EDP 235
Alternative Names: Direct acting antivirals - Enanta Pharamceuticals; EDP-235Latest Information Update: 11 May 2023
At a glance
- Originator Enanta Pharmaceuticals
- Class Antivirals; Small molecules
- Mechanism of Action Coronavirus-3C-like-proteinase inhibitors
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Phase II COVID 2019 infections
Most Recent Events
- 08 May 2023 EDP 235 is available for licensing as of 08 May 2023
- 08 May 2023 Efficacy, safety and pharmacokinetic data from a phase II SPRINT trial in COVID-19 infections released by Enanta pharmaceuticals
- 17 Apr 2023 Pharmacokinetics data from a preclinical study in COVID-2019 infections presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2023)
Development Overview
Introduction
EDP 235, a direct-acting (DAA) oral 3CL protease inhibiting small molecule antiviral candidate is being developed by Enanta Pharmaceuticals for the treatment and prevention of COVID-2019 infections. EDP 235 is designed to target conserved regions in the active site of a viral enzyme essential for SARS-CoV-2 replication. Therefore it prevents the viral replication, without being affected by the spike protein mutation. The candidate is being developed by taking a two-pronged approach to its COVID-19 discovery by testing compounds from Enanta's antiviral compound library for potential activity against COVID-19. Clinical development is underway in the US.
EDP 235 is available for licensing as of 08 May 2023 [1] .
Key Development Milestones
In March 2022, Enanta Pharmaceuticals announced that the US FDA has granted Fast Track designation for EDP 235 in the treatment of COVID-2019 infections. earlier in August 2021, company announced the intention to apply for a fast-track designation for EDP 235 in the treatment of COVID-2019 infections [2] [3] .
In May 2023, Enanta Pharmaceuticals announced that EDP 235 in a phase II SPRINT trial met its primary endpoint of demonstrating safety and tolerability, while secondary endpoints evaluating virologic effect were not met. Earlier, in November 2022, Enanta Pharmaceuticals initiated a phase II SPRINT trial of EDP 235 for the treatment of COVID-2019 infection (EDP235-101; NCT05616728). The randomized, double-blind, placebo-controlled trial intends to enroll approximately 200 non-hospitalized, symptomatic patients with mild to moderate COVID-19, who are not at increased risk for developing severe disease in the US (Enanta Pharmaceuticals pipeline, November 2022) [4] . In February 2023, Enanta Pharmaceuticals completed enrollment in its phase II SPRINT trial [5] .In May 2023, Enanta pharmaceuticals released efficacy, safety and pharmacokinetic data from a phase II SPRINT trial in COVID-19 [6] .
In November 2022, Enanta Pharmaceuticals completed a phase I drug-drug interaction trial that assessed the effects of EDP 235 on the pharmacokinetics and safety of midazolam, caffeine and rosuvastatin (NCT05594615; EDP 235-003). The non-randomized, open label study was initiated in October 2022, and enrolled 24 volunteers in the US [7] .
In December 2022, Enanta Pharmaceuticals competed the phase I trial which assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235 (NCT05594602; EDP 235-002). The open label, non randomised trial was initiated in October 2022 and enrolled 36 patients in the US [8]
In July 2022 Enanta Pharmaceuticals completed a phase I trial that evaluated the safety, tolerability, pharmacokinetics and the effect of food of oral EDP 235 for the treatment and prevention of COVID-19 infections (EDP 235-001; NCT05246878). The randomised, double blind, placebo controlled trial was initiated in January 2022 and enrolled 72 participants in the US. The study has single ascending doses (SAD), including a two-part food effect cohort, and multiple ascending doses (MAD) compared to placebo in healthy volunteers. All SAD and MAD cohorts will enroll eight participants who will be randomized to receive EDP-235 or placebo in a 3:1 ratio in USA. In February 2022, Enanta Pharmaceuticals dosed first patient in phase I trial. Earlier in May 2021, Enanta Pharmaceuticals announced that IND-enabling studies of EDP 235 is expected to initiate in Q2 of 2021 and plans to begin phase I trial in early 2022 [9] [3] [10] [11] . In July 2022, Enanta Pharmaceuticals released pharmacokinetics and safety data from phase I trial for the treatment of COVID-19 infections [12] . In March 2023, Enanta Pharmaceuticals reported that EDP 235, a potent, once-daily, oral antiviral, demonstrated excellent penetration into SARS-CoV-2 target tissues, with the potential for mitigation of viral rebound in Covid-19 patients [13] .
