Eupraxia Pharmaceuticals Announces Positive Data from Fifth Cohort of RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) announced positive data from the fifth cohort of its RESOLVE Phase 1b/2a trial for EP-104GI in treating Eosinophilic Esophagitis (EoE). Key highlights include: one patient achieving complete histological remission at 12 weeks, consistent improvement in patient-reported outcomes, and the largest average reduction in symptom scores observed in the fourth cohort at 24 weeks. The fifth cohort showed the greatest percentage change in histology scores to date, with clear dose response across Cohorts 3 to 5. No serious adverse events were reported, and Cohort 6 is fully enrolled with data expected in Q1 2025.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) ha annunciato dati positivi dal quinto gruppo del suo trial RESOLVE di fase 1b/2a per EP-104GI nel trattamento dell'Esofagite Eosinofila (EoE). I principali punti salienti includono: un paziente che ha raggiunto una remissione istologica completa a 12 settimane, un miglioramento costante negli esiti riportati dai pazienti e la maggiore riduzione media dei punteggi dei sintomi osservata nel quarto gruppo a 24 settimane. Il quinto gruppo ha mostrato il maggiore cambiamento percentuale nei punteggi istologici fino ad oggi, con una chiara risposta alla dose nei gruppi da 3 a 5. Non sono stati segnalati eventi avversi gravi e il sesto gruppo è completamente arruolato, con dati attesi nel primo trimestre del 2025.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) anunció datos positivos del quinto grupo de su ensayo RESOLVE de fase 1b/2a para EP-104GI en el tratamiento de la Esofagitis Eosinofílica (EoE). Los aspectos más destacados incluyen: un paciente que logró una remisión histológica completa a las 12 semanas, una mejora consistente en los resultados reportados por los pacientes y la mayor reducción promedio en los puntajes de síntomas observada en el cuarto grupo a las 24 semanas. El quinto grupo mostró el mayor cambio porcentual en los puntajes histológicos hasta la fecha, con una clara respuesta a la dosis en los grupos 3 a 5. No se informaron eventos adversos graves y el grupo 6 está completamente inscrito, con datos esperados en el primer trimestre de 2025.
유프락시아 제약 (TSX/NASDAQ: EPRX)은 EoE(호산구 식도염) 치료를 위한 EP-104GI의 RESOLVE 1b/2a 임상시험의 다섯 번째 코호트에서 긍정적인 데이터를 발표했습니다. 주요 사항으로는: 12주째 완전한 조직학적 관해를 달성한 환자 1명, 환자가 보고한 결과의 지속적인 개선, 그리고 24주째 네 번째 코호트에서 관찰된 증상 점수의 가장 큰 평균 감소가 포함됩니다. 다섯 번째 코호트는 지금까지의 조직학적 점수의 가장 큰 백분율 변화를 보였으며, 3코호트에서 5코호트까지 명확한 용량 반응이 있었습니다. 심각한 이상 반응은 보고되지 않았고, 6코호트는 완전히 등록되어 있으며, 2025년 1분기에 데이터가 예상됩니다.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) a annoncé des données positives de la cinquième cohorte de son essai RESOLVE de phase 1b/2a pour EP-104GI dans le traitement de l’œsophagite éosinophile (EoE). Les faits saillants comprennent : un patient atteignant une rémission histologique complète à 12 semaines, une amélioration constante des résultats rapportés par les patients et la plus grande réduction moyenne des scores de symptômes observée dans la quatrième cohorte à 24 semaines. La cinquième cohorte a montré le plus grand changement en pourcentage dans les scores histologiques à ce jour, avec une réponse claire à la dose à travers les cohortes 3 à 5. Aucun événement indésirable grave n'a été signalé, et la cohorte 6 est complètement inscrite, avec des données attendues au premier trimestre de 2025.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) gab positive Daten aus der fünften Kohorte seiner RESOLVE Phase 1b/2a-Studie für EP-104GI zur Behandlung der eosinophilen Ösophagitis (EoE) bekannt. Zu den wichtigsten Ergebnissen gehören: ein Patient, der nach 12 Wochen eine vollständige histologische Remission erreichte, eine kontinuierliche Verbesserung der vom Patienten berichteten Ergebnisse und der größte durchschnittliche Rückgang der Symptomwerte, der in der vierten Kohorte nach 24 Wochen beobachtet wurde. Die fünfte Kohorte zeigte die größte prozentuale Veränderung der histologischen Werte bisher, mit einer klaren Dosisreaktion über die Kohorten 3 bis 5. Es wurden keine schwerwiegenden unerwünschten Ereignisse gemeldet, und die Kohorte 6 ist vollständig rekrutiert, wobei die Daten für das erste Quartal 2025 erwartet werden.
