Pantothenate Kinase-Associated Neurodegeneration

– Project ‘NADER’ is intended to span multiple phases, starting from mapping rare diseases in the UAE and wider region through innovative risk assessment algorithms, and moving towards clinical trials with transformative medicines Burjeel Holdings, one of the largest healthcare providers in the MENA region, and BridgeBio Pharma, Inc., a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, have announced a new project to revolutionize the field of early diagnosis and treatment of rare diseases or disorders in the UAE and the region. The two entities signed a preliminary, non-binding Collaboration Agreement establishing a mutual intention to work together on project ‘NADER’ (Needs Assessment and Therapeutics Development for Rare Diseases – ‘nader’ meaning ‘rare’ in Arabic). Genetic in origin, these often life-threatening or chronically debilitating diseases affect a small percentage of the population and are present throughout the person's entire life, even if symptoms do not immediately appear. The partnership will launch operations in Abu Dhabi to conduct clinical trials and research, leveraging the Emirate’s advanced infrastructure for innovation and life science. Project ‘NADER’ aims to revolutionize the field of early diagnosis and treatment in order to potentially improve patient outcomes. The entities intend to collaborate on identifying patients with several rare diseases, including achondroplasia, hypochondroplasia, FGFR-driven craniosynostoses, autosomal dominant hypocalcemia type 1, limb girdle muscular dystrophy type 2i, congenital adrenal hyperplasia, Canavan disease, propionic acidemia, methylmalonic acidemia, pantothenate kinase-associated neurodegeneration, and others as mutually agreed. Even though these rare diseases affect a small percentage of the population and can present with nonspecific signs and symptoms, they are often misdiagnosed or only diagnosed later in the disease course after severe complications manifest. Accurate and early diagnosis are crucial to starting intervention promptly and avoiding disease progression. The project will also allow identification of patients who have already been diagnosed but do not currently have access to cutting edge therapies or clinical trial options. In the first phase of project ‘NADER’, the two entities intend to utilize innovative risk assessment algorithms that will be deployed through the healthcare provider’s secure internal data to identify patients at risk for specific rare diseases. Expectations for future phases of the project include analyses of vast amounts of data to identify patterns and markers associated with the diseases and generate personalized risk scores for patients, followed by genetic testing to confirm the diagnosis of identified potential patients. The project also aims to run awareness campaigns and education activities about such rare diseases, to further support the mapping activity and encourage local collaborations from other healthcare providers. Burjeel Holdings will deploy the project across its widespread hospitals and medical centers across the UAE as part of routine diagnostic care, with plans to expand the project through its growing healthcare infrastructure in the region. Local partnerships will also be sought to facilitate wider implementation. Speaking on the partnership’s potential to transform the way rare diseases are identified, Mr. John Sunil, CEO of Burjeel Holdings, said, “Project ‘NADER’ marks a significant milestone in our commitment to delivering the best possible care to our patients. It brings together Burjeel’s expertise in healthcare delivery and outreach and BridgeBio’s vast expertise in delivering breakthrough therapies for rare diseases. By combining our strengths, we seek to address the challenges faced in identification of rare diseases, which often go undiagnosed until symptoms become severe. The project will enable early interventions whether in the form of established treatments or novel therapies.” Commenting on the project launch, Dr. Asma Ibrahim Al Mannaei, Executive Director of the Research, and Innovation