Medicines in Development ꟷ Antimicrobial Resistance (AMR)
Product Name Sponsor Indication Development Phase
514G3 Xbiotech USA Staphylococcus aureus infections, Phase I/II completed (omodenbamab) Austin, TX including methicillin-resistant www.xbiotech.com Staphylococcus aureus (MRSA) (Fast Track)
AB103 (reltecimod) Atox Bio necrotizing soft tissue infections application submitted (synthetic peptide) Durham, NC (adjuvant) (Fast Track) www.atoxbio.com ORPHAN DRUG afabicin (Debio 1450) Debiopharm bone and joint infections due to Phase II (Fabl inhibitor) Lausanne, Switzerland Staphylococcus aureus , including www.debiopharm.com MRSA and methicillin-susceptible Staphylococcus aureus (MSSA) (Fast Track)
ALS-4 Aptorum Staphylococcus aureus infections, Phase I (bacterial virulence inhibitor) New York, NY including MRSA www.aptorumgroup.com
AP-PA02 Armata Pharmaceuticals multi-drug resistant Pseudomonas Phase I/II (bacteriophage cocktail) Marina del Rey, CA aeruginosa lung infections in cystic www.armatapharma.com fibrosis
AR-101 IgM mAb Aridis Pharmaceuticals hospital-acquired bacterial Phase II (lipopolysaccharide inhibitor) Los Gatos, CA pneumonia (HABP)/ventilator-acquired www.aridispharma.com ORPHAN DRUG bacterial pneumonia (VABP) caused by multi-drug resistant Pseudomonas aeruginosa LPS serotype 011
Medicines in Development: Antimicrobial Resistance ǀ 2021 1 Product Name Sponsor Indication Development Phase
AR-301 IgG1 mAb Aridis Pharmaceuticals HABP/VABP caused by Staphylococcus Phase III (bacterial toxin inhibitor) Los Gatos, CA aureus , including MRSA and MSSA www.aridispharma.com (Fast Track)
AR-501 Aridis Pharmaceuticals antibiotic-resistant gram-negative Phase I/II (bacterial growth inhibitor) Los Gatos, CA and gram-positive infections in www.aridispharma.com ORPHAN DRUG cystic fibrosis, including Pseudomonas aeruginosa (Fast Track)
ART24 Artugen Therapeutics prevention of recurrent Clostridioides Phase I (direct-acting live biotherapeutic) Concord, MA difficile infections (Fast Track) www.artugentherapeutics.com
ARV-1801 (fusidic acid) Arrevus Staphylococcus aureus respiratory Phase II (sodium fusidate-protein Raleigh, NC tract infections in cystic fibrosis www.arrevus.com synthesis inhibitor) ORPHAN DRUG aztreonam-avibactam (PF-06947387) Pfizer gram-negative bacterial infections Phase III (beta lactam/beta lactamase New York, NY with limited or no treatment options www.pfizer.com inhibitor)
BOS-228 Boston Pharmaceuticals multi-drug resistant bacterial Phase II (monobactam) Cambridge, MA infections (Fast Track) www.bostonpharmaceuticals.com brilacidin Innovation Pharmaceuticals acute bacterial skin and skin Phase II (defensin biomimetic) Wakefield, MA structure infections (ABSSSI) www.ipharminc.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 2 Product Name Sponsor Indication Development Phase cefepime/enmetazobactam Allecra Therapeutics complicated urinary tract infections Phase III (beta lactam/beta lactamase Lörrach, Germany (cUTI), including pyelonephritis www.allecra.com inhibitor) (Fast Track) cefepime/taniborbactam (IV) VenatoRx Pharmaceuticals cUTI, including pyelonephritis Phase III (beta lactam/beta lactamase Malvern, PA (Fast Track) www.venatorx.com inhibitor) ceftibuten/VNRX-7145 (oral) VenatoRx Pharmaceuticals multi-drug resistant bacterial Phase I (cell wall inhibitor/beta lactamase Malvern, PA infections (Fast Track) www.venatorx.com inhibitor)
