Upstream Bio Announces First Patient Dosed in Phase 2 Clinical Trial of Verekitug in Chronic Obstructive Pulmonary Disease (COPD)
Upstream Bio (NASDAQ:UPB) has initiated dosing in its Phase 2 clinical trial, VENTURE, evaluating verekitug for Chronic Obstructive Pulmonary Disease (COPD). The trial will assess approximately 670 adults with moderate-to-severe COPD, testing doses of 100 mg every 12 weeks or 400 mg every 24 weeks versus placebo.
This expansion marks verekitug's third indication in development, alongside ongoing Phase 2 trials in chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma. The company has completed enrollment for both existing trials, with data expected in Q3 2025 for CRSwNP and Q1 2026 for severe asthma.
Verekitug, as the only known biologic targeting the TSLP receptor, aims to improve COPD treatment through less frequent dosing and potentially differentiated efficacy compared to existing biologics.
Upstream Bio (NASDAQ:UPB) ha iniziato la somministrazione nella sua sperimentazione clinica di Fase 2, VENTURE, che valuta verekitug per la BroncoPneumopatia Cronica Ostruttiva (BPCO). Lo studio coinvolgerà circa 670 adulti con BPCO da moderata a grave, testando dosi di 100 mg ogni 12 settimane o 400 mg ogni 24 settimane rispetto al placebo.
Questa espansione rappresenta la terza indicazione in sviluppo per verekitug, insieme agli studi di Fase 2 in corso per la rinosinusite cronica con polipi nasali (CRSwNP) e l’asma grave. L’azienda ha completato il reclutamento per entrambi gli studi esistenti, con dati attesi nel terzo trimestre 2025 per CRSwNP e nel primo trimestre 2026 per l’asma grave.
Verekitug, unico biologico noto che mira al recettore TSLP, punta a migliorare il trattamento della BPCO offrendo dosaggi meno frequenti e potenzialmente un’efficacia differenziata rispetto ai biologici attualmente disponibili.
Upstream Bio (NASDAQ:UPB) ha iniciado la dosificación en su ensayo clínico de Fase 2, VENTURE, que evalúa verekitug para la Enfermedad Pulmonar Obstructiva Crónica (EPOC). El ensayo incluirá aproximadamente a 670 adultos con EPOC de moderada a grave, probando dosis de 100 mg cada 12 semanas o 400 mg cada 24 semanas frente a placebo.
Esta expansión representa la tercera indicación en desarrollo para verekitug, junto con los ensayos de Fase 2 en curso para rinosinusitis crónica con pólipos nasales (CRSwNP) y asma grave. La empresa ha completado la inscripción para ambos estudios existentes, con datos esperados en el tercer trimestre de 2025 para CRSwNP y en el primer trimestre de 2026 para asma grave.
Verekitug, el único biológico conocido que se dirige al receptor TSLP, busca mejorar el tratamiento de la EPOC mediante una dosificación menos frecuente y una posible eficacia diferenciada en comparación con los biológicos existentes.
Upstream Bio (NASDAQ:UPB)가 만성 폐쇄성 폐질환(COPD) 치료제인 verekitug의 2상 임상시험 VENTURE의 투약을 시작했습니다. 이 임상시험은 중등도에서 중증 COPD 환자 약 670명을 대상으로 12주마다 100mg 또는 24주마다 400mg 용량을 위약과 비교 평가할 예정입니다.
이번 확장은 verekitug의 세 번째 적응증 개발을 의미하며, 현재 만성 비부비동염 동반 비강 폴립(CRSwNP)과 중증 천식을 대상으로 한 2상 임상도 진행 중입니다. 두 기존 임상시험 모두 환자 모집을 완료했으며, CRSwNP는 2025년 3분기, 중증 천식은 2026년 1분기에 데이터가 발표될 예정입니다.