Center at the Department of Health – Abu Dhabi (DoH), said: “As part of our ongoing efforts to advance early diagnosis and treatment, the Department of Health – Abu Dhabi is proud to witness yet another leading partnership aimed at propelling transformative medicine to safeguard the health and well-being of community members. Reinforcing Abu Dhabi’s position as a leading destination for life science and innovation, we remain committed to empowering healthcare providers in the Emirate with the means to lead research studies and conduct clinical trials to map out a path towards discovery and breakthrough healthcare in the Emirate and beyond. Similar initiatives translate the Department’s vision in securing health for all while accelerating healthcare outcomes for the benefit of the global community.” The first phase will aim to set the roadmap to providing novel treatment options for identified patients through clinical trials. Dr. Khaled Musallam, Group Chief Research Officer of Burjeel Holdings and project lead said, “Many rare diseases are highly clustered in our region due to our unique genetic pool. These diseases are often ‘lost in the system’ or have very limited treatment options. Our ultimate goal from project ‘NADER’ is to link patients to evolving treatment options through clinical trials of small molecules and gene therapies. The first step to bringing such innovative solutions to our region is to identify disease burden and patients’ unmet needs.” “Building on our already established foundation of genetic disease patient care, we hope that BridgeBio can help bring more patients access to novel treatments, clinical trials, and capabilities alongside a strong partner like Burjeel, and so we are grateful to be working with them to expand our efforts in the MENA region. The BridgeBio vision is to serve patients around the world, and this is an important step in that direction,” said Neil Kumar, Ph.D., BridgeBio founder and CEO. As the collaboration unfolds, both Burjeel Holdings and BridgeBio anticipate significant progress in the field of rare diseases in the region. The project could also provide patients in the region with increased access to BridgeBio’s state-of-the-art pharmacologic and gene therapies that are currently in development. About Burjeel Holdings Founded in 2007, Burjeel Holdings is one of the leading private healthcare services providers in the MENA region. With a network of 62 assets, including 16 hospitals and 24 medical centers, as well as pharmacies and other allied services, the group provides the highest standard of patient care in the region. Burjeel Medical City, the flagship facility of Burjeel Holdings, is a 400-bed multi-specialty hospital and quaternary care center located in Abu Dhabi, UAE. It offers high-quality specialized treatment and complex care in over 40 adult and pediatric specialties, aided by state-of-the-art medical technology and an international team of experts. Find more information at www.burjeelmedicalcity.com, www.burjeelholdings.com. About BridgeBio Pharma, Inc. BridgeBio Pharma Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers, and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter. The content above comes from the network. if any infringement, please contact us to modify.

▎药明康德内容团队编辑本期看点Viridian Therapeutics公布其甲状腺眼病（TED）新药VRDN-001的1/2期临床试验中10 mg/kg队列的数据，结果亮眼。Tessa Therapeutics在研CAR-T疗法联合PD-1抑制剂治疗CD30阳性经典霍奇金淋巴瘤的1b期临床试验完成首例患者给药。Ventyx Biosciences别构TYK2抑制剂VTX958的1期数据积极，支持进入2期试验。药明康德内容团队整理VRDN-001：1/2期临床试验10 mg/kg队列数据公布VRDN-001是一种用于治疗甲状腺眼病的抗IGF-1R单克隆抗体，可以通过亚纳摩尔级别的亲和力结合和阻断IGF-1R信号通路。这种作用机制已在TED的临床实践中得到了验证。此次公布数据的临床试验是一项双盲、安慰剂对照的1/2期试验， 在10 mg/kg队列中，83%的患者相比于基线时眼球突出减少≥2 mm（平均减少2.4 mm），且起效迅速，中位响应时间为3周；83%的患者的临床活动性评分（CAS）达到0或1（意味着治疗效果达到或接近最高水平），相比于基线平均减少4.3个点；75%的患者的复视症状完全消退。安全性方面，VRDN-001显示出了良好的安全性和耐受性，没有报告严重的不良事件，也没有患者停药、出现高血糖或输液反应。该公司表示，更多剂量队列的数据将在2022年第四季度进行收集或公布。TT11：联合PD-1抑制剂的1b期临床试验完成首例患者给药TT11是一款靶向CD30的在研自体CAR-T疗法。近日，Tessa公司宣布，TT11联合nivolumab作为潜在的二线疗法治疗复发/难治性CD30阳性经典霍奇金淋巴瘤（cHL）的1b期开放标签试验已完成了对首例患者的给药。目前，TT11作为复发/难治性cHL的潜在治疗方法的临床研究包括一项单一疗法（2期）和一项联合疗法（1b期）。正在进行的2期CHARIOT试验结果显示，TT11在14例可评估的复发或难治性cHL的患者中具有良好的安全性和有希望的疗效，完全缓解（CR）率为57.1%，总缓解率（ORR）为71.4%。