Click Therapeutics and Boehringer Ingelheim announced that their co-developed, investigational CT-155 prescription digital therapeutic (PDT) has earned U.S. Food and Drug Administration (FDA) breakthrough device status.

Click Therapeutics和勃林格殷格翰宣布，他们共同开发的研究性CT-155处方数字治疗仪（PDT）已获得美国食品和药物管理局（FDA）突破性设备地位。

CT-155 is a software for mobile devices that’s being studied for use with standard-of-care drug therapy and is designed to treat the negative symptoms of schizophrenia. The duo said it’s one of multiple digital therapeutics under joint development to treat schizophrenia.

CT-155是一种用于移动设备的软件，正在研究与标准护理药物治疗一起使用，旨在治疗精神分裂症的阴性症状。两人表示，这是联合开发的治疗精神分裂症的多种数字疗法之一。

“We are thrilled to receive this Breakthrough Device designation for CT-155 as it brings us one step closer to being able to provide additional treatment options to those living with schizophrenia, where there remains a significant unmet need due to a lack of access to psychosocial intervention therapies,” said Shaheen Lakhan, MD, Ph.D., FAAN, chief medical officer of Click Therapeutics.

Click Therapeutics首席医疗官Shaheen Lakhan博士说：“我们很高兴收到CT-155突破性设备的命名，因为它使我们离能够为精神分裂症患者提供额外的治疗选择又近了一步，因为精神分裂症患者由于缺乏心理社会干预疗法，仍然存在大量未满足的需求。”。

“Our unique therapeutic approach is on track to be the industry’s first-in-class treatment for the negative symptoms of schizophrenia.” .

“我们独特的治疗方法有望成为精神分裂症阴性症状的业界一流治疗方法。”。。

Right now, available antipsychotic medications are indicated for positive symptoms like hallucinations, disorganized speech, and behavior agitation. There aren’t currently approved drugs or devices available to treat schizophrenia’s negative symptoms, which are at the root of significant day-to-day functional impairment. .

目前，可用的抗精神病药物适用于幻觉，言语混乱和行为激动等积极症状。目前还没有批准的药物或设备可用于治疗精神分裂症的阴性症状，这是严重的日常功能障碍的根源。。。

The duo said CT-155 is the first investigational PDT developed as part of the collaboration, which has been in effect since September 2020.

两人说，CT-155是作为合作的一部分开发的第一个研究性PDT，自2020年9月起生效。

“This Breakthrough Device designation is an affirmation of the groundbreaking work by the Boehringer Ingelheim and Click Therapeutics teams to advance the standard of care in schizophrenia. Prescription digital therapeutics, like CT-155, represent the future of medicine. This designation brings us one step closer to that reality by enhancing our ability to work with the FDA on market authorization and accelerate access to this future treatment option,” said Austin Speier, chief strategy officer of Click Therapeutics.

“这一突破性的设备设计肯定了勃林格殷格翰和Click Therapeutics团队为提高精神分裂症的护理标准所做的开创性工作。处方数字治疗，如CT-155，代表了医学的未来。这一设计通过增强我们与FDA在市场授权方面的合作能力，使我们更接近这一现实Click Therapeutics首席战略官奥斯汀·斯皮尔（AustinSpeier）表示。

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