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Avidity Biosciences宣布新的AOC 1001阳性数据,证明1型肌营养不良患者多个额外功能终点的改善以及良好的长期安全性和耐受性

Avidity Biosciences Announces New Positive AOC 1001 Data Demonstrating Improvement in Multiple Additional Functional Endpoints and Favorable Long-term Safety and Tolerability in People with Myotonic Dystrophy Type 1

PR Newswire 等信源发布 2023-10-07 19:30

可切换为仅中文


New AOC 1001 data demonstrate improvement in additional functional measures including hand grip, muscle strength and patient reported outcomes, augmenting previously reported positive data showing improvements in myotonia, muscle strength and mobility

新的AOC 1001数据显示,在其他功能测量方面有所改善,包括握力、肌肉力量和病人报告的结果,增加了先前报告的显示肌强直、肌肉力量和活动能力改善的积极数据

New long-term safety data of AOC 1001 continue to demonstrate favorable safety and tolerability with over 200 infusions totaling 46.2 patient-years of exposure

AOC 1001的新的长期安全性数据继续显示有利的安全性和耐受性,超过200次输注总共46.2患者年的暴露

Data from 12 participants dose-escalated from 2 mg/kg to 4 mg/kg of AOC 1001 as part of the easement of the partial clinical hold showed no neurological events and no MRI changes following dosing

来自12名参与者的数据剂量从2mg/kg增加到4mg/kg的AOC 1001作为部分临床保持的缓解的一部分显示没有神经事件并且在给药后没有MRI变化

Company plans to share AOC 1001 data from MARINA-OLE study in first half of 2024 and is finalizing Phase 3 study design and global regulatory path for AOC 1001

公司计划于2024年上半年分享MARINA-OLE研究的AOC 1001数据,并最终确定AOC 1001的第3阶段研究设计和全球监管路径

SAN DIEGO, Oct. 7, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced new positive AOC 1001 data demonstrating improvement in multiple additional functional endpoints and favorable long-term safety and tolerability in people living with myotonic dystrophy type 1 (DM1).

圣地亚哥,2023年10月7日/PRNewswire/-Avidity Biosciences,Inc。(纳斯达克股票代码:RNA),一家生物制药公司,致力于提供一类新的RNA治疗药物,称为抗体-寡核苷酸结合物(AOCs)™), 今天宣布了新的AOC 1001阳性数据,证明了1型肌强直性营养不良(DM1)患者多个额外功能终点的改善以及有利的长期安全性和耐受性。

AOC 1001, Avidity's lead clinical program utilizing its AOC platform, is designed to address the root cause of DM1, an underrecognized, progressive and often fatal neuromuscular disease with no approved therapies. The AOC 1001 data from the Phase 1/2 MARINA® trial and MARINA open-label extension (MARINA-OLE™) study will be highlighted in an oral presentation at the 28th Annual Congress of the World Muscle Society (WMS) in Charleston, South Carolina and can be found on Avidity's website on the Publications page..

AOC 1001是Avidity利用其AOC平台的领先临床计划,旨在解决DM1的根本原因,DM1是一种未被认可的,进行性的,通常是致命的神经肌肉疾病,未经批准的治疗方法。1001数据来自1/2阶段MARINA试验和MARINA开放标签扩展(MARINA-OLE™) 研究将在南卡罗来纳州查尔斯顿举行的世界肌肉学会(WMS)第28届年会上的口头报告中突出显示,并可在Avidity的网站上的出版物页面上找到。。

'The new AOC 1001 data presented today demonstrating improvements in muscle strength and patient reported outcomes add to the previously reported positive topline data showing improvements in myotonia and mobility. The AOC 1001 data continues to be quite remarkable with consistent improvements across multiple functional endpoints,' said Nicholas E.

'今天提供的新的AOC 1001数据显示肌肉力量和患者报告结果的改善增加了先前报道的显示肌强直和活动性改善的正面数据。尼古拉斯说,AOC 1001数据在多个功能端点的一致改进下仍然非常显着。

Johnson, M.D., M.Sci., FAAN, associate professor and vice chair of research in the Department of Neurology at Virginia Commonwealth University, lead investigator of the MARINA trial and study presenter. 'The AOC 1001 functional data coupled with the long-term favorable tolerability and safety data provide us with hope that AOC 1001 has the potential to help patients with DM1, who are in desperate need of treatments.'.

