MIAMI--(BUSINESS WIRE)--Terran Biosciences Inc. ('Terran'), a biotech platform company developing therapeutics and technologies for patients with neuropsychiatric illnesses, has announced the development of TerXT, a combination of novel prodrugs of xanomeline and trospium designed to be long-acting treatments for schizophrenia.

迈阿密——（商业新闻短讯）——Terran Biosciences Inc.（“Terran”）是一家为神经精神疾病患者开发治疗和技术的生物技术平台公司，已宣布开发TerXT，它是xanomeline和trospium的新型前药组合，旨在成为精神分裂症的长效治疗药物。

Terran has received notice of patent claims found to be allowable from the United States Patent and Trademark Office (USPTO) for the composition of matter for the world’s first prodrugs of xanomeline..

Terran收到了美国专利商标局（USPTO）关于世界上第一种xanomeline前药物质组成的专利申请通知。。

To develop TerXT, Terran sought to overcome inherent pharmacokinetic and physical property limitations of the compounds xanomeline and trospium, such as poor colonic absorption and high aqueous solubility, by utilizing a novel prodrug strategy. These prodrugs were designed to enable fixed-dose combinations for once-daily oral administration (“TerXT”) and long-acting intramuscular injection with multi-month duration (“TerXT LAI”).

为了开发TerXT，Terran试图通过利用新的前药策略来克服化合物xanomeline和trospium固有的药代动力学和物理性质限制，例如结肠吸收差和水溶性高。这些前药旨在使固定剂量组合能够每天口服一次（“TerXT”）和持续数月的长效肌内注射（“TerXT LAI”）。

These new forms could potentially allow Terran to pursue accelerated development and regulatory strategies such as the FDA 505(b)(2) approval pathway..

这些新形式可能会使Terran寻求加速发展和监管策略，如FDA 505（b）（2）批准途径。。

Recent clinical trials of an oral, twice-daily, fixed-dose combination of xanomeline, a compound invented in the 1990s, and trospium, invented in the 1960s, have demonstrated safety and efficacy in treating schizophrenia. This combination has been submitted to the FDA for approval on the 505(b)(1) path and is currently undergoing FDA review, with a decision expected by September this year.

最近的临床试验表明，90年代发明的化合物xanomeline和60年代发明的trospium的口服，每日两次，固定剂量组合在治疗精神分裂症方面具有安全性和有效性。该组合已提交给FDA批准505（b）（1）路径，目前正在接受FDA审查，预计将于今年9月做出决定。

If the FDA approves the xanomeline/trospium combination, Terran plans to pursue the rapid 505(b)(2) approval pathway for TerXT and TerXT LAI. This regulatory pathway could potentially enable Terran to use pharmacokinetic bridging studies and leverage existing safety and efficacy data from completed trials to bring Terran’s next-generation therapeutics to market approximately five years after the first xanomeline/trospium approval, helping to broaden access for patients, improve the use profile, and increase affordability..

如果FDA批准xanomeline/trospium组合，Terran计划寻求TerXT和TerXT LAI的rapid 505（b）（2）批准途径。这一监管途径可能使Terran能够使用药代动力学桥接研究，并利用已完成试验的现有安全性和有效性数据，在第一次xanomeline/trospium批准大约五年后将Terran的下一代治疗药物推向市场，有助于扩大患者的使用范围，改善使用情况，提高负担能力。。

In order to successfully overcome the pharmacokinetic limitations of xanomeline and trospium, Terran assembled a team of the world’s experts in medicinal chemistry, resulting in over 10,000 new prodrugs designs. Terran’s PK modeling team developed a predictive model of both xanomeline and trospium across a vast spectrum of different formulation designs and release profiles to determine the optimal pharmacokinetic parameters and ratios.

为了成功克服xanomeline和trospium的药代动力学局限性，Terran组建了一个由世界药物化学专家组成的团队，产生了10000多种新的前药设计。Terran的PK建模团队在广泛的不同配方设计和释放曲线中开发了xanomeline和trospium的预测模型，以确定最佳的药代动力学参数和比例。

Terran utilized a team of 200 chemists to synthesize over 500 prodrugs, which then underwent preclinical testing, including 285 in vitro and 365 in vivo studies..

Terran利用200名化学家的团队合成了500多种前药，然后进行了临床前测试，包括285项体外研究和365项体内研究。。

“We’ve seen the prodrug approach significantly improve long-acting formulations of some of the most effective antipsychotics to date, including Aristada®, Haldol® Decanoate, and Invega Hafyera®, to the great benefit of patients,” said Sam Clark, MD, PhD, Terran’s founder and CEO, and inventor on the patent.

“我们已经看到前药方法显着改善了一些迄今为止最有效的抗精神病药物的长效配方，包括Aristada®，Haldol®癸酸酯和Invega Hafyera®，为患者带来了巨大的益处，”Terran的创始人兼首席执行官兼专利发明人Sam Clark博士说。

“However, these improved forms were not developed until many years after the original compounds were first approved; in some cases, decades later. At Terran, we believe patients shouldn’t have to wait for the latest technology and we believe that our prodrugs of xanomeline and trospium will enable improvements in ease of use and quality of life on a much more rapid timescale than has historically been achieved.”.

“然而，这些改进的形式直到最初的化合物首次获得批准后的许多年才开发出来；在某些情况下，是几十年后。在Terran，我们认为患者不应该等待最新的技术，我们相信我们的xanomeline和trospium前药将能够在比历史上更快的时间尺度上改善易用性和生活质量。”。

ABOUT TERRAN BIOSCIENCES

关于人族生物科学

Terran Biosciences is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Terran has built a CNS-focused, tech-enabled drug development platform and is rapidly advancing a number of assets that include late-stage therapeutics for schizophrenia, an FDA-cleared neuroimaging software platform, and a drug design engine that has generated first-in-class and best-in-class psychedelic-based therapeutics and novel prodrugs optimized for patient use.

Terran Biosciences是一家生物技术平台公司，为神经和精神疾病患者开发治疗和技术组合。Terran已经建立了一个以中枢神经系统为中心的、技术支持的药物开发平台，并正在迅速推进一系列资产，包括精神分裂症晚期治疗、FDA批准的神经影像软件平台，以及一个药物设计引擎，该引擎产生了一流和一流的基于迷幻药的治疗方法和针对患者使用进行优化的新型前药。

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For more information on TerXT visit www.TerXT.com

For more information on TerXT visit www.TerXT.com