Panic Disorder

FRIENDSWOOD, Texas--( BUSINESS WIRE )--Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced new data highlighting the value of its IDgenetix pharmacogenomic (PGx) test in guiding medication recommendations for patients with mental health conditions who are 65 and older. The data will be shared via a poster presentation at the 2024 American Association for Geriatric Psychiatry (AAGP) Annual Meeting, taking place March 15-18 in Atlanta. “Pharmacogenomics has been increasingly used to identify genetic variations associated with drug response; however, its potential in older adults who are more likely to be on multiple medications and experience adverse drug events has not been fully explored,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “This study found that, despite all patients carrying potentially clinically significant genetic variants, one-third of medication recommendations were due to drug-drug interactions and lifestyle factors provided on the IDgenetix report. This is especially important as real-world evidence shows that polypharmacy, taking five or more prescription medications, occurs in more than half of elderly patients. 1 ” Poster Title: Pharmacogenomic Characteristics and IDgenetix-Guided Medication Management for Older Adults with Depression and Anxiety Presenting Author: Raymond A. Lorenz, Pharm.D., BCPP, Castle Biosciences, Inc. Date and Time: Saturday, March 16, from 5-7 p.m. Eastern Time Location: Grand Ballroom, Hanover Hall and Embassy Hall Exhibition Level at the Hyatt Regency Atlanta IDgenetix is an advanced 3-in-1 PGx test that incorporates genetic information, drug-drug interactions and lifestyle factors to produce a report that can help clinicians select optimal medications for their patients with depression, anxiety and other neuropsychiatric illnesses. The study analyzed gender, age and diagnosis, including attention-deficit/hyperactivity disorder, anxiety, bipolar disorder, depression, obsessive-compulsive personality disorder, pain, post-traumatic stress disorder and schizophrenia, from a sample of IDgenetix reports for patients 65 and older (n=737). The most common psychiatric diagnoses for which IDgenetix was ordered included depression and anxiety. Additionally, 58% of the patients in the study were on five or more medications, with an average of seven, at the time of testing. All patients in the study had genetic polymorphisms that could impact medication selection in at least three of the 15 genes on the IDgenetix report. While drug-gene interactions accounted for 66% of all medication recommendations, drug-drug interactions and lifestyle factors accounted for 34% (27% and 7%, respectively), demonstrating the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. About IDgenetix IDgenetix is a pharmacogenomic (PGx) test for depression, anxiety and other mental health conditions designed to analyze a patient’s genetic make-up to guide timely and evidence-based decisions on the optimal drug for each patient. IDgenetix is designed to provide important genetic information to clinicians to help guide personalized treatment plans for their patients, with the potential to help patients achieve a faster therapeutic response and improve their chances of remission by identifying appropriate medications more efficiently than the standard of care trial-and-error approach. IDgenetix provides drug-drug and drug-gene interactions and is supported by a published, peer-reviewed randomized controlled trial that demonstrated clinical utility over the standard of care when physicians used IDgenetix prior to prescribing a medication. IDgenetix is currently reimbursed by Medicare for the following eight mental health conditions: major depressive disorder, schizophrenia, bipolar disorder, anxiety disorders, panic disorder, obsessive-compulsive personality disorder, post-traumatic stress disorder and attention deficit hyperactivity disorder. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit www.CastleBiosciences.com and connect with us on LinkedIn , Facebook , X and Instagram . DecisionDx-Melanoma, DecisionDx-CM Seq , DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UM Seq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the potential of pharmacogenomics to affect medication recommendations for older adults; and the value of the IDgenetix 3-in-1 test in providing tailored guidance to help clinicians select the optimal medications for their patients. The words “believe,” “can” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. 1. Wang X, Liu K, Shirai K, et al. Prevalence and trends of polypharmacy in U.S. adults, 1999–2018. Glob Health Res Policy . 2023;8(25). https://doi.org/10.1186/s41256-023-00311-4

关注并星标CPHI制药在线       美东时间2月20日，艾伯维宣布长期担任首席执行官（CEO）一职的Richard A. Gonzalez将卸任，现任总裁兼首席运营官（COO）的Robert A. Michael将接任CEO一职，任命于2024年7月1日起生效。       在艾伯维自雅培分拆前，Richard A. Gonzalez已在雅培工作了约30年。2013年，艾伯维从雅培分拆出来并独立运营，Richard A. Gonzalez开始担任艾伯维CEO。在他担任CEO期间，艾伯维的市值从最初的540亿美元上涨至如今的3000多亿美元。       Robert A. Michael则是在艾伯维分拆完成后，成立并领导了艾伯维的第一个财务规划组织，担任艾伯维财务规划和分析副总裁。随后，他担任了一系列领导职务，例如副总裁、商业运营总监、财务总监等。       值得一提的是，艾伯维眼下正面临巨大挑战，其重磅炸弹--自身免疫药物修美乐（Humira）正面临仿制药的冲击。据艾伯维公布的2023年财报，去年修美乐营收为144.04亿美元，同比下滑32.2%；公司总营收为543.18亿美元，同比下滑6.4%；实现净利润48.63亿美元，同比下滑58.91%。       一代"药王"修美乐的谢幕，使艾伯维业绩受到较大冲击。为了培养新的增长引擎，穿越周期，过去一年，艾伯维做了哪些改变？       砍掉多条管线       在2023年，艾伯维终止了多个产品的研发，管线涉及ADC药物、单抗及CAR-T产品等。       2023年3月，艾伯维放弃了与CytomX Therapeutics合作开发的CX-2029，这是一款靶向CD71的ADC。CD71即转铁蛋白受体，在一些实体瘤、血液瘤以及许多正常组织上高表达，而其在正常组织上的表达和潜在毒性限制了其应用。为了解决这一难题，CytomX开发了Probody技术平台，该技术平台通过利用掩蔽肽将抗体的目标结合区域掩盖，进而避免其在健康组织中发挥毒性。       CX-2029就是在Probody技术平台基础上开发的。2016年，艾伯维与CytomX达成合作，共同开发CX-2029。7年过去，CX-2029的临床研究已推进至II期，然而疗效并不突出。2023年3月27日，CytomX在其2022年报中表明，艾伯维放弃了与其合作的CX-2029，不再继续推进其研究。       2023年7月，艾伯维由于资产组合与战略决策原因，退回了加科思自研创新药SHP2抑制剂的全球权益。两家公司于2020年5月签署合作协议，共同开发SHP2抑制剂JAB-3068和JAB-3312。       2023年9月14日，艾伯维终止了与Harpoon Therapeutics公司的合作，决定不对其引进的HPN217项目行使独家许可权，该项目"已经并将继续由Harpoon独家拥有"。       HPN217是Harpoon Therapeutic开发的一种BCMA/CD3/HSA的三特异性抗体，基于TriTac平台研发。两家公司于2019年11月达成协议，获得HPN217的全球独家授权。       2023年9月25日，艾伯维终止了与天境生物就CD47抗体药物 lemzoparlimab（来佐利单抗）的合作协议。两家公司于2020年9月签订合作协议，艾伯维获得了 lemzoparlimab在大中华区以外的独家开发及商业化权益。不过在2022年8月，艾伯维就结束了lemzoparlimab 的两项Ib期试验。       除了退回多款外部产品外，艾伯维还终止了所有囊性纤维化（CF）项目以及终止多款ADC药物研发，包括靶向TNF-α的ADC产品ABBV-154、靶向SEZ6的ABBV-011和靶向PTK7的ABBV-647。       对于艾伯维来说，通过以上裁撤低价值管线，优化业务布局，不失为处于阵痛期的一个好选择。       神经精神领域，艾伯维重点布局       2023年12月，艾伯维和Cerevel Therapeutics达成协议，艾伯维将收购Cerevel及其强大的神经科学产品管线，其中包括多款处于临床阶段和临床前候选药物，具有治疗精神分裂症、帕金森病和情绪障碍等多种疾病的潜力。该交易总股权价值为87亿美元。       Cerevel的临床后期产品emraclidine是一种毒蕈碱M4受体的正变构调节剂（PAM），可用于精神分裂症的治疗。此外，emraclidine在治疗阿尔茨海默病和帕金森病等痴呆相关精神病方面也具有潜力。       除emraclidine外，Cerevel还拥有多项在临床上取得进展的项目。Tavapadon是一种用于治疗帕金森病的潜在FIC多巴胺D1/D5选择性部分激动剂，目前正处于III期研究中，具有作为单药和辅助疗法的潜力。Darigabat则是一种α2/3/5选择性GABAA受体PAM，用于治疗难治性癫痫和恐慌症，目前处于临床II期试验阶段。       2023年10月，艾伯维收购了药物发现阶段的生物技术公司Mitokinin，其正在开发一款针对帕金森病的药物MTK-458，它是一种新型PINK1激活剂，可选择性增加PINK1活性，进而解决导致帕金森病发病和进展的线粒体功能障碍。同时，MTK-458在亨廷顿氏病、阿尔茨海默病等疾病模型中的活性也正在研究中。       神经精神领域的研究一直是医学界的重要方向之一，艾伯维也一直在重点布局，通过收购，进一步巩固了艾伯维在神经科学领域的地位。       下一任药王接棒者：Skyrizi、Rinvoq       目前，艾伯维另外两款自免产品IL-23单抗Skyrizi（risankizumab，瑞莎珠单抗）和JAK1抑制剂Rinvoq（乌帕替尼），正在迅速填补修美乐销售额的下降。       Skyrizi于2019年4月获FDA批准上市，用于斑块状银屑病的治疗。目前其最明显的优势是获批适应症数量之多。除斑块状银屑病外，还获批了银屑病关节炎、泛发性脓疱型牛皮癣、红皮病型银屑病等适应症，是所有 IL- 单抗产品中获批适应症数量最多的药物。       Rinvoq于2019年8月获FDA批准上市，是全球首款获批上市的选择性JAK1抑制剂。目前已斩获7项适应症，包括类风湿性关节炎、银屑病关节炎、特应性皮炎、溃疡性结肠炎、强直性脊柱炎、非放射学中轴型脊柱关节炎和克罗恩病。       据Evaluate Pharma预测，到2026年，Skyrizi和Rinvoq的销售总额将达到158亿美元。艾伯维则预计，到2027年，这两款产品销售峰值将超过修美乐的峰值收入--210亿美元。       简单来说，艾伯维秉承的原则就是在自免领域进行自我革命，来完成自我迭代。       翻开艾伯维十余年（2013年从雅培分拆）的发展史，在第一任CEO Richard A. Gonzalez的带领下，不少决策和并购案例都让产业界为之瞩目。如今Richard A. Gonzalez功成身退，艾伯维则处在新旧交替的节点，为了穿越周期，艾伯维近年做了不少努力。在新任CEO的带领下，艾伯维下一个阶段又将迎来什么样的成绩？       参考来源：       1.AbbVie announces appointment of Robert A. Michael as Chief Executive Officer.       2.AbbVie to Acquire Cerevel Therapeutics in Transformative Transaction to Strengthen Neuroscience Pipeline.       3.艾伯维财报【智药研习社近期课程预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