CG400549 CrystalGenomics ABSSSI Phase II completed (enoyl-ACP reductase inhibitor) Seongnam-si, South Korea www.crystalgenomics.com colistimethate sodium inhaled Zambon non-cystic fibrosis bronchiectasis Phase III (cell membrane modulator) Bresso, Italy caused by Pseudomonas aeruginosa www.zambon.com
Contepo™ (ZTI-01) Nabriva Therapeutics cUTI (Fast Track) application submitted fosfomycin King of Prussia, PA www.nabriva.com (intravenous epoxide antibiotic)
cUTI (pediatric) Phase I www.nabriva.com contezolid (MRX-1) MicuRx Pharmaceuticals ABSSSI (Fast Track) Phase II (protein synthesis inhibitor) Foster City, CA www.micurx.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 3 Product Name Sponsor Indication Development Phase contezolid acefosamil (MRX-4) MicuRx Pharmaceuticals ABSSSI (Fast Track) Phase II (protein synthesis inhibitor) Foster City, CA www.micurx.com
CP101 Finch Therapeutics prevention of recurrent Clostridioides Phase II (microbiome therapeutic) Somerville, MA difficile infections www.finchtherapeutics.com (Breakthrough Therapy) (Fast Track)
CRS3123 Crestone Clostridioides difficile infections Phase II (MetRS inhibitor) Boulder, CO www.crestonepharma.com
CYT107 RevImmune NTM infections Phase II (recombinant interleukin-7) Bethesda, MD www.revimmune.com
Defencath® CorMedix prevention of catheter-related application submitted taurolidine, citrate, heparin Berkeley Heights, NJ bloodstream infections caused by www.cormedix.com (antibacterial/antifungal solution) gram-negative and gram-positive bacteria in patients on dialysis (Fast Track)
Deltyba® Otsuka Pharmaceutical multi-drug resistant Mycobacterium Phase III delamanid Princeton, NJ tuberculosis www.otsuka.com
DNV3837 Deinove Clostridioides difficile infections Phase II (hybrid oxazolidanone-quinolone) Grabels, France (Fast Track) www.deinove.com
D-PLEX-100 PolyPid prevention of surgical site infections Phase III (doxycycline polymer-lipid Summit, NJ (Breakthrough Therapy) (Fast Track) www.polypid.com encapsulated matrix)
Medicines in Development: Antimicrobial Resistance ǀ 2021 4 Product Name Sponsor Indication Development Phase
ETX0282CPDP Entasis Therapeutics cUTI Phase I (cefpodoxime/ETX 0282) Waltham, MA www.entasistx.com exebacase (CF-301) ContraFect bacteremia, including endocarditis Phase III (recombinant bacteriophage- Yonkers, NY caused by Staphylococcus aureus www.contrafect.com derived lysin) (Breakthrough Therapy) (Fast Track)
F901318 (olorofim) F2G Biotech invasive fungal infections refractory Phase II (antifungal) Manchester, United Kingdom or intolerant to current treatments www.f2g.com ORPHAN DRUG (Breakthrough Therapy) fosmanogepix Amplyx Pharmaceuticals invasive candidiasis/candidemia Phase II (Gwt1 fungal enzyme inhibitor) San Diego, CA (Fast Track), invasive aspergillosis, www.amplyx.com ORPHAN DRUG drug-resistant Candida auris gepotidacin (GSK2140944) GlaxoSmithKline gonorrhea, uncomplicated urinary Phase III (triazaacenaphthylene bacterial type Research Triangle Park, NC tract infections (uUTI) www.gsk.com II topoisomerase inhibitor)
GSK2556286 GlaxoSmithKline Mycobacterium tuberculosis Phase I (Mycobacterium tuberculosis Research Triangle Park, NC www.gsk.com cholesterol dependent inhibitor)
GSK3036656 GlaxoSmithKline Mycobacterium tuberculosis Phase II (Leucyl t-RNA synthetase inhibitor) Research Triangle Park, NC www.gsk.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 5 Product Name Sponsor Indication Development Phase