Johnson,M.D.,M.Sci。,FAAN,弗吉尼亚联邦大学神经病学系副教授兼副主席,MARINA试验和研究主持人首席研究员AOC 1001功能数据加上长期有利的耐受性和安全性数据为我们提供了希望,AOC 1001有可能帮助迫切需要治疗的DM1患者。

The new AOC 1001 data demonstrate improvement in additional functional measures including hand grip, muscle strength and patient reported outcomes, augmenting previously reported positive data showing improvements in myotonia, muscle strength and mobility. With new long-term safety data from over 200 infusions totaling 46.2 patient-years of exposure, AOC 1001 continues to demonstrate favorable safety and tolerability with most adverse events (AEs) mild to moderate..

新的AOC 1001数据显示了其他功能测量方面的改进,包括握力,肌肉力量和患者报告的结果,增加了先前报道的显示肌强直,肌肉力量和活动性改善的阳性数据。随着来自200多次输注的新的长期安全性数据总计46.2患者-年的暴露,AOC 1001继续表现出有利的安全性和耐受性,大多数不良事件(AE)轻度至中度。。

'Data from MARINA and MARINA-OLE reinforce our belief in the potential of AOC 1001 to become an effective treatment option for people living with DM1, a devastating rare disease for which there are no treatment options available. With this robust data package, we are finalizing the Phase 3 study design and global regulatory path for AOC 1001 and look forward to sharing a first look at efficacy data from the MARINA-OLE study in the first half of 2024,' said Sarah Boyce, president and chief executive officer at Avidity.

来自MARINA和MARINA-OLE的数据强化了我们对AOC 1001成为DM1患者的有效治疗选择的潜力的信念,DM1是一种毁灭性的罕见疾病,目前尚无治疗选择。有了这个强大的数据包,我们正在最终确定AOC 1001的3期研究设计和全球监管路径,并期待在2024年上半年分享MARINA-OLE研究的第一眼功效数据,“Sarah Boyce说,Avidity的总裁兼首席执行官。

'In addition to our DM1 program, we continue to advance our DMD and FSHD clinical development programs and plan to report data from all three of our programs by mid-2024 while continuing to expand our discovery and development pipeline.'.

“除了我们的DM1计划外,我们还继续推进DMD和FSHD临床开发计划,并计划在2024年中期之前报告我们所有三个计划的数据,同时继续扩大我们的发现和开发流程。”。

In May 2023, the U.S. Food and Drug Administration (FDA) eased the partial clinical hold on AOC 1001, allowing Avidity to double the number of participants in the MARINA-OLE study receiving 4 mg/kg of AOC 1001 from 12 to 24 participants. Data from the 12 participants dose-escalated from 2 mg/kg to 4 mg/kg of AOC 1001 as part of the easement of the partial clinical hold showed no neurological events and no MRI changes following dosing.

2023年5月,美国食品和药物管理局(FDA)缓解了AOC 1001的部分临床保留,使亲合力使接受4 mg/kg AOC 1001的MARINA-OLE研究的参与者人数从12人增加到24人。来自12名参与者的数据剂量从2mg/kg升至4mg/kg的AOC 1001,作为部分临床保留的缓解的一部分,显示在给药后没有神经事件和MRI变化。

The company continues to work as quickly as possible to resolve the partial clinical hold.  .

公司继续尽快工作,以解决部分临床问题。 .

Data presented at World Muscle Society (WMS)The Phase 1/2 MARINA trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of single and multiple ascending doses of AOC 1001 administered intravenously in adults with DM1. Data were assessed from a 3:1 randomized study with 38 participants who were administered one dose of 1 mg/kg of AOC 1001, three doses of either 2 mg/kg of AOC 1001 or 4 mg/kg of AOC 1001 (reflected as siRNA dose), or placebo.

