Eupraxia Pharmaceuticals Announces Data from RESOLVE Phase 1b/2a Trial of EP-104GI for Treatment of Eosinophilic Esophagitis
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) announced positive data from its RESOLVE Phase 1b/2a trial of EP-104GI for treating eosinophilic esophagitis (EoE). Key findings include:
- 10 of 11 evaluable patients in the first four cohorts experienced reduced symptom scores at 12 weeks
- The fourth cohort showed the greatest percentage change in histology scores to date
- No serious adverse events reported across all four fully-dosed cohorts
The fourth cohort data showed:
- 45% mean reduction in symptom scores at 12 weeks
- 39% mean reduction in histology composite stage scores
- 67% mean reduction in peak eosinophil counts
These results are comparable to currently approved EoE therapies. The company remains optimistic about further improvements as the trial progresses towards optimal dosing.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) ha annunciato dati positivi dal suo trial RESOLVE di fase 1b/2a per EP-104GI per il trattamento dell'esofagite eosinofila (EoE). I risultati chiave includono:
- 10 dei 11 pazienti valutabili nei primi quattro gruppi hanno mostrato una riduzione dei punteggi sintomatici a 12 settimane
- Il quarto gruppo ha mostrato la maggiore percentuale di cambiamento nei punteggi istologici finora
- Nessun evento avverso grave riportato in tutti e quattro i gruppi completamente dosati
I dati del quarto gruppo hanno mostrato:
- Riduzione media del 45% dei punteggi sintomatici a 12 settimane
- Riduzione media del 39% nei punteggi di stadio composito istologico
- Riduzione media del 67% nel conteggio degli eosinofili di picco
Questi risultati sono comparabili con le terapie EoE attualmente approvate. La società rimane ottimista riguardo a ulteriori miglioramenti man mano che lo studio progredisce verso un dosaggio ottimale.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) anunció datos positivos de su ensayo RESOLVE de fase 1b/2a de EP-104GI para el tratamiento de la esofagitis eosinofílica (EoE). Los hallazgos clave incluyen:
- 10 de los 11 pacientes evaluables en los primeros cuatro grupos experimentaron una reducción en los puntajes de síntomas a las 12 semanas
- El cuarto grupo mostró el mayor cambio porcentual en los puntajes histológicos hasta la fecha
- No se reportaron eventos adversos graves en los cuatro grupos completamente dosificados
Los datos del cuarto grupo mostraron:
- Reducción media del 45% en los puntajes de síntomas a las 12 semanas
- Reducción media del 39% en los puntajes de etapa compuesta histológica
- Reducción media del 67% en el conteo de eosinófilos máximos
Estos resultados son comparables a las terapias EoE actualmente aprobadas. La compañía sigue siendo optimista sobre futuras mejoras a medida que avanza el ensayo hacia una dosificación óptima.
유프락시아 제약(Eupraxia Pharmaceuticals, TSX/NASDAQ: EPRX)은 EoE(호산구 식도염) 치료를 위한 EP-104GI의 RESOLVE 1b/2a 시험에서 긍정적인 데이터를 발표했습니다. 주요 발견은 다음과 같습니다:
- 처음 네 개의 그룹 중 11명의 평가 가능한 환자 중 10명이 12주 후 증상 점수가 감소했습니다
- 네 번째 그룹은 지금까지 가장 큰 비율 변화가 있는 조직학 점수를 보였습니다
- 모든 네 개의 충분히 용량을 투여한 그룹에서 심각한 부작용이 보고되지 않았습니다
네 번째 그룹의 데이터는 다음과 같았습니다:
- 12주 후 평균 45% 증상 점수 감소
- 평균 39% 조직학 복합 단계 점수 감소
- 평균 67% 최대 호산구 수 감소
이 결과는 현재 승인된 EoE 치료제와 비교할 수 있습니다. 회사는 시험이 최적 용량으로 진행됨에 따라 향후 개선에 대해 낙관적입니다.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) a annoncé des données positives de son essai RESOLVE de phase 1b/2a pour EP-104GI dans le traitement de l'œsophagite éosinophile (EoE). Les principaux résultats incluent:
- 10 des 11 patients évaluables des quatre premières cohortes ont présenté une réduction des scores de symptômes après 12 semaines
- La quatrième cohorte a montré le plus grand changement en pourcentage des scores histologiques à ce jour
- Aucun événement indésirable grave rapporté dans les quatre cohortes entièrement dosées
Les données de la quatrième cohorte ont montré:
- Réduction moyenne de 45% des scores de symptômes après 12 semaines
- Réduction moyenne de 39% des scores d'étape composite histologique
- Réduction moyenne de 67% du nombre maximal d'éosinophiles
Ces résultats sont comparables aux thérapies EoE actuellement approuvées. L'entreprise reste optimiste quant à de futures améliorations à mesure que l'essai progresse vers une posologie optimale.