VTX958：1期临床试验数据公布VTX958是一款口服、具选择性的别构TYK2抑制剂。TYK2是一种通过介导IFNα、IL-12与IL-23信息来调节先天与适应性免疫的激酶。这些靶点已在临床上证实与治疗许多免疫系统引起的疾病有关，包含银屑病、银屑病关节炎、克罗恩病、溃疡性结肠炎与狼疮。在不影响其他JAK家族酶的情况下，选择性地靶向并抑制TYK2可能可以减缓炎症反应并维持保护免疫功能。VTX958在单剂量递增（SAD）与多剂量递增（MAD）的1期临床试验当中展现了积极的结果。该药物耐受性良好，在体内展现出剂量相关的暴露与分布程度，以及剂量相关的强大药效学作用。此积极结果将促使Ventyx推动此药物进入多项自身免疫疾病相关的临床2期试验。GRANITE：1/2期临床试验数据公布GRANITE是一种基于肿瘤新抗原的mRNA疫苗。这款疗法利用其专有的人工智能平台EDGE识别新抗原，然后利用腺病毒载体（GRT-C901）和自我扩增mRNA载体（GRT-R902）递送筛选出的新抗原，旨在引发显著的T细胞反应，特别是CD8+ 细胞毒性T细胞。GRANITE针对晚期转移性实体瘤的1/2期试验的中期结果已发表在《自然医学》杂志上。研究结果显示，GRANITE能够产生强大，持久和功能性的肿瘤特异性CD4+和CD8+ T细胞反应，这些反应在一系列疾病环境中都具有潜在的广泛适用性。Altocetra：以色列卫生部批准启动1/2期临床试验Altocetra是一种在研通用的现货型细胞疗法，旨在将巨噬细胞重新编程为其稳态状态。在实体肿瘤、败血症等疾病中，巨噬细胞脱离稳态与疾病的严重程度显著相关。通过恢复巨噬细胞内稳态，Altocetra可以单独或与其它治疗药物进行组合，具有提供新的免疫治疗作用机制的潜力。近期，Enlivex宣布以色列卫生部（MOH）批准启动一项单独使用Altocetra以及与PD-1抑制剂联合使用治疗晚期实体肿瘤的1/2期临床试验，旨在评估其安全性，耐受性和初步疗效。临床前研究显示，Altocetra与PD-1抑制剂联用在卵巢癌小鼠模型中获得了实质性的、统计学上显著的生存获益。DWP213388：IND申请获得FDA许可Daewoong Pharmaceutical于近日宣布，FDA已批准其用于自身免疫性疾病的新候选药物DWP213388的IND申请，将启动1期临床试验。DWP213388是一种能够选择性地抑制布鲁顿酪氨酸激酶（BTK）和白细胞介素-2诱导的T细胞激酶（ITK）的双靶点抑制剂，可以同时抑制B细胞和T细胞，因此具有比传统的单作用抑制剂更高的疗效潜力。在许多临床前模型中，这种双重活性在预防或减少自身免疫性疾病方面是安全有效的。BBP-671：1期临床试验完成首例患者给药BridgeBio Pharma于近日宣布，其用于治疗辅酶A（CoA）缺乏症引起的相关疾病的在研口服疗法BBP-671已在1期临床试验中完成了首例患者给药。BBP-671是一种PanK激活剂，旨在通过变构调节泛酸激酶（CoA生物合成途径中的关键酶）来提高CoA水平。该药正在被开发为CoA代谢不足疾病的潜在疗法，包括丙酸血症（PA），甲基丙二酸血症（MMA）和泛酸激酶相关神经变性（PKAN）。NM8074：启动疗效试验NovelMed Therapeutics宣布FDA批准其研究性药物NM8074于2023年第一季度在C3肾小球病（C3G）患者中启动疗效试验。C3G是原发性肾小球肾炎的一种罕见和严重形式，以补体失调为特征。NM8074是一种人源化单克隆抗体，能够以皮摩尔亲和力结合丝氨酸酯酶（Bb）并表现出双重特异性。这种蛋白酶抑制剂单克隆抗体阻断了由替代途径（AP）激活产生的两种强大的蛋白酶（C3和C5转化酶）的形成，且不会阻断对宿主防御感染至关重要的经典途径（CP）。在一项针对健康患者的1期研究中，NM8074能在较长时间内有效抑制人血清中的AP且安全性良好，表明该药具有治疗C3G的潜力。GCC19CART：首位患者入组1期临床试验Innovative Cellular Therapeutics宣布其开发的CAR-T细胞疗法GCC19CART的1期试验已完成了首位患者入组。该研究（NCT05319314）是一项开放标签、单臂、多中心的1期剂量递增试验，旨在评估GCC19CART在复发/难治性转移性结直肠癌患者中的安全性、耐受性、有效性、药代动力学和药效学。药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息参考资料：[1] Viridian Announces Positive Initial Clinical Data from Ongoing Phase 1/2 Trial Evaluating VRDN-001 in Patients with Thyroid Eye Disease (TED). Retrieved August 15, 2022, from https://investors.viridiantherapeutics.com/news-releases/news-release-details/viridian-announces-positive-initial-clinical-data-ongoing-phase[2] Combination with Nivolumab for the Treatment of Relapsed/Refractory Classical Hodgkin Lymphoma (cHL). Retrieved August 16, 2022 from https://www.tessacell.com/2022/08/17/tessa-therapeutics-doses-first-patient-in-phase-1b-clinical-trial-investigating-tt11-in-combination-with-nivolumab-for-the-treatment-of-relapsed-refractory-classical-hodgkin-lymphoma-chl/[3] VENTYX BIOSCIENCES ANNOUNCES POSITIVE TOPLINE PHASE 1 DATA FOR ITS SELECTIVE ALLOSTERIC TYK2 INHIBITOR VTX958. Retrieved August 16, 2022 from https://ir.ventyxbio.com/news-releases/news-release-details/ventyx-biosciences-announces-positive-topline-phase-1-data-its-0[4] Nature Medicine Publishes Interim Results from Gritstone bio’s Phase 1/2 Study of GRANITE, Individualized Neoantigen Vaccine for Solid Tumors. Retrieved August 15, 2022, from https://ir.gritstonebio.com/news-releases/news-release-details/nature-medicine-publishes-interim-results-gritstone-bios-phase[5] Enlivex Receives Israeli Ministry of Health Approval for the Initiation of a Phase I/II Trial Evaluating Allocetra™ Alone and in Combination with a PD1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors. Retrieved August 17, 2022, from https://enlivex.com/investor-relations/[6] Daewoong Pharmaceutical Announces US FDA Clearance of IND Application for DWP213388, First-in-class Irreversible Oral Dual Acting inhibitor for Autoimmune Diseases. Retrieved August 16, 2022, from https://www.prnewswire.com/news-releases/daewoong-pharmaceutical-announces-us-fda-clearance-of-ind-application-for-dwp213388-first-in-class-irreversible-oral-dual-acting-inhibitor-for-autoimmune-diseases-301605511.html[7] Bridgebio pharma announces dosing of first patient in phase 1 trial of bbp-671, a potential best-in-class treatment for propionic acidemia (pa) and methylmalonic acidemia (mma). Retrieved August 18, 2022, from