近75%的参与者观察到PSA降低超过35%，近一半的参与者的PSA降低了80%或更多，随着患者继续随访。

The trial is currently progressing through the highest dose cohort where participants were administered multiple doses of 12 GBq of

试验目前正在进行最高剂量组的测试，参与者被施用了多次12 GBq的剂量

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Cu-SAR-bisPSMA. Recruitment into cohort 4 is complete, and the remaining 3 participants are currently in the safety and efficacy follow-up period after receiving their first 2 doses. Following completion of the follow-up up period, the safety review committee meeting is planned for March 2025. The largest drop in prostate-specific antigen (PSA) in cohort 4 to date is a decline of 98% (from a baseline of 157.4 ng/mL).

Cu-SAR-bisPSMA。第4组的招募已经完成，剩下的3名参与者目前在接种前两剂后的安全性和有效性随访期。随访期结束后，计划于2025年3月召开安全审查委员会会议。截至目前，第4组前列腺特异性抗原（PSA）的最大降幅为98%（从基线157.4 ng/mL下降）。

This participant, who had failed multiple lines of therapy prior to receiving .

该参与者在接收之前已失败多线治疗。

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Cu-SAR-bisPSMA (androgen deprivation therapy [ADT], ARPI and an investigational agent), has already had a radiographic partial response based on the investigator’s assessment of Response Evaluation Criteria in Solid Tumours v1.1 (RECIST) criteria. Preliminary analysis showed a reduction of 60.6% in tumour volume evaluated by PSMA positron emission tomography [PET] imaging with .

Cu-SAR-bisPSMA（雄激素剥夺疗法 [ADT]、ARPI 和一种研究性药物）根据研究者对实体瘤反应评估标准 v1.1 (RECIST) 的评估，已经显示出影像学部分缓解。初步分析显示，通过 PSMA 正电子发射断层扫描 [PET] 成像评估，肿瘤体积减少了 60.6%。

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Cu-SAR-bisPSMA (

Cu-SAR-bisPSMA (

Figure 1

图1

).

）。

Figure 1

图1

. mCRPC patient from cohort 4 showing extensive metastasis of prostate cancer to the lymph nodes (regions highlighted by the red lines). Considerable reduction in tumour volume (60.6%) observed following 2 doses of

来自队列4的mCRPC患者，显示前列腺癌广泛转移至淋巴结（红色线条标示区域）。在两剂治疗后观察到肿瘤体积显著减少（60.6%）。

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Cu-SAR-bisPSMA (PSMA-avid tumour burden reduction assessed by

Cu-SAR-bisPSMA（通过PSMA评估的肿瘤负担减少）

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Cu-SAR-bisPSMA PET). Images shown as maximum intensity projections.

Cu-SAR-bisPSMA PET）。图像显示为最大强度投影。

Cohort expansion of the SECuRE trial to assess the combination of

SECuRE试验的队列扩展以评估组合

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Cu-SAR-bisPSMA with enzalutamide

Cu-SAR-bisPSMA 与恩杂鲁胺

For a long time, Clarity has been working closely with many important global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, to optimise the development of all of its products in prostate cancer. Those discussions have led to a recent protocol amendment for the SECuRE trial, which aims to investigate ways to further improve the treatment outcomes for these patients.

长时间以来，Clarity 一直与许多全球重要的前列腺癌领域医学专家密切合作，包括公司临床顾问委员会成员Louise Emmett教授和Oliver Sartor教授，以优化其在前列腺癌领域的所有产品开发。这些讨论促成了SECuRE试验最近的方案修订，该试验旨在研究进一步改善这些患者治疗效果的方法。

The protocol amendment is aligned with the positive results of the Enza-p trial presented by Prof Emmett first at the European Society for Medical Oncology in 2023.

该协议修正案与Emmett教授于2023年在欧洲肿瘤内科学会首次展示的Enza-p试验的积极结果保持一致。

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and more recently at the American Society of Clinical Oncology Genitourinary Cancers (ASCO GU) Symposium in 2025

以及最近在2025年美国临床肿瘤学会泌尿生殖系统癌症（ASCO GU）研讨会上

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, which confirmed the hypothesis that targeting both androgen signalling and PSMA receptors concurrently would improve anti-cancer activity in mCRPC. The latest SECuRE protocol amendment increased the number of participants in the cohort expansion phase from 14 to 24 patients in the mCRPC pre-chemotherapy setting, with a subset of patients to receive the combination therapy of .