世界肌肉学会(WMS)提供的数据1/2期MARINA试验是一项随机,双盲,安慰剂对照研究,旨在评估成人静脉注射单次和多次递增剂量AOC 1001的安全性和耐受性。与DM1。数据来自3:1随机研究,38名参与者给予一剂1 mg/kg AOC 1001,3剂2 mg/kg AOC 1001或4 mg/kg AOC 1001(反映为siRNA剂量)或安慰剂。

The endpoints used in MARINA measure important aspects of the disease and correspond to those utilized in the ongoing END-DM1 natural history study. All 37 participants that completed the MARINA trial remain on AOC 1001 in the MARINA-OLE trial. Safety and tolerability data of AOC 1001 include data from MARINA and MARINA-OLE.

MARINA中使用的终点测量疾病的重要方面,并与正在进行的END-DM1自然史研究中使用的终点相对应。完成MARINA试验的所有37名参与者在MARINA-OLE试验中仍留在AOC 1001上。AOC 1001的安全性和耐受性数据包括来自MARINA和MARINA-OLE的数据。

There were 10 participants treated with placebo in MARINA that were newly treated with AOC 1001 in MARINA-OLE. .

在MARINA中有10名参与者接受安慰剂治疗,他们在MARINA-OLE中新接受了AOC 1001治疗。 .

New AOC 1001 data demonstrate improvement in additional functional measures augmenting previously reported positive data that demonstrated improvements in functional assessments of myotonia (video hand opening time, or vHOT), strength (Quantitative Muscle Testing total score, or QMT) and mobility (10-meter walk run test, or 10mWRT and the Timed Up and Go test, or TUG)..

新的AOC 1001数据显示其他功能测量方面的改进,增加了先前报道的阳性数据,这些数据显示肌强直功能评估(视频手打开时间或vHOT),力量(定量肌肉测试总分或QMT)和移动性(10米步行运行测试,或10mWRT和Timed Up and Go测试,或TUG)。。

New positive AOC 1001 data presented at WMS include:

WMS提供的新的积极AOC 1001数据包括:

Multiple additional measures of strength:

多种额外的力量测量:

Hand grip

握力

Manual Muscle Testing (MMT) composite score

手动肌肉测试(MMT)综合评分

Both upper and lower QMT composites

上下QMT复合材料

DM1-Activ, a patient reported outcome (PRO) that measures activities of daily living (e.g., taking a shower, visiting family or friends, and walking up stairs).

DM1 Activ,患者报告的结果(PRO),测量日常生活活动(例如洗澡,拜访家人或朋友,上楼梯)。

New favorable long-term AOC 1001 safety and tolerability data include data from MARINA-OLE with over 200 infusions totaling 46.2 patient-years of exposure.

新的有利的长期AOC 1001安全性和耐受性数据包括来自MARINA-OLE的数据,超过200次输注,总共46.2患者年暴露。

The most common AEs in the MARINA-OLE were procedural pain (22%), pain in extremity (such as arm, leg or foot pain/soreness) and headache (both 16%).

MARINA-OLE中最常见的AE是手术疼痛(22%),肢体疼痛(如手臂,腿部或脚部疼痛/酸痛)和头痛(均为16%)。

There was one resolved adverse event of mild increase in liver enzymes.

有一个解决了肝酶轻度增加的不良事件。

There have been no reported AEs of anemia in the MARINA-OLE. In the MARINA clinical program, anemia has been asymptomatic except for one participant who did not require treatment.

在MARINA-OLE中没有报道贫血的AE。在MARINA临床计划中,除了一名不需要治疗的参与者外,贫血一直没有症状。

There have been no discontinuations in the MARINA-OLE study.

MARINA-OLE研究没有中断。

In addition to evaluating AOC 1001 in the MARINA-OLE trial in people living with DM1, Avidity is also advancing AOC 1044 in the Phase 1/2 EXPLORE44™ trial in people living with DMD44 and plans to report data from healthy volunteers in the EXPLORE44 trial in the fourth quarter of 2023. In addition, the company is evaluating AOC 1020 in the Phase 1/2 FORTITUDE™ trial in people living with FSHD.