Eupraxia Pharmaceuticals (TSX/NASDAQ: EPRX) hat positive Daten aus seiner RESOLVE-Studie der Phase 1b/2a zu EP-104GI zur Behandlung der eosinophilen Ösophagitis (EoE) veröffentlicht. Die wichtigsten Ergebnisse umfassen:
- 10 der 11 bewertbaren Patienten in den ersten vier Kohorten zeigten eine Reduktion der Symptomwerte nach 12 Wochen
- Die vierte Kohorte zeigte bisher die größte prozentuale Veränderung der Histologie-Werte
- Es wurden keine schwerwiegenden unerwünschten Ereignisse in allen vier vollständig dosierten Kohorten berichtet
Die Daten der vierten Kohorte zeigten:
- Durchschnittliche Reduktion von 45% der Symptomwerte nach 12 Wochen
- Durchschnittliche Reduktion von 39% der histologischen Kompositstufenwerte
- Durchschnittliche Reduktion von 67% bei den maximalen Eosinophilen-Zahlen
Diese Ergebnisse sind mit derzeit zugelassenen EoE-Therapien vergleichbar. Das Unternehmen bleibt optimistisch hinsichtlich weiterer Verbesserungen, während die Studie auf die optimale Dosierung hinarbeitet.
- 10 of 11 evaluable patients experienced reduced symptom scores at 12 weeks
- Fourth cohort showed 45% mean reduction in symptom scores at 12 weeks
- 39% mean reduction in histology composite stage scores in fourth cohort
- 67% mean reduction in peak eosinophil counts in fourth cohort
- Results comparable to currently approved EoE therapies
- No serious adverse events reported across all four cohorts
- None.
The clinical data from Eupraxia's RESOLVE Phase 1b/2a trial for EP-104GI in eosinophilic esophagitis (EoE) shows promising early results. Key findings include:
- Consistent symptom improvement, with 10 of 11 patients experiencing reduced SDI scores at 12 weeks
- The fourth cohort showed the greatest histological improvement to date, with mean reductions of
39% in EoEHSS Composite Stage and37% in Composite Grade - Mean
67% reduction in Peak Eosinophil Counts at 12 weeks in the fourth cohort
These results are comparable to currently approved therapies, suggesting EP-104GI's potential efficacy. The dose-response relationship and correlation between drug dose and histological response are particularly encouraging. However, it's important to note this is still an early-stage trial with a small sample size and further studies are needed to confirm these findings.
Eupraxia's DiffuSphere™ technology demonstrates innovative potential in drug delivery for EoE treatment. The localized administration of EP-104GI directly into the esophageal wall is a novel approach that may offer advantages over traditional surface-coating methods. This targeted delivery could potentially:
- Improve drug efficacy by reaching deeper esophageal tissues
- Enhance esophageal remodeling
- Reduce systemic side effects
The ongoing dose-escalation study will be important in determining the optimal dosing regimen. If successful, this technology could have broader applications beyond EoE, potentially revolutionizing treatments for other inflammatory conditions and even oncology. However, investors should remain cautious as the technology is still in early clinical stages and faces regulatory hurdles before commercialization.
