HARTFORD, Conn., Feb. 22, 2024 /PRNewswire/ -- Thelansis Knowledge Partners is a specialized business research and consulting company that provides pharmaceutical and biopharmaceutical companies with data-driven research, insights, and decision-making support throughout the product life cycle.

康涅狄格州哈特福德，2024年2月22日/PRNewswire/--Thelansis Knowledge Partners是一家专业的商业研究和咨询公司，在整个产品生命周期中为制药和生物制药公司提供数据驱动的研究、见解和决策支持。

Psychedelics (e.g., psilocybin, MDMA) are mostly Schedule 1 substances in the United States; however, given their potential to effectively treat psychiatric conditions, Thelansis's analysts are noting renewed interest in psychedelics's clinical development for medical purposes (with a significant increase in pipeline activity) and that potential approval pathways are under consideration with drug regulators.

迷幻药（例如裸盖菇素，MDMA）在美国主要是附表1物质；然而，鉴于其有效治疗精神疾病的潜力，Thelansis的分析师们注意到，人们对迷幻剂的医疗用途临床开发（管道活动显着增加）重新产生了兴趣，药物监管机构正在考虑潜在的批准途径。

Specifically, multiple psychedelics (in association with psychotherapy) are in various phases of drug development for the difficult-to-manage psychiatric indications (e.g., severe PTSD, treatment-resistant depression, bipolar depression, suicidal ideation).1 Of psychedelics, MDMA-assisted psychotherapy (by Lykos Therapeutics [previously MAPS Public Benefit Corporation]) would be the first approved therapy for moderate to severe posttraumatic stress disorder (PTSD), which comprises approximately two-thirds of PTSD patients (based on Thelansis's primary market research).2 MDMA-assisted therapy is in preregistration in the United States and is expected to receive USFDA-approval in late-2024.

具体来说，多种迷幻剂（与心理治疗相关）正处于药物开发的不同阶段，用于难以管理的精神适应症（例如，严重创伤后应激障碍，难治性抑郁症，躁郁症，自杀意念）。1种迷幻剂，MDMA辅助心理治疗（由Lykos Therapeutics[以前的MAPS公益公司]）这将是第一个被批准用于治疗中度至重度创伤后应激障碍（PTSD）的疗法，该疗法约占创伤后应激障碍患者的三分之二（基于Thelansis的一级市场研究）。2 MDMA辅助疗法正在美国进行预注册，预计将于2024年底获得美国食品和药物管理局（USFDA）的批准。

Notably, few drugs are USFDA-approved for PTSD and with nearly half of moderate to severe PTSD patients achieving remission in three months after monthly administrations of MDMA-assisted therapy,3 this therapy is set to revolutionize the treatment of PTSD patients, as highlighted by a KOL..

值得注意的是，很少有药物被美国食品和药物管理局批准用于创伤后应激障碍，近一半的中重度创伤后应激障碍患者在每月服用MDMA辅助治疗后三个月内达到缓解，3这种治疗将彻底改变创伤后应激障碍患者的治疗方法，正如KOL所强调的那样。。

The next psychedelic that could reach the U.S. market is COMP360 psilocybin therapy (by COMPASS Pathways) for treatment-resistant depression (TRD), which comprises nearly one-third of patients with major depressive disorder (MDD).2 The therapy is in Phase 3 of clinical development and could receive USFDA approval by 2026.

下一个可能进入美国市场的迷幻药是COMP360 psilocybin疗法（通过COMPASS Pathways），用于治疗难治性抑郁症（TRD），该疗法占重性抑郁症（MDD）患者的近三分之一。2该疗法处于临床开发的第三阶段，可能在2026年获得USFDA的批准。

Notably, the therapy targets some key clinical unmet needs in TRD patients, for example, a rapid onset of action, less-frequent dosing, durability of response.4 Because of psychedelics's unique treatment schedule (e.g., associated psychotherapy sessions) and expected regulatory hurdles (e.g., administration in designated centers to prevent misuse), many interviewed psychiatrists (by Thelansis) expressed the need for trainings by drug marketers and the need for guidelines to minimize the burden of logistics while drug administration.

值得注意的是，该疗法针对TRD患者的一些关键临床未满足的需求，例如，起效迅速，给药频率较低，反应持久性。4由于迷幻剂独特的治疗时间表（例如，相关的心理治疗课程）和预期的监管障碍（例如，在指定中心进行管理以防止滥用），许多接受采访的精神科医生（通过Thelansis）表示需要药品营销人员进行培训，并需要制定指导方针，以尽量减少药品管理部门的物流负担。

Thelansis research suggests that these therapies could have pricing potential similar to the annual cost of treatment for Janssen's Spravato (or S-ketamine, which belongs to another class of psychedelics) for TRD. Spravato, although launched for TRD in 2019, struggled postlaunch due to various factors, including market access hurdles, site-specific availability, and lack of clarity on the administration schedule for chronic treatment, as noted by some interviewed KOLs.2 Nevertheless, the drug reached nearly $600 million in sales (after rebates/discounts) in the United States in 2023.5.

