Summit Therapeutics Inc. (SMMT)
Summit Therapeutics Inc. is a biopharmaceutical firm dedicated to discovering, developing, and commercializing therapeutic solutions, primarily targeting infectious diseases across the United States and Latin America. The company's clinical development pipeline is heavily concentrated on therapies for Clostridioides difficile infection (CDI). Its flagship product candidate, ridinilazole, is an orally administered small molecule antibiotic currently advancing through Phase III clinical trials as a treatment for CDI. Beyond its lead asset, Summit Therapeutics is also progressing SMT-738, designed to combat multidrug-resistant infections, notably carbapenem-resistant Enterobacteriaceae (CRE). Additionally, its DDS-04 series represents a potential therapeutic avenue for various infections caused by the Enterobacteriaceae family of bacteria. Established in 2003, the company maintains its headquarters in Cambridge, Massachusetts.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Summit Therapeutics Inc.
- ivonescimabPDUFAEGFR-mutated, locally advanced or metastatic non-squamous non-small cell lung cancer after prior third-generation EGFR TKICash runway at this date: 14mo
- ivonescimabREADOUTCash runway at this date: 15mo
Trials need funding. See this company's dilution risk and cash position.
- Oct 24, 2026ivonescimabLunit SCOPE IO
- Oct 23, 2026ivonescimabLunit SCOPE IO
- Oct 21, 2026ivonescimab (SMT112)EA2251 (NCT07765433)
- Jan 1, 1970ivonescimabEA2251
- Phase 3Completed
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Ridinilazole, Vancomycin
Clostridioides Difficile Infection
NCT03595553Enrollment759StartJan 2019Primary CompletionNov 2021CompletionNov 2021 - Phase 3Terminated
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
Ridinilazole, Vancomycin
Clostridioides Difficile Infection
NCT04802837Enrollment2StartMay 2021Primary CompletionSep 2021CompletionSep 2022 - Phase 3Active, not recruiting
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Ivonescimab Injection, Pembrolizumab Injection
Non-Small Cell Lung Cancer
NCT05899608Enrollment1,600StartOct 2023Primary CompletionDec 2028est.CompletionDec 2029est. - Phase 3Active, not recruiting
Phase III Study of AK112 for NSCLC Patients
AK112 Injection, Placebo Injection
Non-Squamous Non-small Cell Lung Cancer
NCT06396065Enrollment420StartMay 2023Primary CompletionApr 2025CompletionDec 2026est. - Phase 3Recruiting
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
Ivonescimab Injection, Pembrolizumab Injection
Non-Small Cell Lung Cancer
NCT06767514Enrollment780StartFeb 2025Primary CompletionApr 2028est.CompletionJun 2029est. - Phase 3Recruiting
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
Drug: Ivonescimab Injection, Drug: Bevacizumab Injection
Metastatic Colorectal Cancer (CRC)
NCT07228832Enrollment600StartNov 2025Primary CompletionMay 2028est.CompletionNov 2029est. - Phase 2/3Recruiting
A Study of Ivonescimab in Combination With Enfortumab Vedotin vs Pembrolizumab in Combination With Enfortumab Vedotin in Metastatic Urothelial Carcinoma
Ivonescimab Dose 1, enfortumab vedotin (EV)
Metastatic Urothelial Carcinoma, Metastatic Urothelial Carcinoma (UC)
NCT07815665Enrollment800StartSep 2026est.Primary CompletionOct 2030est.CompletionDec 2030est. - Phase 2Completed
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
SMT19969, Vancomycin
Clostridium Difficile Infection
NCT02092935Enrollment100StartApr 2014Primary CompletionOct 2015CompletionOct 2015 - Phase 2Completed
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
Ridinilazole, Fidaxomicin
Clostridium Difficile Infection
NCT02784002Enrollment27StartDec 2014Primary CompletionAug 2016CompletionAug 2016 - Phase 2Terminated
Proof of Concept Study to Assess Activity and Safety of SMT C1100 (Ezutromid) in Boys With Duchenne Muscular Dystrophy (DMD)
Ezutromid
Duchenne Muscular Dystrophy
NCT02858362Enrollment43StartJun 2016Primary CompletionApr 2018CompletionSep 2018 - Phase 2Not yet recruiting
A Clinical Study of Ivonescimab in Combination With Cadonilimab or Ipilimumab for Advanced Renal Cancer
Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab
Renal Cell Carcinoma, Clear Cell
NCT07877194Enrollment100StartOct 2026est.Primary CompletionApr 2029est.CompletionDec 2029est. - Phase 1Completed
A Phase 1b Study of SMT C1100 in Subjects With Duchenne Muscular Dystrophy (DMD)
SMT C1100
Duchenne Muscular Dystrophy
NCT02056808Enrollment12StartNov 2013Primary CompletionMay 2014CompletionJul 2014 - Phase 1Completed
Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet
SMT C1100, SMT C1100
Muscular Dystrophy, Duchenne
NCT02383511Enrollment12StartFeb 2015Primary CompletionAug 2015CompletionAug 2015
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Ridinilazole, Vancomycin | NCT03595553 |
| Phase 3 | Terminated | Ridinilazole, Vancomycin | NCT04802837 |
| Phase 3 | Active, not recruiting | Ivonescimab Injection, Pembrolizumab Injection | NCT05899608 |
| Phase 3 | Active, not recruiting | AK112 Injection, Placebo Injection | NCT06396065 |
| Phase 3 | Recruiting | Ivonescimab Injection, Pembrolizumab Injection | NCT06767514 |
| Phase 3 | Recruiting | Drug: Ivonescimab Injection, Drug: Bevacizumab Injection | NCT07228832 |
| Phase 2/3 | Recruiting | Ivonescimab Dose 1, enfortumab vedotin (EV) | NCT07815665 |
| Phase 2 | Completed | SMT19969, Vancomycin | NCT02092935 |
| Phase 2 | Completed | Ridinilazole, Fidaxomicin | NCT02784002 |
| Phase 2 | Terminated | Ezutromid | NCT02858362 |
| Phase 2 | Not yet recruiting | Ivonescimab (dose level 1) combined with Cadonilimab, Ivonescimab (dose level 2) combined with Cadonilimab | NCT07877194 |
| Phase 1 | Completed | SMT C1100 | NCT02056808 |
| Phase 1 | Completed | SMT C1100, SMT C1100 | NCT02383511 |