TSLP 수용체를 표적으로 하는 유일한 생물학적 제제인 verekitug은 투약 간격을 줄이고 기존 생물학적 제제와 차별화된 효능을 제공해 COPD 치료를 개선하는 것을 목표로 합니다.
Upstream Bio (NASDAQ:UPB) a débuté l'administration dans son essai clinique de phase 2, VENTURE, qui évalue verekitug pour la maladie pulmonaire obstructive chronique (MPOC). L'essai portera sur environ 670 adultes atteints de MPOC modérée à sévère, testant des doses de 100 mg toutes les 12 semaines ou 400 mg toutes les 24 semaines contre placebo.
Cette extension marque la troisième indication en développement pour verekitug, parallèlement aux essais de phase 2 en cours dans la rhinosinusite chronique avec polypes nasaux (CRSwNP) et l'asthme sévère. L'entreprise a terminé le recrutement pour les deux essais existants, avec des données attendues au troisième trimestre 2025 pour CRSwNP et au premier trimestre 2026 pour l'asthme sévère.
Verekitug, le seul biologique connu ciblant le récepteur TSLP, vise à améliorer le traitement de la MPOC grâce à une administration moins fréquente et potentiellement une efficacité différenciée par rapport aux biologiques existants.
Upstream Bio (NASDAQ:UPB) hat mit der Dosierung in seiner Phase-2-Studie VENTURE begonnen, in der verekitug zur Behandlung der chronisch obstruktiven Lungenerkrankung (COPD) untersucht wird. Die Studie wird etwa 670 Erwachsene mit mittelschwerer bis schwerer COPD einschließen und Dosierungen von 100 mg alle 12 Wochen oder 400 mg alle 24 Wochen gegen Placebo testen.
Diese Erweiterung stellt die dritte Indikation in der Entwicklung für verekitug dar, neben laufenden Phase-2-Studien bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) und schwerem Asthma. Das Unternehmen hat die Rekrutierung für beide bestehenden Studien abgeschlossen, mit erwarteten Daten im dritten Quartal 2025 für CRSwNP und im ersten Quartal 2026 für schweres Asthma.
Verekitug, das einzige bekannte Biologikum, das den TSLP-Rezeptor gezielt angreift, zielt darauf ab, die COPD-Behandlung durch selteneres Dosieren und möglicherweise differenzierte Wirksamkeit im Vergleich zu bestehenden Biologika zu verbessern.
- First patient dosed in Phase 2 COPD trial, expanding verekitug into third indication
- Large trial size with 670 participants indicates robust study design
- Completed enrollment in two other Phase 2 trials (CRSwNP and severe asthma)
- Unique mechanism as only known biologic targeting TSLP receptor
- Potential for differentiated dosing schedule (12 or 24 weeks) versus current treatments
- Long trial duration (60-108 weeks) means extended timeline to results
- Multiple concurrent Phase 2 trials may strain company resources
- No efficacy data available yet in any indication
Insights
Upstream Bio's verekitug enters Phase 2 testing for COPD, expanding to third indication with potential for less frequent dosing.
Upstream Bio's announcement marks a significant expansion of their clinical program for verekitug into COPD, following ongoing trials in chronic rhinosinusitis with nasal polyps (CRSwNP) and severe asthma. Verekitug's mechanism of action—antagonizing the TSLP receptor—targets a pathway increasingly recognized as important in COPD pathobiology, particularly in driving exacerbations that significantly impact patient outcomes and healthcare utilization.
The VENTURE trial design is robust, with approximately 670 adult participants and treatment durations extending from 60 to 108 weeks. The study will test two dosing regimens: 100mg every 12 weeks or 400mg every 24 weeks, potentially offering substantial advantages over current biologics that typically require monthly administration. The trial's primary endpoint—reduction in annual moderate or severe COPD exacerbations—directly addresses a critical clinical need, as exacerbations drive disease progression and mortality.