In April 2023, Enanta Pharmaceuticals presented preclinical pharmacokinetics data at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2023) [14] .
In January 2023, pharmacodynamics data from preclinical studies in COVID-2019 infections were released by Enanta Pharmaceuticals [15] . In October 2022, Enanta Pharmaceuticals presented pharmacokinetics data from preclinical studies in COVID-2019 infections at ID Week (IDW-2022) [16] [17]
In October 2021, Enanta Pharmaceuticals completed IND-enabling preclinical studies of EDP-235 and presented results at International Society for Influenza and Other Respiratory Virus Diseases (ISIRV)–World Health Organization (WHO) Virtual Conference 2021 (ISIRV-WHO 2021) [18] . In August 2021, Enanta Pharmaceuticals announced data from preclinical studies of EDP 235 in COVID-2019 infections models [3] . In May 2022, data from preclinical studies were released by Enanta Pharmaceuticals [19] .
As of March 2020, early research for the development of small molecule antiviral therapeutics is ongoing in the US [20] .
Drug Properties & Chemical Synopsis
- Route of administration PO
- Formulation Capsule
- Class Antivirals, Small molecules
- Target Coronavirus-3C-like-proteinase
- Mechanism of Action Coronavirus-3C-like-proteinase inhibitors
-
WHO ATC code
J05A (Direct acting antivirals)
-
EPhMRA code
J5 (Antivirals for Systemic Use)
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Phase II | USA (fast track) | PO / Capsule | Enanta Pharmaceuticals | 10 Nov 2022 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | COVID 2019 infections |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Enanta Pharmaceuticals | Originator | USA |
| Enanta Pharmaceuticals | Owner | USA |
Licensing Availability
| Licensing Organisation | Available Indication | Available Phase | Region | Date |
|---|---|---|---|---|
| Enanta Pharmaceuticals | - | Phase III | - | 08 May 2023 |
Scientific Summary
Pharmacokinetics
Phase II
Pharmacokinetics data from phase II SPRINT trial for EDP 235 in non-hospitalised, symptomatic patients with mild to moderate COVID-19 who were not at an increased risk for severe disease displayed pharmacokinetic profiles at the 200mg and 400mg doses consistent with previous studies, demonstrating 7x and 12x multiples over the protein-adjusted EC90 [6] [4] .
Phase I
In the phase I trial, EDP-235 exposure increased approximately proportionally with increasing single and multiple doses, with a consistent half-life ranging from 13 to 22 hours, resulting in a PK profile suitable for once-daily dosing. Exposure was enhanced with food administration of a standard meal. EDP-235 once-daily taken with food, resulted in mean trough plasma levels at steady state that were higher than the plasma protein adjusted EC90 of EDP-235 in Vero cells were as follows: for 200mg it was 3-fold for Alpha and 6-fold for Delta variant and for 400mg it was 6-fold for Alpha and 12-fold for Delta variant. Considering a preclinical lung to plasma ratio of 4:1, lung levels are predicted for 200mg it was 12-fold for Alpha and 24-fold for Delta variant and for 400mgit was 24-fold for Alpha and 48-fold for Delta variant suggesting strong exposures without the need for ritonavir [12] [11]
Updated results from a preclinical study that evaluated the intracellular uptake of EDP 235 compared to nirmatrelvir in both rat and human cells, showed that the ratios of intracellular to extracellular concentrations of EDP 235 in salivary gland epithelial cells, adipocytes, and macrophages were 11.3, 33.6 and 30.5, respectively, compared to ratios ranged from 0.6 to 1.2 for nirmatrelvir in these human cells. Consistent with the in vitro observations, EDP 235 showed excellent target tissue exposure with tissue-to-plasma ratios of 6.5 in salivary glands, 23.0 in adipose tissues, and 28.4 in lung alveolar macrophages, whereas nirmatrelvir had corresponding values of 0.8, 0.6, and 0.5. These preclinical data demonstrate that EDP 235 achieved preferential target tissue distribution and cell penetration, enabling