Edesa Biotech Reports Positive Results in Phase 3 Respiratory Study
Edesa Biotech (Nasdaq: EDSA) reported positive Phase 3 results for paridiprubart (EB05) in Acute Respiratory Distress Syndrome (ARDS) on Oct 28, 2025. In the ITT population (n=104) paridiprubart plus standard of care reduced 28‑day mortality to 39% vs 52% for placebo (absolute improvement 13%, relative risk reduction 25%, p<0.001). At 60 days mortality was 46% vs 59% (absolute improvement 13%, relative reduction 22%, p=0.003). Paridiprubart also produced a 41% higher relative rate of clinical improvement at Day 28. Safety in a population >275 subjects was reported as generally well tolerated.
Edesa Biotech (Nasdaq: EDSA) ha riportato risultati positivi di fase 3 per paridiprubart (EB05) nella sindrome da distress respiratorio acuto (ARDS) il 28 ottobre 2025. Nella popolazione ITT (n=104) paridiprubart più terapia standard ha ridotto la mortalità a 28 giorni al 39% vs 52% per il placebo (miglioramento assoluto 13%, riduzione del rischio relativo 25%, p<0,001). A 60 giorni la mortalità era 46% vs 59% (miglioramento assoluto 13%, riduzione relativa 22%, p=0,003). Paridiprubart ha anche prodotto un 41% più alta velocità relativa di miglioramento clinico al Day 28. La sicurezza in una popolazione >275 soggetti è stata riportata come generalmente ben tollerata.
Edesa Biotech (Nasdaq: EDSA) informó resultados positivos de la fase 3 para paridiprubart (EB05) en el síndrome de dificultad respiratoria aguda (ARDS) el 28 de octubre de 2025. En la población ITT (n=104) paridiprubart más la atención estándar redujo la mortalidad a los 28 días a 39% frente a 52% para el placebo (mejora absoluta 13%, reducción del riesgo relativo 25%, p<0,001). A los 60 días la mortalidad fue 46% frente a 59% (mejora absoluta 13%, reducción relativa 22%, p=0,003). Paridiprubart también produjo una tasa de mejoría clínica relativa 41% mayor en el Day 28. La seguridad en una población de >275 sujetos se informó como generalmente bien tolerada.
Edesa Biotech (Nasdaq: EDSA)는 paridiprubart (EB05)가 급성 호흡곤란 증후군(ARDS)에서 3상 양성 결과를 2025년 10월 28일 발표했습니다. ITT 모집단(n=104)에서 paridiprubart와 표준 치료를 병용한 경우 28일 사망률이 39%로 감소했고, 위약(52%) 대비 절대 개선 13%, 상대 위험 감소 25%, p<0.001. 60일 사망률은 46% 대 59%로, 절대 개선 13%, 상대 감소 22%, p=0.003. 또한 Day 28에서 임상 개선의 상대 속도가 41% 더 높았습니다. >275명의 피험자 수에서의 안전성은 일반적으로 잘 견디는 것으로 보고되었습니다.
Edesa Biotech (Nasdaq : EDSA) a publié des résultats positifs de phase 3 pour le paridiprubart (EB05) dans le syndrome de détresse respiratoire aiguë (SDRA) le 28 octobre 2025. Dans la population ITT (n=104), le paridiprubart en association avec les soins standard a réduit la mortalité à 28 jours à 39% contre 52% pour le placebo (amélioration absolue 13%, réduction du risque relatif 25%, p<0,001). À 60 jours, la mortalité était 46% contre 59% (amélioration absolue 13%, réduction relative 22%, p=0,003). Le paridiprubart a également produit un taux d'amélioration clinique relatif de 41% plus élevé au Jour 28. La sécurité dans une population >275 sujets a été rapportée comme généralement bien tolérée.
Edesa Biotech (Nasdaq: EDSA) meldete positive Phase-3-Ergebnisse für paridiprubart (EB05) bei akutem respiratorischem Versagen (ARDS) am 28. Oktober 2025. In der ITT-Bevölkerung (n=104) reduzierte paridiprubart plus Standardversorgung die 28-Tage-Mortalität auf 39% gegenüber 52% für Placebo (absoluter Gewinn 13%, relatives Risiko-Rückgang 25%, p<0,001). Bei 60 Tagen betrug die Mortalität 46% vs 59% (absoluter Gewinn 13%, relativer Rückgang 22%, p=0,003). Paridiprubart erzielte auch eine 41%-höhere relative Rate klinischer Verbesserung am Tag 28. Die Sicherheit in einer Population >275 Probanden wurde allgemein gut verträglich gemeldet.