Lansis研究表明，这些疗法的定价潜力可能与詹森针对TRD的Spravato（或s-氯胺酮，属于另一类迷幻药）的年度治疗费用相似。Spravato虽然于2019年推出TRD，但由于各种因素，包括市场准入障碍，特定地点的可用性以及慢性治疗的管理时间表缺乏明确性，因此在发布后遇到了困难，正如一些接受采访的KOL所指出的那样。2然而，2023年，该药物在美国的销售额（扣除折扣/折扣）达到近6亿美元。

Thelansis forecasts blockbuster sales potential for each of the MDMA-assisted psychotherapy in moderate to severe PTSD and of COMP360 psilocybin therapy in TRD within five years of their respective U.S.-market launches.6

Thelansis预测，中重度创伤后应激障碍的MDMA辅助心理治疗和TRD中的COMP360 psilocybin治疗在各自的美国市场推出后的五年内都具有巨大的销售潜力。6

KOL perspectives:

KOL观点：

'I am excited to see such therapies in clinical practice and would welcome these developments in the field of psychiatry, primarily because psychedelics could resolve disease symptoms after few administrations, unlike current treatments requiring chronic administration and have limited effect sizes.' 'TRD patients encounter high burden of polypharmacy, with current therapies having low response and remission rates.

“我很高兴在临床实践中看到这种疗法，并欢迎精神病学领域的这些发展，主要是因为迷幻剂可以在几次给药后解决疾病症状，这与目前需要长期给药的治疗方法不同，并且效果有限。”TRD患者面临多种药物的高负担，目前的治疗反应和缓解率较低。

Availability of psychedelic(s) with few administrations in a year and offering high remission rate could change the treatment pathway for these patients.'.

在一年内很少服用迷幻剂并提供高缓解率的情况下，迷幻剂的可用性可能会改变这些患者的治疗途径。”。

According to an interviewed U.S.-based neurologist by Thelansis – 'We desperately need disease-modifying treatments for many neurodegenerative conditions. I hope that CNS field will witness novel therapies soon, including gene therapies for rare CNS disorders and more efficacious treatments for psychiatric disorders, for which patients have increased tremendously.'.

根据接受Thelansis采访的美国神经科医生的说法，“我们迫切需要针对许多神经退行性疾病的疾病缓解疗法。我希望中枢神经系统领域很快会看到新的治疗方法，包括罕见中枢神经系统疾病的基因治疗和精神疾病的更有效治疗，患者数量大大增加。”。

Closing statement:

闭幕词：

As psychedelics would be beneficial for treatment-nonresponders or severe patients, the commercial opportunities are multiple for in-pipeline psychedelic therapies.

由于迷幻剂对治疗无反应者或重症患者有益，因此管道内迷幻剂治疗的商业机会是多重的。

In addition, the report answers key questions such as,

此外，该报告回答了以下关键问题：，

How large is the treatment-eligible patient pool for Psychedelics (e.g., psilocybin, MDMA) in the 8 major markets (including the U.S., EU5, Japan, and China)? How will this product change the market dynamics in the next ten years (2023-2033)?

在8个主要市场（包括美国，欧盟5国，日本和中国），迷幻剂（例如裸盖菇素，MDMA）的治疗合格患者库有多大？该产品将如何改变未来十年（2023-2033年）的市场动态？

What is the probable opportunity for Psychedelics (e.g., psilocybin, MDMA) to address the unmet needs of other TAs? What will be the preferences of HCPs? Where does it fit in early lines and late lines of treatment? What are the KOL opinions/quotes on Psychedelics (e.g., psilocybin, MDMA)?

迷幻药（例如psilocybin，MDMA）解决其他助教未满足需求的可能机会是什么？HCP的偏好是什么？它适合早期和晚期治疗吗？KOL对迷幻药（如裸盖菇素、摇头丸）有什么看法/引用？

What are the various patient segments that could be targeted?

可以针对哪些不同的患者群体？

What is the market size (in terms of sales) for Psychedelics (e.g., psilocybin, MDMA)? What does the patient share? How will this landscape evolve in the next ten years?

迷幻药（如裸盖菇素、MDMA）的市场规模（销售额）是多少？患者分享了什么？未来十年，这一格局将如何演变？

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Website:  Thelansis.com  For more information, please contact: Chinmaya Kumar SenapatiEmail- [email protected]+91-6397-349664

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SOURCE Thelansis Knowledge Partners LLP

来源：Lansis Knowledge Partners LLP