除了在DM1患者的MARINA-OLE试验中评估AOC 1001外,Avidity还在1/2期探索中推进AOC 1044 44™ 在DMD44患者中进行试验,并计划在2023年第四季度的EXPLORE44试验中报告健康志愿者的数据。此外,该公司正在评估AOC 1020的1/2阶段强度™ 在FSHD患者中进行试验。

Data from a preliminary assessment in approximately half of the participants in the FORTITUDE trial is planned for the first half of 2024..

FORTITUDE试验中大约一半参与者的初步评估数据计划于2024年上半年进行。。

About the Phase 1/2 MARINA® Trial The MARINA® trial is a randomized, double-blind, placebo-controlled, Phase 1/2 clinical trial that enrolled 38 adults with DM1. The primary objective of this study was to evaluate the safety and tolerability of single and multiple ascending doses of AOC 1001 administered intravenously.

关于1/2MRINA®试验,MARINA®试验是一项随机,双盲,安慰剂对照的1/2期临床试验,招募了38名DM1成人。本研究的主要目的是评估静脉注射单次和多次递增剂量的AOC 1001的安全性和耐受性。

The MARINA trial assessed the activity of AOC 1001 across key biomarkers, including spliceopathy, an important biomarker for DM1, and knockdown of DMPK mRNA. Though the Phase 1/2 trial was not powered to assess functional benefit, it explored the clinical activity of AOC 1001 in multiple measures of muscle function including myotonia, muscle strength, measures of mobility as well as patient reported outcomes and quality of life measures.

MARINA试验评估了AOC 1001在关键生物标志物中的活性,包括剪接病,DM1的重要生物标志物和DMPK mRNA的敲低。尽管1/2期临床试验无法评估功能获益,但它探讨了AOC 1001在多种肌肉功能测量中的临床活性,包括肌强直,肌肉力量,活动度测量以及患者报告的结果和生活质量措施。

Patients had the option to enroll in MARINA-OLE, an open-label extension study, at the end of the post-treatment period. For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT05027269..

在治疗后期结束时,患者可以选择参加开放标签扩展研究MARINA-OLE。有关此研究的更多信息,请单击此处或访问http://www.clinicaltrials.gov并搜索NCT05027269。。

About the Phase 2 MARINA-OLE™ Study MARINA-OLE™ is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of AOC 1001 in participants with DM1 who were previously enrolled in the MARINA Phase 1/2 trial. This trial will continue to evaluate the safety, tolerability, PK, PD, and efficacy of AOC 1001 in participants enrolled in the randomized, placebo-controlled, Phase 1/2 MARINA clinical trial.

关于第二阶段MARINA-OLE™研究MARINA-OLE™是一项开放标签的多中心试验,旨在评估AOC 1001在先前参加MARINA 1/2期试验的DM1参与者中的长期安全性和耐受性。该试验将继续评估AOC 1001在参加随机,安慰剂对照,1/2期MARINA临床试验的参与者中的安全性,耐受性,PK,PD和功效。

Participants enrolled in the MARINA-OLE study receive quarterly doses of AOC 1001 regardless of whether they received active treatment or placebo in the MARINA study. The total duration of active treatment with AOC 1001 in the MARINA-OLE study is approximately 24 months. Once patients have completed active treatment, there will be a nine-month safety follow-up period.

参加MARINA-OLE研究的参与者每季度接受一次AOC 1001剂量,无论他们是否在MARINA研究中接受积极治疗或安慰剂。在MARINA-OLE研究中用AOC 1001积极治疗的总持续时间约为24个月。一旦患者完成积极治疗,将有9个月的安全随访期。

Avidity may extend active treatment beyond 24 months at a future timepoint. For more information on this study click here or visit http://www.clinicaltrials.gov and search for NCT05479981..

在未来的时间点,Avidity可能会延长超过24个月的积极治疗。有关此研究的更多信息,请单击此处或访问http://www.clinicaltrials.gov并搜索NCT05479981。。

About AOC 1001AOC 1001, Avidity's lead product candidate utilizing its AOC platform, is designed to address the root cause of DM1 by reducing levels of a disease-related mRNA called DMPK. AOC 1001 consists of a proprietary monoclonal antibody that binds to the transferrin receptor 1 (TfR1) conjugated with a siRNA targeting DMPK mRNA.