，该研究证实了同时靶向雄激素信号和PSMA受体能够提高mCRPC中的抗癌活性的假设。最新的SECuRE方案修正案将mCRPC化疗前队列扩展阶段的参与者数量从14名增加到24名患者，其中一部分患者将接受联合治疗。

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Cu-SAR-bisPSMA with enzalutamide. This protocol amendment has now been approved at many of the participating trial sites, and the changes are expected to further enhance the already positive results of

Cu-SAR-bisPSMA与恩杂鲁胺。这一方案修正案现已在许多参与试验的地点获得批准，这些变更预计将进一步提升已经取得的积极结果。

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Cu-SAR-bisPSMA observed in the SECuRE trial to date. This strategy focuses on the commercialisation of the product firstly in the largest market for prostate cancer therapies in mCRPC, with pre-chemotherapy being 3 times larger than the post-chemotherapy setting, and creates opportunities for the use of .

在SECuRE试验中观察到的Cu-SAR-bisPSMA。该策略专注于首先在最大的前列腺癌治疗市场mCRPC中将产品商业化，化疗前市场是化疗后市场的三倍，并创造了使用的机遇。

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Cu-SAR-bisPSMA with a range of ARPIs in future clinical development. Addressing the radiopharmaceuticals supply issues with current treatments in such a large indication requires a streamlined approach for which Clarity’s

Cu-SAR-bisPSMA 与一系列 ARPI 联合应用，未来临床开发前景广阔。针对当前治疗中如此大适应症的放射性药物供应问题，需要一种简化的策略，而这正是 Clarity 的

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Cu/

铜/

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Cu platform is well and uniquely suited.

铜平台非常适合且独特。

Clarity’s Executive Chairperson, Dr Alan Taylor, commented,

克拉利蒂的执行主席艾伦·泰勒博士评论道，

“Receiving 3 FTDs for the one molecule, SAR-bisPSMA, within the last 6 months is an incredible achievement for Clarity, highlighting how impressive our science and development are, the significance of the diagnostic and therapeutic data so far, and the high unmet need for better therapies and diagnostics in prostate cancer..

“在过去的六个月中，Clarity 获得了针对单一分子 SAR-bisPSMA 的三项快速通道资格认定，这是 Clarity 的一项非凡成就，突显了我们的科学和开发实力、迄今为止诊断和治疗数据的重要性，以及在前列腺癌领域对更好的治疗和诊断方法的高度未满足需求。”

“The dual-targeted bisPSMA molecule was developed at the benchtop of Australian science with the intent of overcoming the shortfalls of the current generation of PSMA-targeting products. It was optimised with two PSMA ligands, which increases not only the amount of product in the lesions, but also how long the product is retained in the lesions over time, making it an ideal candidate for both diagnosis and therapy.

“双靶向bisPSMA分子是在澳大利亚科学实验室中开发的，旨在克服当前一代PSMA靶向产品的不足。它通过优化两个PSMA配体，不仅增加了病灶中产物的量，还延长了产物在病灶中的滞留时间，使其成为诊断和治疗的理想候选者。

The clinical data in both diagnostic and therapeutic indications that we are generating is remarkable, confirming the results that we initially saw in preclinical development. The granting of FTDs by the US FDA for 3 distinct indications in prostate cancer that we are aiming to address with this product is testament to the incredible work of our team and collaborators.

我们在诊断和治疗适应症方面生成的临床数据非常显著，证实了我们在临床前开发阶段最初看到的结果。美国FDA授予我们这款产品针对前列腺癌三种不同适应症的快速通道资格（FTD），这证明了我们的团队和合作伙伴所做的出色工作。

This latest FTD will allow us flexibility to develop .