إيدا ساب Biotech (ناسداك: EDSA) أصدرت نتائج إيجابية للمرحلة الثالثة لـ paridiprubart (EB05) في متلازمة ضيق التنفس الحاد (ARDS) في 28 أكتوبر 2025. في سكان ITT (n=104)، خفض paridiprubart مع الرعاية القياسية معدل الوفيات عند 28 يوماً إلى 39% مقارنة بـ 52% للوهم (تحسن مطلق 13%، انخفاض في الخطر النسبي 25%، p<0.001). عند 60 يوماً كانت الوفيات 46% مقابل 59% (تحسن مطلق 13%، انخفاض نسبي 22%، p=0.003). كما حقق paridiprubart معدل تحسن سريري نسبي أعلى بنسبة 41% عند اليوم 28. تم الإبلاغ عن الأمان في مجموعة تزيد عن 275 مشاركاً بأنه بشكل عام مستدام بشكل جيد.
艾达莎生物科技（纳斯达克：EDSA） 于 2025 年 10 月 28 日公布了 paridiprubart (EB05) 在急性呼吸窘迫综合征（ARDS）中的三期积极结果。在 ITT 人群（n=104）中，paridiprubart 与标准治疗联合降低 28 天死亡率至 39%，相比安慰剂的 52%（绝对改善 13%，相对风险降低 25%，p<0.001）。在 60 天时死亡率为 46% 对 59%（绝对改善 13%，相对降低 22%，p=0.003）。Paridiprubart 在 Day 28 的临床改善相对速率也提高了 41%。在超过 275 名受试者的群体中安全性被报告为总体耐受良好。
- 28‑day mortality reduced to 39% vs 52% (absolute +13%)
- 25% relative reduction in 28‑day risk of death (ITT; p<0.001)
- 60‑day mortality improved by an absolute 13% with 22% RRR (p=0.003)
- 41% higher relative rate of clinical improvement at Day 28
- Safety reported as generally well tolerated in >275 subjects
- Efficacy ITT population was truncated at n=104 after early enrollment stop for business reasons
- Primary efficacy results derive from a relatively small randomized sample (104), limiting sample size
Insights
Phase 3 met primary and secondary endpoints; paridiprubart showed statistically significant mortality and clinical improvement in a truncated ITT cohort.
Paridiprubart produced a 13% absolute improvement in 28‑day survival (39% vs 52%) corresponding to a
The dataset was truncated by early enrollment discontinuation for business reasons; the efficacy ITT cohort is small (n=104) while the pooled safety population exceeds 275 subjects. Safety is described as "generally well‑tolerated" and consistent with prior experience, and the program is concurrently enrolled in the U.S. "Just Breathe" study and receives funding from the Government of Canada. These facts imply that regulatory review, full dataset disclosure, and confirmation in larger cohorts are the key dependencies for broader adoption.
Watch for full trial data release and regulatory filings after this
- Study met primary and secondary endpoints
- Paridiprubart demonstrated a relative reduction in the risk of death of
25% - Treatment provided patients with clinically meaningful improvement in survival and recovery
- Paridiprubart exhibited consistent safety and tolerability profile
TORONTO, Oct. 28, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics (HDTs) for immuno-inflammatory diseases, today announced positive results from a Phase 3 study evaluating the company’s drug candidate paridiprubart (EB05) as a treatment for Acute Respiratory Distress Syndrome (ARDS), a life-threatening form of respiratory failure.
The data from the Phase 3 study demonstrated that paridiprubart met primary and secondary endpoints with statistical significance. Paridiprubart led to a clinically significant reduction in mortality through 60 days, as well as a significant reduction in the proportion of patients requiring invasive mechanical ventilation (IMV).
Edesa reported that paridiprubart in the most conservative intention-to-treat (ITT) population met the primary endpoint, demonstrating a statistically significant and clinically meaningful benefit for reduced mortality at 28 days. Patients treated with paridiprubart plus standard of care treatments (SOC) had a lower risk of death (
The results from a safety population of more than 275 subjects, which included patients enrolled during the interim between the Phase 2 and Phase 3 study, demonstrated that EB05 was generally well-tolerated and consistent with the observed safety profile to date.
Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech, said the Phase 3 data further demonstrate the transformative potential of EB05 to improve survival and ICU hospitalization outcomes. “We are encouraged by these positive Phase 3 results, which demonstrated meaningful improvements in outcomes for patients. These data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluated. We believe that these findings not only provide important validation of our therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications as well.”
Paridiprubart is currently being evaluated in the U.S. government’s “Just Breathe” study investigating three novel threat-agnostic therapeutics in hospitalized adult patients with ARDS. Edesa’s paridiprubart development program, including this Phase 3 study and manufacturing scale-up, also receives funding from the Government of Canada’s Strategic Innovation Fund.
The study was managed and all analyses were conducted by JSS Medical Research, an international contract research organization.
Detailed Results
Patients were enrolled from 38 hospitals in the USA, Canada and Colombia. Participants were 18 years or older, receiving IMV with or without additional organ support at the time of hospitalization. They were randomly assigned (1:1) to SOC with paridiprubart (15mg/kg, maximum dose of 1400mg, n=56), or SOC with placebo (n=48). Efficacy outcomes were 28-day and 60-day mortality and proportion of patients with a decrease of ≥ 2 points in the WHO COVID-19 Severity Scale (WCSS) at 28-days. The company opted to discontinue enrollment early for business reasons.
Patient demographics and baseline disease parameters were similar for the two groups with overall mean (SD) age: 52 (20-86) years, female (
The following tables summarize the key results from the truncated Phase 3 study.
Mortality Rate at 28 Days and 60 Days
Multivariate Logistic Regression Derived Risk Differences,
| Timepoint | Paridiprubart | Placebo | P-Value** |
| 28-Day | 0.39 (0.35, 0.44) | 0.52 (0.47, 0.58) | <0.001 |
| 60-Day | 0.46 (0.42, 0.50) | 0.59 (0.55, 0.63) | 0.003 |
| Adjusted mortality risk estimate: variables included age, baseline WCSS, baseline antiviral use, baseline corticosteroid use, baseline immunomodulator use, concomitant antiviral use, concomitant corticosteroid use, concomitant immunomodulator use. Intent to treat (ITT) population; n=104. **P-value based on Wald test for parameter estimate. | |||
Achievement of ≥2-Point Improvement in WCSS at 28 Days
Multivariate Logistic Regression Derived Risk Differences,
| Paridiprubart | Placebo | P-Value** |
| 0.38 (0.31, 0.45) | 0.27 (0.21, 0.33) | 0.032 |
| Adjusted risk estimate: variables included age, baseline WCSS, baseline antiviral use, baseline corticosteroid use, baseline immunomodulator use, concomitant antiviral use, concomitant corticosteroid use, concomitant immunomodulator use. ITT population; n=104. **P-value based on Wald test for parameter estimate. | ||
About Paridiprubart
Paridiprubart represents a new class of host directed therapeutics (HDTs) that are designed to modulate the body's own immune response when confronted with known or unknown public health threats such as novel infectious diseases as well as chemical, biological, radiological, and nuclear incidents. Importantly, HDTs are agnostic to the causal agent and can be stockpiled preemptively to respond to public health emergencies and biodefense. Mechanistically, paridiprubart inhibits toll-like receptor 4 (TLR4), a key immune signaling protein that has been shown to be activated by viruses, bacteria, injury/trauma and in the pathogenesis of chronic autoimmune diseases.
About ARDS
Acute Respiratory Distress Syndrome involves an exaggerated immune response leading to inflammation and injury to the lungs that prevents the lungs from oxygenating blood and ultimately deprives the body of oxygen. For moderate to severe cases, there are currently few recommended treatments other than supplemental oxygen and mechanical ventilation, and mortality rates are high. In addition to virus-induced pneumonia, ARDS can be caused by smoke/chemical inhalation, sepsis, chest injury, and other causes. ARDS accounts for
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as a therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (
Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s belief that the Phase 3 data of EB05 presented herein demonstrate the transformative potential of EB05 to improve medical outcomes; the company’s belief that these results demonstrated meaningful improvements in outcomes for patients; the company’s belief that these data indicate that paridiprubart provided a consistent and durable effect in patients across all severity groups evaluate; the company’s belief that these findings not only provide important validation of its therapeutic approach but also support paridiprubart’s potential use as a standard of care treatment for ARDS, and potentially chronic respiratory indications; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.
Contact:
Gary Koppenjan
Edesa Biotech, Inc.
investors@edesabiotech.com
FAQ
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