关于AOC 1001AOC 1001,Avidity利用其AOC平台的主要候选产品,旨在通过降低称为DMPK的疾病相关mRNA的水平来解决DM1的根本原因。AOC 1001由与靶向DMPK mRNA的siRNA缀合的转铁蛋白受体1(TfR1)结合的专有单克隆抗体组成。

In preclinical studies, AOC 1001 successfully delivered siRNAs to muscle cells, resulting in durable, dose-dependent reductions of DMPK RNA across a broad range of muscles including skeletal, cardiac, and smooth muscles. AOC 1001 is currently in Phase 1/2 development with the completed MARINA® trial and the ongoing MARINA-OLE™ trial in adults with DM1.

在临床前研究中,AOC 1001成功地将siRNA递送至肌肉细胞,导致DMPK RNA在包括骨骼肌,心肌和平滑肌在内的广泛肌肉中持久,剂量依赖性降低。Aoc1001目前正处于1/2阶段的开发阶段,完成了MARINA试验和正在进行的MARINA-OLE™在DM1成人中进行试验。

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted Orphan Designation for AOC 1001 and the FDA has granted AOC 1001 Fast Track Designation..

美国食品和药物管理局(FDA)和欧洲药品管理局(EMA)已授予AOC 1001孤儿称号,FDA已授予AOC 1001快速通道称号。。

About Myotonic Dystrophy Type 1Myotonic dystrophy type 1 (DM1) is an underrecognized, progressive and often fatal disease caused by a triplet-repeat in the DMPK gene, resulting in a toxic gain of function mRNA. The disease is highly variable with respect to severity, presentation and age of onset, however all forms of DM1 are associated with high levels of disease burden and may cause premature mortality.

关于1型强直性肌营养不良症1型强直性肌营养不良症(DM1)是由DMPK基因中的三联体重复引起的未被充分认识,进行性且通常致命的疾病,导致毒性功能获得性mRNA。该疾病在严重程度,表现和发病年龄方面变化很大,但是所有形式的DM1都与高水平的疾病负担相关,并可能导致过早死亡。

DM1 primarily affects skeletal and cardiac muscle, however patients can suffer from a constellation of manifestations including myotonia and muscle weakness, respiratory problems, fatigue, hypersomnia, cardiac abnormalities, severe gastrointestinal complications, and cognitive and behavioral impairment.

DM1主要影响骨骼肌和心肌,但是患者可能会遭受一系列表现,包括肌强直和肌肉无力,呼吸系统疾病,疲劳,嗜睡,心脏异常,严重的胃肠道并发症以及认知和行为障碍。

Currently, there are no approved treatments for people living with DM1..

目前,还没有批准的治疗DM1患者的方法。。

About AvidityAvidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies.

关于AvidityAvidity Biosciences,Inc。的使命是通过提供一类新的RNA疗法-抗体-寡核苷酸偶联物(AOCs)来深刻改善人们的生活™). Avidity正在用其专有的AOC彻底改变RNA领域,AOC旨在将单克隆抗体的特异性与寡核苷酸疗法的精确度相结合,以解决以前无法与现有RNA疗法接触的靶标和疾病。

Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

利用其专有的AOC平台,Avidity展示了首次成功地将RNA靶向递送到肌肉中,并且正在领导该领域的三种罕见肌肉疾病的临床开发计划:1型强直性肌营养不良症(DM1),Duchenne肌营养不良症(DMD)和面肩胛肱肌营养不良症(FSHD)。

Avidity is broadening the reach of AOCs with its advancing and expanding pipeline including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and X (formerly Twitter)..

Avidity正在通过内部发现工作和关键合作伙伴关系,扩大和扩展AOC的范围,包括心脏病学和免疫学计划。Avidity总部设在加利福尼亚州圣地亚哥。有关我们的AOC平台,临床开发渠道和人员的更多信息,请访问www.aviditybiosciences.com并在LinkedIn和X(以前称为Twitter)上与我们联系。。

Forward-Looking StatementsAvidity cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the characterization of safety, tolerability and functional data associated with AOC 1001; the impact of such data on the advancement of AOC 1001; expectations related to the MARINA-OLE study and AOC 1001; the anticipated timing of release of data from the MARINA-OLE™, EXPLORE44™ and FORTITUDE™ trials; plans for a Phase 3 study and global regulatory path for AOC 1001; plans for the progression of clinical programs for AOC 1001, AOC 1044 and AOC 1020 and the timing thereof; the potential of Avidity's product candidates to treat rare diseases and Avidity's efforts to bring them to people suffering from applicable diseases; the potential of AOCs to target a range of different cells and tissues beyond the liver, and to treat cardiac and immunological diseases; and Avidity's plans to expand its AOC platform and to invest in its pipeline programs..