- One patient achieved complete histological remission in Cohort 5
- 83% mean reduction in Peak Eosinophil Counts at 12 weeks in Cohort 5
- 100% peak reduction in Stage and Grade scores in Cohort 5
- 41% mean reduction in symptom scores at 12 weeks in Cohort 5
- Clear dose response showing improved efficacy with higher doses
- No serious adverse events reported across all cohorts
- Only one out of three patients achieved complete histological remission in Cohort 5
Insights
The Phase 1b/2a RESOLVE trial data for EP-104GI shows promising clinical efficacy in treating Eosinophilic Esophagitis. Key highlights include complete histological remission in one patient and significant improvements across multiple endpoints in Cohort 5:
- An impressive
83% mean reduction in Peak Eosinophil Counts at 12 weeks 54% reduction in EoEHSS Composite scores41% improvement in patient-reported dysphagia symptoms
The dose-response relationship observed across Cohorts 3-5 suggests optimal dosing hasn't yet been reached, while maintaining a strong safety profile with no serious adverse events. With 450,000+ EoE patients in the US and treatment options, EP-104GI's targeted delivery approach could represent a significant advancement in EoE therapy.
- One of three patients in Cohort 5 achieved complete histological remission at 12 weeks.
- Consistent improvement in patient-reported outcomes with six of six evaluable patients in the fourth and fifth cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks.
- At 24 weeks, the fourth cohort experienced the largest average reduction in SDI scores of all cohorts to date.
- The fifth cohort continued to show improved patient outcomes with the greatest percentage change in histology (EoEHSS2) scores of any cohort to date.
- Both the mean reduction in Peak Eosinophil Counts (PEC3)at four biopsy sites and the percent change in histology (EoEHSS2) scores showed a clear dose response across Cohorts 3 to 5, with Cohort 5 showing the greatest response. No serious adverse events reported in any of the five cohorts to date.
- Cohort 6 is now fully enrolled and dosed, with 12-week data anticipated in Q1 2025.
New Clinical Data from the Fifth Cohort of the RESOLVE Trial
The results announced today from the fifth cohort of the RESOLVE trial, for treatment of EoE, are derived from 12, 4 mg injections of EP-104GI (total dose of 48 mg) administered to the lower two-thirds of each patient's esophagus. The data show:
- One patient achieved complete histological remission, defined by the presence of fewer than six eosinophils per high-powered field on esophageal biopsy.
- Straumann Dysphagia Index ("SDI")1, a patient-reported outcome measure designed to assess symptom severity, was lower for all three patients post-administration with peak reductions up to 3 points (
50% from baseline). At 12 weeks post-administration, mean SDI reduction was41% or 2.3 points. - Eosinophilic Esophagitis Histology Scoring System ("EoEHSS")2 scores, which evaluate the severity and extent of EoE, showed the largest percent reduction of any cohort to date at 12 weeks, with peak reduction of
100% in Stage and Grade scores, and a mean54% reduction in Composite Stage and Grade scores. - Using data from four biopsy sites, which is consistent with the
U.S. Food and Drug Administration ("FDA") Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in Peak Eosinophil Counts ("PEC")3 was83% at 12 weeks.