Notably, the trial design includes patients regardless of blood eosinophil count, though the primary analysis will focus on those with elevated eosinophils. This approach recognizes the heterogeneity of COPD while allowing for exploratory analyses in broader populations. The inclusion of patient-reported outcome measures alongside objective lung function assessments like FEV₁ provides a comprehensive evaluation framework.
The company appears to be positioning this trial for potential regulatory submission, suggesting confidence in verekitug's mechanism. With enrollment completed in their asthma and CRSwNP trials and data expected in Q3 2025 and Q1 2026 respectively, Upstream Bio is building a substantial respiratory disease portfolio targeting the TSLP pathway across multiple conditions with significant unmet needs.
– Global Phase 2 clinical trial, VENTURE, to evaluate the efficacy and safety of verekitug administered every 12 or 24 weeks in moderate-to-severe COPD –
– Broadens global development program for verekitug into third indication, strengthening pipeline across severe respiratory diseases including chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and COPD –
– Program updates also include completion of enrollment in Phase 2 clinical trial in severe asthma; top-line data now expected in first quarter of 2026 –
WALTHAM, Mass., July 08, 2025 (GLOBE NEWSWIRE) -- Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today announced that the first patient has been dosed in the Company’s Phase 2 clinical trial evaluating verekitug in patients with COPD, broadening the global development program for verekitug into a third indication.
Verekitug is a novel antibody antagonist of the Thymic Stromal Lymphopoietin (TSLP) receptor, a key driver of the inflammatory response in allergic and inflammatory diseases such as asthma, where agents targeting TSLP have demonstrated clinical benefits.
“We are excited to expand our clinical program for verekitug into COPD with the initiation of this clinical trial,” said Aaron Deykin, MD, Chief Medical Officer and head of research & development at Upstream Bio. “There are emerging data indicating that TSLP plays an important role in driving the pathobiology of COPD and the exacerbations that many patients with this disease experience. Given the results observed in our preclinical and early clinical studies in asthma, we believe that as the only known biologic in development targeting the TSLP receptor, verekitug may have the potential to advance COPD treatment with less frequent dosing and differentiated efficacy as compared to currently approved biologic therapies for this condition. This trial reflects our broader strategy to develop verekitug across multiple respiratory diseases.”
VENTURE (NCT06981078) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of verekitug in approximately 670 adults with moderate-to-severe COPD. Participants will be randomized to receive verekitug at doses of 100 mg once every 12 weeks, 400 mg once every 24 weeks, or placebo, over treatment periods of between 60 weeks and up to 108 weeks.
The primary endpoint of the study is the annualized rate of moderate or severe COPD exacerbations. Secondary endpoints include changes in participants’ day-to-day symptoms as well as measures of lung function, such as forced expiratory volume in one second (FEV₁). Upstream Bio has designed this trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval. The trial is enrolling patients regardless of blood eosinophil count, with the primary analysis focusing on those with elevated eosinophils at screening. Patients without elevated eosinophils at screening will be included to facilitate exploratory analyses of verekitug’s efficacy in this population.
This COPD trial is part of the broader development program for verekitug that includes separate ongoing Phase 2 studies in CRSwNP and severe asthma. Upstream Bio completed enrollment in the Phase 2 trials in CRSwNP in January 2025 and in severe asthma in June 2025 and expects top-line data readouts in the third quarter of 2025 and the first quarter of 2026, respectively.
For more information on the VENTURE Phase 2 clinical trial in COPD, visit the study listing at ClinicalTrials.gov.
About TSLP and TSLPR Blockade
Thymic Stromal Lymphopoietin (TSLP) is a cytokine that is a key driver of the inflammatory response in major allergic and inflammatory diseases, such as asthma, where disruption of TSLP signaling has been clinically validated as an effective therapeutic strategy.
TSLP activation is one of the first events in the inflammatory cascade stimulated by allergens, viruses and other triggers, initiating the activation of downstream targets such as IL-4, IL-5, IL-13, IL-17 and IgE.