这个最新的FTD将使我们能够灵活开发。

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Cu-SAR-bisPSMA in both pre- and post-chemotherapy patients in the mCRPC setting, with initial focus on the largest market segment. The SECuRE study will also provide invaluable information on the potential of

在mCRPC环境中，无论是化疗前还是化疗后的患者都使用Cu-SAR-bisPSMA，最初的重点是最大的市场细分。SECuRE研究还将提供关于其潜力的宝贵信息。

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Cu-SAR-bisPSMA to be combined with enzalutamide and other ARPIs in future, creating opportunities for the broader use of

Cu-SAR-bisPSMA未来将与恩杂鲁胺和其他ARPI联合使用，为更广泛的应用创造机会

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Cu-SAR-bisPSMA in those patients with such high unmet medical need.

Cu-SAR-bisPSMA 在那些具有如此高未满足医疗需求的患者中。

“These designations will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become best-in-class therapy and diagnostic agents, and our team and collaborators are committed to making this our priority in order to achieve our ultimate goal of improving treatment outcomes for people with cancer.”.

“这些指定将使我们能够与FDA密切合作，促进开发进程，并加速可能成为同类最佳的治疗和诊断剂的批准，我们的团队和合作伙伴致力于将此作为我们的优先事项，以实现我们改善癌症患者治疗效果的最终目标。”

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body.

SAR-bisPSMA 的名称来源于“bis”一词，反映了将两个靶向 PSMA 的分子连接到 Clarity 专有的 sarcophagine（SAR）技术上的新方法，该技术能够将铜同位素安全地固定在一个笼状结构（称为螯合剂）内。与其他市售螯合剂不同，SAR 技术可防止铜泄漏到体内。

SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or .

SAR-bisPSMA 是一种靶向铜治疗诊断剂 (TCT)，可与铜-64 (Cu-64) 的同位素一起使用。

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Cu) for imaging and copper-67 (Cu-67 or

用于成像的铜-67（Cu-67 或

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Cu) for therapy.

铜）用于治疗。

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Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of

Cu-SAR-bisPSMA 是一种未注册的产品。其安全性和有效性

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Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.

Cu-SAR-bisPSMA 尚未经过美国 FDA 或治疗用品管理局 (TGA) 等卫生当局的评估。无法保证该产品会实现商业供应。

SECuRE (NCT04868604)

安全的 (NCT04868604)

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is a Phase I/IIa theranostic trial for identification and treatment of an advanced form of prostate cancer, mCRPC. It is a multi-centre, single arm, dose escalation study with a cohort expansion. The aim of this trial is to determine the safety and tolerability of both

是一个用于识别和治疗晚期前列腺癌（mCRPC）的I/IIa期治疗诊断试验。它是一项多中心、单臂、剂量递增研究，并包含队列扩展。该试验的目的是确定两者的安全性和耐受性。

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Cu-SAR-bisPSMA and

Cu-SAR-bisPSMA 和

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Cu-SAR-bisPSMA, as well as the efficacy of

Cu-SAR-bisPSMA，以及其疗效

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Cu-SAR-bisPSMA as a therapy. A recent protocol amendment has increased the number of participants in the cohort expansion phase from 14 to 24, and a subset of participants will receive the combination of

Cu-SAR-bisPSMA 作为一种治疗手段。最近的方案修正案已将在队列扩展阶段的参与者人数从14人增加到24人，其中一部分参与者将接受联合治疗。

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Cu-SAR-bisPSMA with enzalutamide.

Cu-SAR-bisPSMA 与恩杂鲁胺。

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide

前列腺癌是全球男性中诊断出的第二大常见癌症，也是全球男性癌症死亡的第五大原因。

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. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the U.S. and around 35,770 deaths from the disease

前列腺癌是美国男性癌症死亡的第二大原因。美国癌症研究所估计，到2025年，美国将有大约313,780例新发前列腺癌病例，约35,770人死于该疾病。

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。

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers in children and adults.

Clarity是一家处于临床阶段的放射性药物公司，专注于严重疾病的治疗。该公司是创新放射性药物的领导者，基于其SAR技术平台开发针对儿童和成人癌症的靶向铜治疗诊断学。

Source: Clarity Pharmaceuticals

来源：Clarity Pharmaceuticals

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