Protagenic Therapeutics Advances PT00114 into Multiple-Dose Phase 1 Trial; Positioning for Phase 2 in Stress & Mood Disorders
Protagenic Therapeutics (NASDAQ:PTIX) has announced significant progress in the clinical development of PT00114, its novel neuro-active peptide therapy. The company has completed first dose injection for all subjects in the multiple-dose portion of its Phase 1 trial, with full dosing completion expected by August end 2025.
PT00114 is pioneering as the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a natural brain hormone that regulates stress and emotional balance. The drug targets the amygdala and hippocampus, offering a differentiated approach to treating anxiety, depression, addiction, and PTSD.
Following successful completion of a single ascending dose trial demonstrating favorable safety, the company anticipates topline safety data by September 2025 and plans to advance to Phase 2 efficacy studies in Q1 2026.
Protagenic Therapeutics (NASDAQ:PTIX) ha annunciato progressi rilevanti nello sviluppo clinico di PT00114, il suo nuovo peptide neuroattivo. La società ha somministrato la prima dose a tutti i soggetti nella parte a dosi multiple dello studio di Fase 1 e prevede di completare tutte le somministrazioni entro la fine di agosto 2025.
PT00114 è il primo farmaco sperimentale basato sul Teneurin C-terminus Associated Peptide (TCAP), un ormone cerebrale naturale che regola lo stress e l’equilibrio emotivo. Il trattamento è mirato all’amigdala e all’ippocampo, proponendo un approccio differenziato per ansia, depressione, dipendenze e disturbo da stress post-traumatico.
Dopo il completamento con esito favorevole dello studio a dose singola, l’azienda prevede di riportare i dati principali di sicurezza entro settembre 2025 e intende passare agli studi di efficacia di Fase 2 nel primo trimestre 2026.
Protagenic Therapeutics (NASDAQ:PTIX) ha anunciado avances importantes en el desarrollo clínico de PT00114, su novedoso péptido neuroactivo. La compañía ha administrado la primera dosis a todos los sujetos en la parte de dosis múltiples de su ensayo de Fase 1 y espera completar la dosificación total para finales de agosto de 2025.
PT00114 es pionero como la primera terapia en investigación basada en Teneurin C-terminus Associated Peptide (TCAP), una hormona cerebral natural que regula el estrés y el equilibrio emocional. El fármaco actúa sobre la amígdala y el hipocampo, ofreciendo un enfoque diferenciado para tratar la ansiedad, la depresión, la adicción y el TEPT.
Tras completar con éxito el ensayo de dosis única que mostró un perfil de seguridad favorable, la empresa anticipa los datos principales de seguridad para septiembre de 2025 y planea avanzar a los estudios de eficacia de Fase 2 en el primer trimestre de 2026.
Protagenic Therapeutics (NASDAQ:PTIX)는 신경 활성 펩타이드 신약 PT00114의 임상 개발에서 중요한 진전을 발표했습니다. 회사는 1상 다회 투여 구간의 모든 피험자에 대해 최초 투여를 완료했으며, 전체 투여는 2025년 8월 말까지 완료될 예정입니다.
PT00114은 스트레스와 정서적 균형을 조절하는 천연 뇌 호르몬인 Teneurin C-terminus Associated Peptide (TCAP)를 기반으로 한 최초의 치료 후보로 선구적입니다. 이 약물은 편도체와 해마를 표적으로 하며 불안, 우울증, 중독 및 외상 후 스트레스 장애(PTSD)에 대해 차별화된 접근을 제공합니다.
단회 증가 용량 시험에서 유리한 안전성을 보인 후, 회사는 주요 안전성 데이터가 2025년 9월까지 발표될 것으로 기대하며, 2026년 1분기에 2상 효능 시험으로 진행할 계획입니다.
Protagenic Therapeutics (NASDAQ:PTIX) a annoncé des progrès significatifs dans le développement clinique de PT00114, son nouveau peptide neuroactif. La société a réalisé la première injection chez tous les sujets de la partie à doses multiples de son essai de phase 1 et prévoit d’avoir terminé l’ensemble des administrations d’ici fin août 2025.
PT00114 est pionnier en tant que premier candidat thérapeutique basé sur le Teneurin C-terminus Associated Peptide (TCAP), une hormone cérébrale naturelle qui régule le stress et l’équilibre émotionnel. Le médicament cible l’amygdale et l’hippocampe, offrant une approche différenciée pour traiter l’anxiété, la dépression, les addictions et le SSPT.
Après l’achèvement réussi d’un essai à dose unique montrant une sécurité favorable, la société anticipe des données principales de sécurité d’ici septembre 2025 et prévoit de passer aux études d’efficacité de phase 2 au 1er trimestre 2026.
Protagenic Therapeutics (NASDAQ:PTIX) hat bedeutende Fortschritte in der klinischen Entwicklung von PT00114, seinem neuartigen neuroaktiven Peptidtherapeutikum, bekanntgegeben. Das Unternehmen hat die Erstinjektion bei allen Studienteilnehmern im Mehrfachdosis-Teil der Phase‑1‑Studie abgeschlossen und rechnet damit, die komplette Dosierung bis Ende August 2025 abzuschließen.