https://investor.bridgebio.com/news-releases/news-release-details/bridgebio-pharma-announces-dosing-first-patient-phase-1-trial[8] Alternative Pathway Blocker Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Efficacy Trial in C3 Glomerulopathy (C3G) Patients. Retrieved August 15, 2022, from https://www.prnewswire.com/news-releases/alternative-pathway-blocker-anti-bb-antibody-nm8074-receives-us-fda-clearance-to-start-efficacy-trial-in-c3-glomerulopathy-c3g-patients-301605303.html[9] Innovative Cellular Therapeutics (ICT) Announces First Patient Enrolled for the Company’s Phase I Trial of GCC19CART for Relapsed/Refractory Metastatic Colorectal Cancer. Retrieved August 15, 2022, from https://www.ictbio.com/news/innovative-cellular-therapeutics-ict-announces-first-patient-enrolled-for-the-companys-phase-i-trial-of-gcc19cart-for-relapsed-refractory-metastatic-colorectal-cancer/免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

- Initial data readout for patients with PA and MMA expected in the first half of 2023 - Interim data from healthy individuals, reported earlier this year, showed that BBP-671 was detected in plasma and cerebrospinal fluid (CSF) at concentrations above predicted therapeutic thresholds, suggesting the compound has the potential to impact key systemic and neurological complications of PA and MMA - BridgeBio is in active discussions with regulators and expects to launch a pivotal Phase 2/3 clinical study of BBP-671 in pantothenate kinase-associated neurodegeneration (PKAN) in 2023 - If successful, BBP-671 has potential to be a best-in-class therapy for PA, MMA, and PKAN patients, as well as the first approved oral therapy for the treatment of systemic complications caused by CoA deficiencies PALO ALTO, Calif., Aug. 18, 2022 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, today announced that the first patient has been dosed in its Phase 1 clinical trial of BBP-671, an investigational oral therapy being developed for the potential treatment of conditions caused by coenzyme A (CoA) deficiencies. BBP-671 is an investigational oral therapy intended to increase CoA levels by allosterically modulating pantothenate kinases, key enzymes in the CoA biosynthesis pathway. It is being developed as a potential therapy for diseases in which CoA metabolism is deficient, including propionic acidemia (PA), methylmalonic acidemia (MMA), and pantothenate kinase-associated neurodegeneration (PKAN). PA, MMA, and PKAN affect an estimated 7,000 patients in the United States and European Union collectively, with PA and MMA typically diagnosed in early infancy. BBP-671 is based on breakthrough scientific developments from St. Jude Children’s Research Hospital in Memphis, Tennessee. The first-in-human Phase 1 study of BBP-671 is a single- and multiple-ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BBP-671. The first part of the study evaluated BBP-671 in healthy individuals and the second part of the study is evaluating BBP-671 in PA and MMA patients. Positive interim data from healthy individuals were reported earlier this year. The first patient dosed in the second part of the trial has PA. In this part of the study, up to eight PA patients and eight MMA patients will receive BBP-671. Safety and tolerability will be assessed, as well as the PK and PD of BBP-671 using validated bioanalytical assays. A wide range of disease-related biomarkers with potential clinical relevance will be monitored during the study and compared to baseline values. The potential use of biomarkers for PA and MMA as surrogate endpoints in clinical trials for metabolic diseases is a subject of active discussion among key opinion leaders in the field.1 “We are eager to advance the trial of BBP-671 in the hope that it will provide a positive improvement for patients, valuable data, and ultimately lead to a meaningful therapy for patients who currently have no approved treatment options,” said Zineb Ammous, M.D., clinical geneticist and Medical Director of The Community Health Clinic in Topeka, Indiana, which specializes in rare genetic conditions. PA and MMA are rare metabolic disorders caused by mutations in genes that impact the development of enzymes that