GSK3729098 (BVL-GSK098) BioVersys Mycobacterium tuberculosis Phase I (ethionamide booster) Basel, Switzerland www.gsk.com GlaxoSmithKline Research Triangle Park, NC
GSK3882347 GlaxoSmithKline uUTI Phase I (FimH antagonist) Research Triangle Park, NC www.gsk.com ibezapolstat (ACX-362E) Acurx Pharmaceuticals Clostridioides difficile infections Phase II (Pol IIIC inhibitor) White Plains, NY (Fast Track) www.acurxpharma.com ibrexafungerp SCYNEXIS acute vulvovaginal candidiasis application submitted (glucan synthase inhibitor) Jersey City, NJ (Fast Track) www.scynexis.com ORPHAN DRUG
recurrent vulvovaginal candidiasis, Phase III refractory or intolerant invasive www.scynexis.com fungal infections
invasive aspergillosis (Fast Track) Phase II www.scynexis.com
KBP-7072 KBP Biosciences multi-drug resistant bacterial Phase I (third generation tetracycline) Princeton, NJ infections (Fast Track) www.kbpbio.com
LBP-EC01 Locus Biosciences UTI Phase I (CRISPR-Cas3 bacteriophage) Research Triangle Park, NC www.locus-bio.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 6 Product Name Sponsor Indication Development Phase
LMN-101 Lumen Bioscience Traveler's diarrhea caused by Phase II (neutralizing antibody cocktail) Seattle, WA Campylobacter jejuni and Escherichia www.lumen.bio coli
MAT2203 Matinas BioPharma Nanotechnologies invasive fungal infections Phase II (encochleated amphotericin B) Bridgewater, NJ (mucocutaneous candidiasis) www.matinasbiopharma.com (Fast Track)
MAT2501 Matinas BioPharma Nanotechnologies NTM infections Phase I (oral encochleated amikacin) Bridgewater, NJ www.matinasbiopharma.com ORPHAN DRUG
ME1100 Meiji Seika Pharma HABP/VABP (Fast Track) Phase I completed (arbekacin inhalation) Tokyo, Japan www.meiji.com
MGB-BP-3 (oral) MGB Biopharma Clostridioides difficile infections Phase II (genetic transcription inhibitor) Bellshill, United Kingdom (Fast Track) www.mgb-biopharma.com
MRX-8 MicuRx Pharmaceuticals multi-drug resistant gram-negative Phase I (polymyxin derivative) Foster City, CA infections www.micurx.com nemonoxcin TaiGen Biotechnology community-acquired bacterial Phase II completed (bacterial DNA topoisomerase Taipei City, Taiwan pneumonia (CABP) (Fast Track), www.taigenbiotech.com inhibitor) diabetic foot infections
NTCD-M3 Destiny Pharma Clostridioides difficile infections Phase II completed (non-toxigenic strain of C. difficile, Brighton, United Kingdom (Fast Track) www.destinypharma.com bacteria replacement)
Medicines in Development: Antimicrobial Resistance ǀ 2021 7 Product Name Sponsor Indication Development Phase
Nu-3 Lakewood-Amedex complicated diabetic foot infections Phase I/II completed (bisphosphocin synthetic antibiotic) Sarasota, FL www.lakewoodamedex.com
OPC-167832 Otsuka Pharmaceutical Mycobacterium tuberculosis Phase I/II (DPrE1 inhibitor) Princeton, NJ www/otsuka.com
PhageBank™ Adaptive Phage Therapeutics multi-drug resistant prosthetic Phase I/II bacteriophage therapeutic Gaithersburg, MD joint infections, recurrent UTI www.aphage.com plasma gelsolin (pGSN) BioAegis Therapeutics severe CABP Phase I/II (protein replacement) North Brunswick, NJ www.bioaegistherapeutics.com
PLG0206 Peptilogics prosthetic joint infections Phase II (engineered cationic antibiotic Pittsburgh, PA www.peptilogics.com peptide) ORPHAN DRUG pravibismane (MBN-101) Microbion diabetic foot infections (Fast Track), Phase II (microbial bioenergetic inhibitor) Bozeman, MT orthopedic implant infections www.microbioncorp.com (Fast Track)