Teletherapy company Talkspace and virtual opioid use disorder treatment company Bicycle Health are partnering to expand access to virtual care for patients of both companies. Talkspace offers therapy for adults, teens 13 to 17, and couples, as well as psychiatric services and medication management. The platform assists individuals suffering from anxiety, depression, bipolar disorder, OCD, panic disorder, PTSD and postpartum depression. Bicycle offers virtual treatment for opioid use disorder, including medication-assisted treatment like Suboxone. The startup currently operates in 25 states. Patients can set up an introductory call with the startup to determine if Bicycle's treatment would work for them and then schedule a virtual appointment to set a care plan and discuss medication-assisted treatment. Patients can also access health coaching and online support groups. Through the partnership, Talkspace patients will have access to opioid use disorder specialty care, including medication, therapists and recovery coaches. Bicycle Health patients will be able to connect with therapists via chat and speak to mental health providers in areas outside of substance use disorder, such as marriage and family therapists. "Opioid use disorder does not exist in a vacuum. We consider the whole person and their environment when recommending the right care plan to help them achieve stable, lasting recovery," Dr. Brian Clear, chief medical officer at Bicycle Health, said in a statement. "Like patients in all care settings, Bicycle Health patients often experience depression, anxiety or other behavioral conditions beyond their addiction and many will benefit from a relationship with a therapist at Talkspace with expertise to meet their needs. Now, in addition to our own internal therapist team, our clinicians have the ability to connect our patients to a therapist at Talkspace quickly and reliably whenever that’s the right choice for any patient." THE LARGER TREND Bicycle Health recently joined HIMSS TV to discuss its partnership with the Federal Bureau of Prisons to provide individuals released from prison continued access to monthly injections of buprenorphine for opioid use disorder. Last year, the company announced it was collaborating with supermarket chain Albertsons to give the telehealth company's providers the ability to prescribe buprenorphine monthly injections for opioid use disorder that can be filled inside Albertsons pharmacies across 17 states. It also partnered with emergency telehealth provider Tele911 to connect patients to continuing care after an overdose or health crisis. In 2022, the company scored $50 million in a Series B funding round, bringing Bicycle's total raise to $83 million. It scored $27 million in a Series A round announced in 2021. Last year, publicly traded Talkspace announced it signed a $26 million contract with New York City's Department of Health and Mental Hygiene to power NYC Teenspace. The three-year program provides free therapy and self-guided mental health resources to teens 13 through 17. The company also reported it partnered with Finland-based Oura, maker of its namesake health-tracking ring. Through the partnership, Talkspace would allow Oura wearers to share their personalized sleep and daily movement data with Talkspace therapists.