This clinical update presents a positive outlook for Eupraxia Pharmaceuticals. Key financial implications include:
- Potential market opportunity: With over 450,000 EoE patients in the US alone, a successful treatment could capture significant market share
- Competitive positioning: EP-104GI's efficacy comparable to approved therapies suggests strong market potential
- Pipeline value: The DiffuSphere™ technology's versatility could lead to multiple revenue streams across various indications
However, investors should consider that Eupraxia is still in early clinical stages, with significant R&D expenses and no immediate revenue prospects from EP-104GI. The company's financial health and cash runway will be critical factors to monitor. While the news is encouraging, it's important to balance optimism with the inherent risks of biotechnology investments, including potential regulatory setbacks and competition from established players in the EoE market.
- Consistent improvement in patient reported outcomes with 10 of 11 evaluable patients in the first four cohorts experiencing a reduction in symptom (SDI1) scores at 12 weeks
- The fourth cohort showed the greatest percentage change in histology (EoEHSS2) scores of any cohort to date
- The RESOLVE Phase 1b/2a trial is progressing as anticipated with no serious adverse events reported in all four fully-dosed cohorts
New Clinical Data from the Fourth Cohort of the RESOLVE Trial
The results announced today from the fourth cohort of the RESOLVE trial, using Eupraxia's DiffuSphere™ technology for EoE, are derived from twelve 2.5 mg injections of EP-104GI (total dose of 30 mg) administered to less than two-thirds of each patient's lower esophagus. The data show:
- 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 four points (
67% from baseline). At 12 weeks post-administration, SDI was reduced by a mean of45% or 3.3 points – a level comparable with currently approved therapies. - 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, with a mean
39% reduction in Composite Stage and a mean37% reduction in Composite Grade at 12 weeks – a level comparable with currently approved therapies. - 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 was
67% at 12 weeks.
Notes
1. | 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. |
2. | 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. |
3. | 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. |
"The RESOLVE trial is progressing rapidly and we continue to observe positive data on efficacy and safety outcomes with EP-104GI, with the fifth cohort expected to read out in November 2024," said Dr. James Helliwell, Chief Executive Officer of Eupraxia. "Overall, we are encouraged by the data that we have seen across a number of key metrics and remain optimistic that we'll see further improvements in patient response as the trial progresses towards an optimal dosing level."
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 4 to 20 injections into the esophageal wall. Dose escalations increase the dose per site and/or number of sites. Participants in the first through the fourth cohorts will be assessed for up to 24 weeks. Patients in cohorts five and above will be assessed for 52 weeks.
Dr. Helliwell added, "In each of the trial's successive cohorts, patients are injected with EP-104GI at either higher doses or across a greater number of injection sites. We anticipate that the dose-escalating cohorts will allow us to evaluate the trial's emerging dose-response relationship. In addition, biopsies measuring tissue health have demonstrated a correlation between the dose of drug and the response on histology. This is exactly the outcome we hope to see in a dose-escalation trial such as this."
Dr. Evan S. Dellon, MD, MPH (University of North Carolina School of Medicine) and Chairman of the Company's Gastrointestinal Clinical Advisory Board, commented, "I'm encouraged to see the positive trends in the SDI1, EoEHSS2 and PEC3 scores as the trial continues. These metrics have emerged as key data points to help clinicians better understand a patient's esophageal health and will be important in informing the design of the Company's late-stage clinical trials. We believe that EP-104GI has the potential to contribute to improved overall esophageal health in patients, in part, because it is being injected into the deeper areas of the esophagus versus coating the surface of the tissues, which may help to improve esophageal remodeling."
The Company intends to continue to periodically disclose additional data from the trial.
New Clinical Data from the Third Cohort in the RESOLVE Trial
The results announced today from the third cohort of the RESOLVE trial, using Eupraxia's DiffuSphere™ technology for EoE, are derived from eight 2.5mg injections of EP-104GI (total dose of 20 mg) administered to a portion of each patient's lower esophagus. The data show:
- SDI1 was
50% lower in one of two evaluable patients at 24 weeks. A third patient in this cohort discontinued evaluation for reasons unrelated to the study. - EoEHSS2 Composite Stage and Composite Grade scores were both lower than baseline at 12 weeks post-administration, showing an average reduction of
7% and15% , 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
55% at 12 weeks.
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
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 expected benefits to patients with respect to safety, efficacy, duration and tolerability; 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 Company's product candidates, including expected benefits to patients; 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 our 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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FAQ
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