PT00114 ist wegweisend als erste Prüfsubstanz auf Basis des Teneurin C-terminus Associated Peptide (TCAP), eines natürlichen Gehirnhormons, das Stress und emotionale Balance reguliert. Das Medikament zielt auf Amygdala und Hippocampus ab und bietet einen differenzierten Ansatz zur Behandlung von Angststörungen, Depressionen, Abhängigkeit und PTBS.
Nach dem erfolgreichen Abschluss einer Einzeldosis‑Aufstiegsstudie mit günstigem Sicherheitsprofil erwartet das Unternehmen die Topline‑Sicherheitsdaten bis September 2025 und plant, im 1. Quartal 2026 in Phase‑2‑Wirkungsstudien überzugehen.
- Successful completion of first dose injection for all study subjects in Phase 1 multiple-dose trial
- Previous single ascending dose trial confirmed favorable safety and tolerability profile
- Novel mechanism of action targeting natural brain hormone TCAP, offering potential advantage over existing treatments
- Clear development timeline with Phase 2 trials planned for Q1 2026
- Current market treatments leave more than 50% of patients without adequate relief
- Phase 2 efficacy data still needed to demonstrate therapeutic potential
- Complex clinical development pathway for novel mechanism of action drug
Insights
Protagenic's PT00114 advances to multiple-dose Phase 1 trial with unique stress-modulating mechanism, positioning for Phase 2 in 2026.
The advancement of PT00114 into a multiple-dose Phase 1 trial represents a significant milestone in Protagenic's clinical development program. This peptide therapy is particularly noteworthy for its novel mechanism of action targeting Teneurin C-terminus Associated Peptide (TCAP)—a naturally occurring brain hormone concentrated in the amygdala and hippocampus, regions critical for emotional processing and stress response.
What makes PT00114 potentially revolutionary is its approach to modulating maladaptive stress responses rather than simply blunting symptoms, as current therapies do. This mechanistic distinction could address a substantial unmet need, considering that more than half of patients using existing treatments for anxiety, depression, PTSD, and addiction don't achieve adequate relief.
The company's timeline indicates rapid progression, with dosing completion expected by end of August, topline safety data by end of September, and Phase 2 initiation in Q1 2026. This accelerated timeline suggests confidence in the drug's safety profile, likely supported by positive results from their previous single ascending dose trial.
For a small-cap biopharmaceutical company, this progress in developing a novel neuroactive peptide with potential applications across multiple high-prevalence conditions (anxiety, depression, PTSD, addiction) represents a crucial value-creation milestone. The completion of Phase 1 and advancement to proof-of-concept Phase 2 studies typically triggers significant clinical validation and potential partnership opportunities in the neuropharmaceutical space.
Dosing Completion Expected by End of August; Phase 2 Trial Expected to Begin in 1Q 2026
NEW YORK, NY / ACCESS Newswire / August 21, 2025 / Protagenic Therapeutics, Inc. (NASDAQ:PTIX), a biopharmaceutical company developing novel neuro-active peptide therapies, today announced completion of first dose injection for all study subjects in the multiple-dose portion of its ongoing Phase I clinical trial of PT00114. The company expects to complete dosing by the end of August, with topline safety data anticipated by the end of September, supporting advancement into Phase 2 efficacy studies planned for the first quarter of 2026.
PT00114 is the first investigational therapy based on Teneurin C-terminus Associated Peptide (TCAP), a naturally occurring brain hormone localized in the amygdala and hippocampus that regulates stress and emotional balance. Unlike existing therapies that blunt symptoms, PT00114 is thought to directly modulate the brain's maladaptive responses to stress-offering a differentiated approach to treating anxiety, depression, addiction, and Post Traumatic Stress Disorder (PTSD).
Current treatments leave more than half of patients without adequate relief and are burdened by significant side effects.
"Initiating the multiple-dose trial of PT00114 marks a pivotal step in our clinical program," said Robert Stein, M.D., Ph.D., Chief Medical Officer. "With dosing on track to complete this month, we are preparing to transition rapidly into Phase 2 efficacy trials."
The multiple-dose study follows a successful single ascending dose trial that confirmed PT00114's favorable safety and tolerability profile. Data from this trial will contribute to Phase 2 studies designed to demonstrate PT00114's therapeutic potential in stress-related and mood disorders.
About Protagenic Therapeutics, Inc.:
Protagenic Therapeutics, Inc. (NASDAQ:PTIX) is committed to pioneering neuro-active peptides into therapeutics to mitigate stress-related disorders. For more information, visit www.protagenic.com.
About PT00114:
PT00114, a 41-amino-acid synthetic peptide, holds promise in treating various neuro-psychiatric conditions, including depression, anxiety, and PTSD. It operates with a novel mechanism, mirroring the active part of the natural brain hormone TCAP, thereby reducing circulating cortisol levels.
Forward-Looking Statements:
This press release contains forward-looking statements concerning Protagenic Therapeutics' product candidates and clinical trial plans. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. Investors are urged to exercise caution and not place undue reliance on such statements, because they are subject to risks and uncertainties that could cause actual results to differ materially.
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
SOURCE: Protagenic Therapeutics, Inc.
View the original press release on ACCESS Newswire
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