前瞻性声明Savidity警告读者,本新闻稿中包含的关于非历史事实事项的陈述是前瞻性陈述。这些陈述基于公司目前的信念和期望。这些前瞻性陈述包括但不限于以下陈述:与AOC 1001相关的安全性,耐受性和功能数据的表征;这些数据对AOC 1001进展的影响;与MARINA-OLE研究和AOC 1001有关的期望;从MARINA-OLE发布数据的预期时间™, 探索44™ 和坚韧™ 审判;AOC 1001的3期研究和全球监管路径计划;AOC 1001,AOC 1044和AOC 1020临床计划进展计划及其时间安排;Avidity的候选产品有可能治疗罕见疾病,Avidity努力将其带到患有适用疾病的人身上;AOC针对肝脏以外的一系列不同细胞和组织以及治疗心脏和免疫疾病的潜力;Avidity计划扩展其AOC平台并投资其管道计划。。

The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Avidity's business, including, without limitation: Avidity may not be able to resolve the partial clinical hold related to the serious adverse event which occurred in the Phase 1/2 MARINA trial, which may result in delays in the clinical development of AOC 1001; additional participant data related to AOC 1001 that continues to become available may be inconsistent with the data produced as of the date hereof, and further analysis of existing data and analysis of new data may lead to conclusions different from those established as of the date hereof; unexpected adverse side effects to, or inadequate efficacy of, Avidity's product candidates that may delay or limit their development, regulatory approval and/or commercialization, or may result in additional clinical holds which may not be timely lifted, recalls or product liability claims; Avidity is early in its development efforts; Avidity's approach to the discovery and development of product candidates based on its AOC platform is unproven, and the company does not know whether it will be able to develop any products of commercial value; potential delays in the commencement, enrollment, data readouts and completion of preclinical studies or clinical trials; the success of its preclinical studies and clinical trials for the company's product candidates; Avidity's dependence on third parties in connection with preclinical and clinical testing and product manufacturing; Avidity may not realize the expected benefits of its collaborations; regulatory developments in the Uni.

包含前瞻性陈述不应被视为任何这些计划将实现的狂热表现。由于Avidity业务固有的风险和不确定性,实际结果可能与本新闻稿中提出的结果不同,包括但不限于:Avidity可能无法解决与阶段发生的严重不良事件相关的部分临床保留1/2 MARINA试验,可能导致AOC 1001临床开发延迟;继续可用的与AOC 1001相关的其他参与者数据可能与截至本协议签署之日生成的数据不一致,对现有数据的进一步分析和新数据的分析可能会得出与截至本协议签署之日确定的结论不同的结论;可能延迟或限制其发展,监管批准和/或商业化,或可能导致可能无法及时解除,召回或产品责任索赔的额外临床持有的Avidity产品候选人的意外不良副作用或效力不足;亲和力是其发展努力的早期阶段;Avidity基于其AOC平台发现和开发候选产品的方法尚未得到证实,公司不知道它是否能够开发任何具有商业价值的产品;临床前研究或临床试验的开始,登记,数据读数和完成的潜在延误;公司产品候选人的临床前研究和临床试验取得成功;Avidity在临床前和临床测试以及产品制造方面依赖第三方;亲和力可能无法实现其合作的预期收益;大学的监管发展。

Investor Contact:Geoffrey Grande, CFA(619) 837-5014[email protected]

投资者联系人:Geoffrey Grande,CFA(619)837-5014[电子邮件保护]

Media Contact:Navjot Rai(619) 837-5016[email protected]

媒体联系人:Navjot Rai(619)837-5016[电子邮件保护]

SOURCE Avidity Biosciences, Inc.

来源Avidity Biosciences,Inc。