Because TSLP is a target upstream in the inflammatory cascade, blocking the TSLP receptor (TSLPR) presents an opportunity for a single treatment to impact the drivers of multiple pathological inflammatory processes across a broad set of diseases.
About Verekitug
Verekitug is a novel recombinant fully human immunoglobulin G1 (IgG1) monoclonal antibody that binds to the TSLP receptor and inhibits proinflammatory signaling initiated by TSLP. It is the only known monoclonal antibody currently in clinical development that targets and inhibits the TSLP receptor. Verekitug is currently being evaluated in three separate global, placebo-controlled, randomized Phase 2 clinical trials: the VIBRANT trial (NCT06164704) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), the VALIANT trial (NCT06196879) in patients with severe asthma, and the VENTURE trial (NCT06981078) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Additionally, in May 2025, Upstream Bio initiated the VALOUR trial (NCT06966479), a long-term extension study in certain adult patients with severe asthma who completed the VALIANT Phase 2 clinical trial.
In preclinical studies, verekitug demonstrated high occupancy of the TSLP receptor and potent inhibition of TSLP signaling. Additionally, verekitug inhibited cytokine production from both CD4+ T cells and ILC2 cells and completely suppressed skin allergic reactions in a non-human primate model, suggesting that it may be effective against multiple types of inflammation.
Three clinical trials have been completed for verekitug, including a Phase 1 single-ascending dose (SAD) clinical trial and a Phase 1b multiple-ascending dose (MAD) clinical trial. In these trials, verekitug was well tolerated, had no clinically meaningful immunogenicity, and showed a predictable and consistent pharmacokinetic profile and high subcutaneous bioavailability. In patients with asthma, verekitug led to >
About COPD
COPD is a chronic inflammatory disease of the airways, associated with airflow worsening and episodic exacerbations that drive morbidity and mortality. Chronic inflammation causes structural changes within the lungs, narrowing already small airways and damaging lung tissue, which causes air sacs to lose functionality.
With COPD, everyday activities may result in shortness of breath and frequent exacerbations, which can result in hospitalization and drive health care utilization. People with COPD are also more likely to acquire lung infections like bronchitis and pneumonia.
COPD is the fourth leading cause of death worldwide, causing approximately 3.5 million deaths in 2021. Almost 14.2 million Americans in 2021, or
Published research has shown that IL-4, IL-5, and IL-13, cytokines in the type 2 inflammation pathway, may play a role in COPD pathogenesis. Elevated levels of TSLP have been found in the airways of people with COPD, and TSLP receptor expression was highest in patients with severe COPD compared to healthy controls. Environmental triggers can also increase TSLP expression in epithelial cells, suggesting a potential role of TSLP in COPD exacerbations.
Currently available treatments for COPD include inhaled steroids to reduce airway inflammation and bronchodilator inhalers to improve airflow. Oxygen and surgery may also be used for some patients with severe COPD. Similar to asthma and CRSwNP, biologics are emerging as new and potentially transformative treatments.
About Upstream Bio
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. The Company is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. The Company has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the global development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials; expectations for future discussions with regulatory authorities and the potential of the endpoints of the Company’s clinical trials to produce data that could support submissions for product approval; expectations for the size and growth potential of the market for verekitug in COPD and the Company’s ability to serve that market; and expectations regarding the differentiation, safety, efficacy, tolerability, and extended dosing interval of verekitug. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream Bio’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the initiation, timing, progress and results of clinical trials; Upstream Bio’s ability to fund its development activities and achieve development goals; Upstream Bio’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream Bio’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream Bio’s competitors and industry; and other risks and uncertainties described in greater detail under the caption “Risk Factors” in Upstream Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the SEC. Any forward-looking statements represent Upstream Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Upstream Bio explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Investor and Media Contact:
Meggan Buckwell
Director, Corporate Communications and Investor Relations
ir@upstreambio.com
FAQ
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