EDP 235 to target viral reservoirs and minimize viral persistence [14] . Updated result from in vivo studies of rat lung alveolar macrophages (AM), human monocytes and human macrophages showed that the ratios of intracellular to extracellular concentrations of EDP 235 in rat lung AM, human monocytes and human macrophages were 23.6, 22.7 and 30.5, respectively, compared to ratios of 0.6, 1.5 and 1.2 for nirmatrelvir in these cells. Consistent with the in vitro observations, EDP 235 showed favorable rat AM penetration with an AUC(0-24) ratio of 28.4 (AM over plasma), and nirmatrelvir had less rat AM penetration with an AUC(0-24) ratio of 0.5 (AM over plasma). EDP 235 had respective AUC(0-24) values of 9.6 and 271.9 h µg/mL in rat plasma and AM, while the AUC(0-24) values of nirmatrelvir in rat plasma and AM were 2.7 and 1.2 h µg/mL, respectively. These preclinical data demonstrate that EDP 235 achieved excellent penetration into monocytes and macrophages, including lung AM. EDP 235 has the potential to eliminate viral replication of SARS-CoV-2 in these critical immune cells, thus mitigating macrophage-mediated cytokine storm in high-risk COVID-19 patients [16] . In preclinical studies, EDP 235 showed good human Caco-2 cell permeability and a low plasma clearance in human liver microsomes. Consistent with this in vitro data, EDP 235 had robust plasma exposure with an oral bioavailability of 95% in rats. Moreover, EDP 235 had favorable in vivo penetration into multiple target tissues, including lung, kidney, liver, and heart. These results indicated that, EDP 235 had good oral bioavailability and target tissue distribution compared to other antivirals in development for SARS-CoV-2 [18] .
Adverse Events
Phase II
Safety data from phase II SPRINT trial for EDP 235 in non-hospitalised, symptomatic patients with mild to moderate COVID-19 who were not at an increased risk for severe disease showed a low frequency of treatment emergent adverse events (TEAEs) was observed (1.3% and 6.4% in the EDP 235 200mg and 400mg arms, respectively, vs. 2.6% in placebo). Most TEAEs were mild in severity, with no serious TEAEs or discontinuations due to TEAEs. Laboratory values were generally unremarkable, although one patient receiving EDP 235 400mg who also used concomitant alcohol and acetaminophen experienced transient asymptomatic elevation of ALT (grade 4), AST (grade 3) and GGT with normal bilirubin and alkaline phosphatase. Transient elevations in total cholesterol and triglycerides were seen with EDP 235 treatment, trending toward baseline after completion of treatment [6] [4] .
Phase I
In the phase I trial, treatment with EDP 235 for COVID-19 was generally safe and well-tolerated in healthy volunteers up to 400 mg for up to seven days. The majority of adverse events (AEs) were mild, with headache and gastrointestinal related symptoms (e.g. nausea, abdominal discomfort) being the most frequently reported adverse events during the MAD phase. There were three study discontinuations: one moderate headache in the 400 mg fasted cohort, one severe headache in the 800 mg fed cohort and one grade 3 ALT/grade 2 AST elevation in the 800mg fed cohort [12] [11] .
Pharmacodynamics
Summary
Results from a preclinical in vivo study of EDP 235 highlight the robust antiviral treatment effect and prevention of COVID-19 transmission in a ferret model. In a study, ferrets were infected with SARS-CoV-2 and then subsequently received either EDP 235 or a vehicle. Results demonstrated that EDP 235 treatment of SARS-CoV-2-infected animals resulted in a rapid, robust, and sustained decline in viral replication. To understand the effect of EDP 235 on transmission, cohorts of infected animals who had been treated with EDP 235 were co-housed with healthy and untreated animals and monitored for infection. Results showed that healthy animals did not contract COVID-19 when co-housed with infected animals that were treated with EDP 235, whereas healthy animals co-housed with vehicle-treated infected animals did contract the virus [15] .