participate in amino acid metabolism, leading to life-threatening metabolic decompensations, as well as long-term complications involving multiple organ systems, including the heart, pancreas, kidney, liver, and brain. The current standard of care includes dietary restrictions, supplementation, and sometimes liver and/or kidney transplantation but unmet need remains high due to the long-term and life-threatening impact of these diseases. “Currently, the majority of individuals with PA and MMA are being diagnosed through newborn screening and are on a strict diet and regimen of supplements and medications. PA and MMA patients experience life-threatening metabolic decompensations, as well as many other serious complications as a result of their disease. We are hopeful that by creating a therapy designed to target the disease by modulating fundamental metabolic pathways, we may be able to treat a condition that impacts young people so early in their lives.,” said Jerry Vockley, M.D., Ph.D., Chief of Genetic and Genomic Medicine and Director of the Center for Rare Disease Therapy at the University of Pittsburg Medical Center (UPMC) Children's Hospital of Pittsburgh, Pennsylvania. Initial data from the second part of this clinical trial are expected in the first half of 2023. The company also plans to initiate a pivotal Phase 2/3 clinical study in PKAN in 2023. “We are excited by biomarker changes observed with BBP-671 in a preclinical study using a mouse model for PA, which were associated with improved survival. Individuals diagnosed with PA and MMA and their families currently have no treatment options beyond dietary management and liver and/or kidney transplant, and we hope that BBP-671 may represent a novel therapeutic strategy for these diseases.” said Uma Sinha, Ph.D., Chief Scientific Officer of BridgeBio. More information about the ongoing Phase 1 clinical trial of BBP-671 (study number NCT04836494) can be found here on the ClinicalTrials.gov website. References 1 Longo, N. et al. Journal of Inherited Metabolic Disease. 2022;45:2. About BridgeBio Pharma, Inc. BridgeBio Pharma, Inc. (BridgeBio) is a commercial-stage biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio’s pipeline of development programs ranges from early science to advanced clinical trials. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com and follow us on LinkedIn and Twitter. BridgeBio Pharma, Inc. Forward-Looking Statements This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “will,” and variations of such words or similar expressions.  We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.  These forward-looking statements, including statements relating to the timing and prospects of success for the development of BBP-671, including plans for an initial data readout from the second part of the Phase 1 clinical study for patients with PA and MA in the first half of 2023, the expected initiation of a pivotal Phase 2/3 clinical study in PKAN in 2023, and the potential for BBP-671, if successful, to be a best-in-class therapy for PA, MMA, and PKAN patients, as well as the first approved oral therapy for the treatment of systemic complications caused by CoA deficiencies, reflect our current views about our plans, intentions, expectations, strategies and prospects, and are based on the information currently available to us and on assumptions we have made and are not forecasts, promises nor guarantees. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by these forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved.  Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of our product candidates to treat genetically driven diseases and cancers with clear genetic drivers, our anticipated cash runway and our being fully funded through the completion of the BBP-671 and our ability to access additional funding upon achievement of portfolio milestones, as well as those risks set forth in the Risk Factors section of our most recent Annual Report on Form 10-K and BridgeBio Pharma’s other SEC filings. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Contact: Grace Rauh Grace.rauh@bridgebio.com (917) 232-5478