Plasma fluticasone levels continue to be predictable and well-below published levels of daily fluticasone asthma treatments. "As the RESOLVE trial advances, we are observing increasingly positive data on efficacy and safety outcomes, including no adverse events such as candidiasis, adrenal suppression or glucose derangement," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "Notably, higher dosing levels are yielding improved patient responses, such as histological remission, enhanced patient-reported symptom scores, and favourable histology results, all without reaching a maximum tolerated dose thus far."
The RESOLVE trial is a Phase 1b/2a, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. EP-104GI is administered as a single dose via four to 20 injections into a patient's esophageal wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts have been assessed for up to 24 weeks. Patients in cohorts five and above will be assessed for 52 weeks.
The Company intends to continue to periodically disclose additional data from the trial.
New Clinical Data from the Fourth Cohort in the RESOLVE Trial
The results announced today from the fourth cohort of the RESOLVE trial in EoE, are derived from 12, 2.5 mg injections of EP-104GI (total dose of 30 mg) administered to a portion of each patient's lower esophagus. The data show:
- SDI1 scores continued to improve out to 24 weeks (average four-point reduction), showing the largest reduction in scores for any cohort to date at this time point.
- EoEHSS2 Composite Stage and Composite Grade scores were both lower than baseline at 12 weeks post-administration, showing an average reduction of
39% and37% , respectively. - Using data from four biopsy sites, which is consistent with the FDA Guidance for Developing Drugs for the Treatment of EoE, the mean reduction in PEC3 was
67% at 12 weeks. This compares favourably with55% mean reduction in PEC in cohort 3.
Notes
- Straumann Dysphagia Index, or SDI, is a patient-reported outcome score that uses a seven-day recall measuring dysphagia (trouble swallowing) severity and frequency. A reduction in SDI is a positive outcome for the RESOLVE trial.
- In the Eosinophilic Esophagitis Histology Scoring System, or EoEHSS, grade indicates the severity of each of the eight histologic features assessed by the EoEHSS while stage indicates their extent. For the RESOLVE trial, these features include inflammation, increased cell production in a normal tissue or organ, and fibrosis, also known as fibrotic scarring, and five other features. A reduction in EoEHSS is a positive outcome for the RESOLVE trial.
- Peak Eosinophil Counts, or PEC, means the peak number of eosinophils found in esophageal biopsies. Eosinophils are one of several white blood cells that support a person's immune system. A reduction in PEC is a positive outcome for the RESOLVE trial.
About EoE
EoE is an inflammatory-mediated disease in which white blood cells migrate into and become trapped in the esophagus, creating pain and difficulty with swallowing food. According to market research from Clearview Healthcare Partners, EoE affects more than 450,000 people in
About Eupraxia Pharmaceuticals Inc.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.
Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.
Notice Regarding Forward-looking Statements and Information
This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as "plans", "is expected", "expects", "suggests", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes", "potential" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the Company's product candidates, including their expected benefits to patients with respect to safety, tolerability, efficacy and duration; additional clinical data from the RESOLVE trial of EP-104GI in EoE, including the Company's intention to periodically disclose such data and timing thereof; the Company's expectations regarding dose-escalating cohorts; the results gathered from studies and trials of Eupraxia's product candidates; the potential for the Company's technology to impact the drug delivery process; potential market opportunity for the Company's products; and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company's ability to obtain positive results from the Company's research and development activities, including clinical trials; and the Company's ability to protect patents and proprietary rights. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company's limited operating history; the Company's novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the Company could lose license rights that are important to its business; the Company's current license agreement may not provide an adequate remedy for its breach by the licensor; the Company's technology may not be successful for its intended use; the Company's future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the Company's clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the Company completely relies on third parties to provide supplies and inputs required for its products and services; the Company relies on external contract research organizations to provide clinical and non-clinical research services; the Company may not be able to successfully execute its business strategy; the Company will require additional financing, which may not be available; any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company's ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company's operations; the Company's restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company's common share price; and other risks and uncertainties described in more detail in Eupraxia's public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.
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