Preclinical results demonstrated that, EDP 235 potently and selectively inhibited SARS-CoV-2 replication in multiple cellular models, including primary human airway epithelial cells, with an EC90 of 33 nM. In a biochemical assay, EDP 235 inhibited the SARS-CoV-2 3CLpro protease with an IC50 of 5.8 nM. This activity was retained against proteases from SARS-CoV-2 variants. EDP 235 was shown to have potent antiviral activity across other human coronaviruses. In comparison to preclinical data from other direct acting antivirals in development for COVID-2019 infection, EDP 235 appeared to be among the most potent against SARS-CoV-2 in cellular assays. Additionally, EDP 235 had a clean preclinical safety profile and demonstrated a high barrier to resistance. Based on allometric scaling, EDP 235 was projected to have a long half-life of 16 hours with an efficacious dose of 100 to 500 mg once-daily in humans. Taken together, these data indicated that, EDP 35 has the potential for once-daily oral dosing with a low pill burden. In preclinical studies, EDP 235 had a clean preclinical safety profile and demonstrated a high barrier to resistance [18] [3] . Preclinical data demonstrated that EDP-235 is a potent inhibitor of SARS-CoV-2 3CLpro and shows potent antiviral activity against SARS-CoV-2 variants of concern, including Delta and Omicron. EDP-235 also showed potent antiviral activity against most other pathogenic human coronaviruses, potentially making it a pan-coronavirus therapy [19] .
Therapeutic Trials
Phase II
Efficacy data from phase II SPRINT trial for EDP 235231 in patients were randomized 1:1:1 to receive 200mg or 400mg EDP-235 in non-hospitalized, symptomatic patients with mild to moderate COVID-19 who were not at an increased risk for severe disease showed a dose-dependent improvement in symptoms was observed with EDP 235 treatment compared to placebo, which achieved statistical significance (p<0.05) in the 400mg treatment group at multiple time points, starting as early as one day after the first dose. In a prespecified population consisting of patients enrolled within 3 days of symptom onset, a statistically significant improvement was observed with EDP 235 at 400mg at all time points. An analysis of a subset of these symptoms showed a 2-day shorter time to improvement in patients receiving EDP 235 400mg who were enrolled within 3 days of symptom onset (p<0.01) showed no difference in time to improvement of 14 targeted COVID-19 symptoms. No effect on virologic endpoints as measured in the nose was detected due to the rapid viral decline in the placebo arm of this highly immunologically-experienced, standard risk population. A dose-dependent improvement in the key secondary endpoint of total symptom score (TSS) was demonstrated in patients treated with EDP 235 compared to placebo, despite the lack of virologic effect as measured in the nose. This improvement achieved statistical significance (p<0.05) in the 400mg treatment group at multiple time points, starting as early as one day after initiation of EDP 235 treatment. In the prespecified patient population enrolled within 3 days of symptom onset, a statistically significant improvement in TSS was observed with EDP 235 400mg compared to placebo at all measured time points (Days 1 -32 post dosing). While no difference was observed in time to improvement of 14 targeted COVID-19 symptoms, an analysis of a subset of 6 of these symptoms showed a 2-day shorter time to improvement in patients receiving EDP 235 400mg who were enrolled within 3 days of symptom onset (p<0.01 versus placebo). Also, Key secondary endpoints evaluating virologic effect were not met. No difference was observed between patients treated with EDP 235 and placebo in viral RNA decline or infectious viral load, likely due to the rapid viral decline in the placebo arm of this trial’s seropositive, standard risk population. The mean baseline viral load in this study population was approximately 5 log, and a precipitous decrease in viral RNA was observed in all study arms, indicating this highly immune population rapidly cleared virus from the nose. An additional analysis of patients with a baseline viral load greater than 5 log showed a decline of 0.4 log at Day 3 in both EDP 235 treatment arms compared to placebo.The findings from this trial also highlight the challenge of demonstrating a virologic effect in an otherwise healthy,highly immune-experienced adult population who are not at risk for severe disease [6] [4] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2023 | Trial Update | Enanta Pharmaceuticals plans a phase III trial for COVID-2019 infections in second half of 2023 (PO) [5] | 13 Feb 2023 |
