Protagenic Therapeutics Successfully Concludes Third Cohort in Single Dose Portion of Phase 1 Trial for Stress-Related Neuropsychiatric Disorders
Protagenic Therapeutics Successfully Concludes Third Cohort in Single Dose Portion of Phase 1 Trial for Stress-Related Neuropsychiatric Disorders
Next clinical progress update expected in April 2024
下一次臨床進展更新預計將於2024年4月發佈
NEW YORK, NY / ACCESSWIRE / March 27, 2024 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a leader in biopharmaceutical innovation, advances its mission to develop cutting-edge treatments for stress-related neuropsychiatric disorders. The company has reached another milestone by completing three out of five cohorts of healthy volunteers with PT00114, its synthetic version of the stress-regulating peptide TCAP, in a SAD Phase 1 clinical trial. Notably, PT00114 has shown excellent tolerability with no adverse safety findings during these ongoing Phase 1 studies. With promising preclinical efficacy in anxiety, depression, PTSD, and addiction models, PT00114 moves forward in clinical evaluation, representing a step toward potentially transformative therapies.
紐約州紐約/ACCESSWIRE/2024年3月27日/生物製藥創新的領導者Protagenic Therapeutics, Inc.（納斯達克股票代碼：PTIX）推進了爲壓力相關的神經精神疾病開發尖端療法的使命。該公司在一項SAD 1期臨床試驗中完成了五分之三的健康志願者隊列使用其壓力調節肽TCAP的合成版本 PT00114，從而實現了又一個里程碑。值得注意的是，在這些正在進行的 1 期研究中，PT00114 表現出良好的耐受性，沒有不良的安全性發現。PT00114 在焦慮、抑鬱、創傷後應激障礙和成癮模型中的臨床前療效令人鼓舞，臨床評估向前邁進，標誌着朝着潛在的變革性療法邁出了一步。
Key Highlights:
主要亮點：
- Safety Validation: Building on the low dose safety validation announced February 13th, PT00114 has now demonstrated safety at a medium dose of 500 micrograms administered subcutaneously in the third of five planned cohorts of subjects in the single dose portion of the Phase I trial. No adverse reactions were observed among subjects, consistent with the two lower dose cohorts (125 micrograms and 250 micrograms), with no reported injection site reactions or tolerability issues in the week following dosing. Based on preclinical pharmacology, PT00114 is expected to be administered once weekly via subcutaneous injection.
- Clinical Protocol Progress: This marks progress in the ongoing Phase 1/2a trial, designed to assess both healthy volunteers and patients diagnosed with Treatment-Resistant Depression, PTSD, or Generalized Anxiety Disorder. The company plans to enroll the final two cohorts into the single dose portion of the Phase 1 trial within the next month.
- Comprehensive Approach: In addition to monitoring disease status, the trial incorporates biomarker assessments, including circulating cortisol levels, to measure initial treatment response. Dr. Maurizio Fava, Psychiatrist-in-Chief at Massachusetts General Hospital, serves as the Principal Investigator in Protagenic's Phase 1/2a clinical trial with a basket design.
- Strategic Collaboration: Axiom Real-Time Metrics, a CRO/Data Analytics firm, manages the clinical program.
- 安全性驗證：在 2 月 13 日宣佈的低劑量安全性驗證基礎上，PT00114 現已證明在 I 期試驗單劑量部分計劃中的五組受試者中進行皮下給藥 500 微克的中等劑量是安全的。受試者中未觀察到不良反應，這與兩個較低劑量的隊列（125微克和250微克）一致，在給藥後的一週內沒有報告注射部位反應或耐受性問題。根據臨床前藥理學，PT00114 預計將通過皮下注射每週給藥一次。
- 臨床方案進展：這標誌着正在進行的1/2a期試驗的進展，該試驗旨在評估健康志願者和被診斷患有耐藥性抑鬱症、創傷後應激障礙或廣泛性焦慮症的患者。該公司計劃在下個月內將最後兩個隊列納入1期試驗的單劑量部分。
- 綜合方法：除了監測疾病狀況外，該試驗還包括生物標誌物評估，包括循環皮質醇水平，以衡量初始治療反應。麻省總醫院首席精神科醫生毛裏齊奧·法瓦博士是Protagenic採用籃子設計的1/2a期臨床試驗的首席研究員。
- 戰略合作：首席投資官/數據分析公司Axiom Real-time Metrics負責管理臨床項目。
About Protagenic Therapeutics, Inc.:
Protagenic Therapeutics, Inc. (Nasdaq: PTIX) is dedicated to pioneering therapeutics based on neuro-active peptides to alleviate the negative effects of stress and treat stress-related disorders such as anxiety, depression, PTSD, and addiction. For more information, visit .
關於 Protagenic Therapeutics, Inc.：
Protagenic Therapeutics, Inc.（納斯達克股票代碼：PTIX）致力於開發基於神經活性肽的開創性療法，以減輕壓力的負面影響並治療與壓力相關的疾病，例如焦慮、抑鬱、創傷後應激障礙和成癮。欲了解更多信息，請訪問。
About PT00114:
PT00114, a 41-amino-acid residue synthetic peptide, shows promise as a novel treatment for serious neuro-psychiatric conditions, including depression, anxiety, and PTSD. It is a synthetic form of the naturally occurring brain peptide TCAP, which counters the negative biochemical and behavioral effects of stress-induced brain hormones Corticotropin Releasing Factor and Arginine-Vasopressin. Among its benefits is the reduction of excessive circulating levels of cortisol often associated with various stressors.
關於 PT00114：
PT00114 是一種 41 氨基酸殘留的合成肽，有望成爲嚴重神經精神疾病（包括抑鬱、焦慮和創傷後應激障礙）的新療法。它是天然存在的大腦肽 TCAP 的合成形式，可抵消壓力誘導的大腦激素促腎上腺激素促腎上腺皮質激素釋放因子和精氨酸加壓素的負面生化和行爲影響。它的好處之一是降低了皮質醇的過高循環水平，通常與各種壓力有關。
Forward-Looking Statements:
This press release contains forward-looking statements concerning Protagenic Therapeutics' product candidates and clinical trial plans. These statements are subject to various risks and uncertainties. Investors are urged to exercise caution and not place undue reliance on these forward-looking statements.
前瞻性陳述：
本新聞稿包含有關Protagenic Therapeutics候選產品和臨床試驗計劃的前瞻性陳述。這些陳述受各種風險和不確定性的影響。敦促投資者謹慎行事，不要過分依賴這些前瞻性陳述。
Company Contact:
Alexander K. Arrow, MD, CFA
Chief Financial Officer
Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010. Tel: 213-260-4342
Email: alex.arrow@protagenic.com
公司聯繫人：
亞歷山大·阿羅，醫學博士，特許金融分析師
首席財務官
Protagenic Therapeutics, Inc. 第五大道 149 號，套房 500，紐約，紐約州 10010。電話：213-260-4342
電子郵件：alex.arrow@protagenic.com
Investor Relations Contact:
Kirin M. Smith, President, PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022. Tel: 646-823-8656 Email: ksmith@pcgadvisory.com
投資者關係聯繫人：
Kirin M. Smith，PCG Advisory, Inc. 總裁。第三大道950號，套房 #2700，紐約，紐約州，10022。電話：646-823-8656 電子郵件：ksmith@pcgadvisory.com
SOURCE: Protagenic Therapeutics, Inc.
來源：Protagenic Therapeutics, Inc.