| 31 Dec 2022 | Trial Update | Enanta Pharmaceuticals plans a phase II trial for COVID-2019 infections (Prevention) in December 2022 (PO). [10] | 18 Feb 2022 |
| 28 Feb 2022 | Trial Update | Enanta Pharmaceuticals plans a phase I trial for COVID-2019 infections in February 2022 [10] | 18 Feb 2022 |
| 30 Jun 2021 | Trial Update | Enanta Pharmaceuticals plans IND-enabling studies for COVID-2019 infections in Q2 2021 [21] | 11 Aug 2021 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 08 May 2023 | Licensing Status | EDP 235 is available for licensing as of 08 May 2023 [1] Updated 11 May 2023 |
| 08 May 2023 | Scientific Update | Efficacy, safety and pharmacokinetic data from a phase II SPRINT trial in COVID-19 infections released by Enanta pharmaceuticals [6] Updated 10 May 2023 |
| 17 Apr 2023 | Scientific Update | Pharmacokinetics data from a preclinical study in COVID-2019 infections presented at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID-2023) [14] Updated 24 Apr 2023 |
| 07 Feb 2023 | Trial Update | Enanta Pharmaceuticals completes enrolment in the Phase-II SPRINT trials in COVID-2019 infections, in USA (PO) [5] (NCT05616728) Updated 13 Feb 2023 |
| 07 Feb 2023 | Trial Update | Enanta Pharmaceuticals plans a phase III trial for COVID-2019 infections in second half of 2023 (PO) [5] Updated 13 Feb 2023 |
| 06 Jan 2023 | Scientific Update | Pharmacodynamics data from a preclinical studies in COVID-2019 infections released by Enanta Pharmaceuticals [15] Updated 10 Jan 2023 |
| 30 Dec 2022 | Trial Update | Enanta Pharmaceuticals completes the phase I trial in COVID-19 (In Volunteers) in USA (NCT05594602) Updated 08 May 2023 |
| 18 Nov 2022 | Trial Update | Enanta Pharmaceuticals completes a phase I trial in COVID-2019 infections (In volunteers) in USA (PO) (NCT05594615) Updated 11 May 2023 |
| 11 Nov 2022 | Phase Change - II | Phase-II clinical SPRINT trials in COVID-2019 infections, in USA (PO), before November 2022 (Enanta Pharmaceuticals pipeline, November 2022) (NCT05616728) Updated 11 Nov 2022 |
| 28 Oct 2022 | Trial Update | Enanta Pharmaceuticals initiates a phase I trial in COVID-2019 infections (In volunteers) in USA (NCT05594602) Updated 28 Oct 2022 |
| 19 Oct 2022 | Scientific Update | Pharmacokinetics data from a preclinical trial in COVID-2019 infections presented at ID Week (IDW-2022) [16] [17] Updated 23 Oct 2022 |
| 06 Oct 2022 | Trial Update | Enanta Pharmaceuticals initiates a phase I trial in COVID-2019 infections (In volunteers) in USA (NCT05594615) Updated 28 Oct 2022 |
| 02 Aug 2022 | Scientific Update | Pharmacokinetics and safety data from phase I trial for the treatment of COVID-19 infections was released by Enanta pharmaceuticals [12] Updated 02 Aug 2022 |
| 20 Jul 2022 | Trial Update | Enanta Pharmaceuticals completes a phase I trial in COVID-2019 infections (In volunteers) in USA (PO) (NCT05246878) Updated 02 Sep 2022 |
| 09 May 2022 | Scientific Update | Pharmacodynamics data from preclinical trials in COVID-2019 infections released by Enanta Pharmaceuticals [19] Updated 12 May 2022 |
| 30 Mar 2022 | Regulatory Status | EDP 235 receives Fast Track designation for COVID-2019 infections [PO] (In volunteers) in USA [2] Updated 31 Mar 2022 |
| 30 Mar 2022 | Regulatory Status | Enanta Pharmaceuticals intends to work with the FDA for further development of EDP 235 [2] Updated 31 Mar 2022 |
| 16 Feb 2022 | Trial Update | Enanta Pharmaceuticals plans a phase I trial for COVID-2019 infections in February 2022 [10] Updated 18 Feb 2022 |
| 16 Feb 2022 | Trial Update | Enanta Pharmaceuticals plans a phase II trial for COVID-2019 infections (Prevention) in December 2022 (PO). [10] Updated 18 Feb 2022 |
| 28 Jan 2022 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in USA (PO) (NCT05246878) Updated 25 Feb 2022 |
| 28 Jan 2022 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention) in USA (PO) [10] Updated 18 Feb 2022 |
| 21 Oct 2021 | Scientific Update | Pharmacodynamics and pharmacokinetics data from preclinical trials in COVID-2019 infections presented at International Society for Influenza and Other Respiratory Virus Diseases-World Health Organization (ISIRV–WHO 2021) Virtual Conference 2021 [18] Updated 21 Oct 2021 |
| 05 Aug 2021 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA, prior to August 2021 (PO) [3] Updated 11 Aug 2021 |
| 05 Aug 2021 | Regulatory Status | Enanta Pharmaceuticals plans to apply for Fast Track designation of EDP 235 in the treatment of COVID-2019 infections [3] Updated 11 Aug 2021 |
| 05 Aug 2021 | Scientific Update | Pharmacodynamics data from a preclinical trial in COVID-2019 infections released by Enanta Pharmaceuticals [3] Updated 11 Aug 2021 |
| 08 Feb 2021 | Trial Update | Enanta Pharmaceuticals plans IND-enabling studies for COVID-2019 infections in Q2 2021 [21] Updated 11 Aug 2021 |
| 13 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (unspecified route) before March 2020 [20] Updated 20 Mar 2020 |
References
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Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter with Conference Call and Webcast Today at 4:30 p.m. ET.
Media Release -
Enanta Pharmaceuticals Receives FDA Fast Track Designation for EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19.
Media Release -
Enanta Pharmaceuticals Announces Nomination of Clinical Candidate EDP-235, its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19.
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19
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Enanta Pharmaceuticals Reports Financial Results for its Fiscal First Quarter Ended December 31, 2022 with Webcast and Conference Call Today at 4:30 p.m. ET.
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Enanta Pharmaceuticals Reports Positive Topline Results from Phase 2 SPRINT Trial Evaluating EDP-235 in Standard Risk Patients with COVID-19.
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A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS
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A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS
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Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2021 with Webcast and Conference Call Today at 4:30 p.m. ET.
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Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Specifically Designed for the Treatment and Prevention of COVID-19.
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A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First In Human Study of Orally Administered EDP-235 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-235 Pharmacokinetics in Healthy Participants
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Enanta Pharmaceuticals Announces Positive Data from a Phase 1 Clinical Study of EDP-235, its Oral 3CL Protease Inhibitor Designed for the Treatment of COVID-19.
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Enanta Pharmaceuticals to Present New Data for EDP-235, its 3CL Protease Inhibitor, in Development as an Oral, Once-Daily Treatment for COVID-19, at the 36th International Conference on Antiviral Research.
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Enanta Pharmaceuticals Presents Data for its COVID-19 and Respiratory Syncytial Virus Programs at the 33rd European Congress of Clinical Microbiology and Infectious Diseases.
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Enanta Pharmaceuticals to Provide Updates on its Research and Development Programs and 2023 Outlook at the 41st Annual J.P. Morgan Healthcare Conference.
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Enanta Pharmaceuticals Presents New Preclinical Data for EDP-235, its Oral, Direct-Acting Antiviral Protease Inhibitor Specifically Designed for the Treatment of COVID-19 at IDWeek(T) 2022.
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Li Y, Zang TI, Xu L, Leonard D, Hoang K, Greizer T, et al. EDP-235, A Potent and Once-daily Oral Antiviral, Demonstrates Excellent Penetration into Macrophages and Monocytes, with the Potential for Mitigation of Cytokine Storm in High-Risk COVID-19 Patients. IDW-2022 2022; abstr. 1123.
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Enanta Pharmaceuticals Presents New Data for EDP-235, its Lead Oral Protease Inhibitor Designed for the Treatment of COVID-19, at the ISIRVWHO Virtual Conference 2021.
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