QPX7728 (OMNIvance™) Qpex Biopharma drug-resistant bacterial infections Phase I (beta-lactamase inhibitor) San Diego, CA (monotherapy & w/QPX2014) www.qpexbio.com
QPX7831 (ORAvance™) Qpex Biopharma gram-negative bacterial infections Phase I (beta-lactamase inhibitor) San Diego, CA www.qpexbio.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 8 Product Name Sponsor Indication Development Phase
RBX2660 (enema formulation) Rebiotix prevention of recurrent Clostridioides Phase III (microbiota restoration therapy) Roseville, MN difficile infections (Breakthrough www.rebiotix.com ORPHAN DRUG Therapy) (Fast Track)
RBX7455 (oral) Rebiotix prevention of recurrent Clostridioides Phase I (microbiota restoration therapy) Roseville, MN difficile infections www.rebiotix.com rezafungin Cidara Therapeutics fungal infections caused by Candida Phase III (long-acting echinocandin and San Diego, CA spp., including, candidemia and www.cidara.com glucan synthase inhibitor) invasive candidiasis (Fast Track), ORPHAN DRUG prevention of fungal infections caused caused by Aspergillosis and Pneumocystis in patients undergoing allogeneic blood and bone marrow transplantation
RG6006 Roche/Genentech Acinetobacter baumannii infections Phase I (antibiotic macrocyclic peptide) South San Francisco, CA www.roche.com
RHB-204 RedHill BioPharma NTM infections (Fast Track) Phase III (clarithromycin/clofazimine/rifabutin) Raleigh, NC www.redhillbio.com ORPHAN DRUG ribaxamase (SYN-004) Synthetic Biologics prevention of Clostridioides difficile Phase II (beta-lactamase enzyme) Rockville, MD infections co-administered with www.syntheticbiologics.com beta-lactam antibacterials ridinilazole Summit Therapeutics Clostridioides difficile infections Phase III (cell division inhibitor) Cambridge, MA (Breakthrough Therapy) (Fast Track) www.summittxinc.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 9 Product Name Sponsor Indication Development Phase
SER-109 Seres Therapeutics prevention of recurrent Clostridioides Phase III (microbiome therapeutic) Cambridge, MA difficile infections www.serestherapeutics.com ORPHAN DRUG (Breakthrough Therapy)
SPR206 Spero Therapeutics multi-drug resistant gram-negative Phase I (direct-acting antibiotic polymyxin) Cambridge, MA infections in the hospital www.sperotherapeutics.com
SPR720 Spero Therapeutics NTM infections Phase I completed (DNA replication inhibitor) Cambridge, MA www.sperotherapeutics.com ORPHAN DRUG sulbactam-durlobactam (IV) Entasis Therapeutics multi-drug resistant Acinetobacter Phase III (beta lactam-beta lactamase inhibitor) Waltham, MA baumannii infections (Fast Track) www.entasistx.com sulopenem (IV) Iterum Therapeutics cUTI (Fast Track), complicated intra- Phase III (synthetic penem) Chicago, IL abdominal infections (cIAI) (Fast Track) www.iterumtx.com sulopenem etzadroxil-probenecid Iterum Therapeutics uUTI (Fast Track) application submitted (oral prodrug of sulopenem) Chicago, IL www.iterumtx.com
cUTI (Fast Track), cIAI (Fast Track) Phase III www.iterumtx.com suvratoxumab (MEDI-4893) AstraZeneca prevention of nosocomial Phase II (mAb binding to S. aureus toxin) Wilmington, DE Staphylococcus aureus pneumonia www.astrazeneca.com (Fast Track)
Medicines in Development: Antimicrobial Resistance ǀ 2021 10 Product Name Sponsor Indication Development Phase tebipenem (SPR859) Spero Therapeutics gram-negative infections Phase I (oral carbapenem prodrug) Cambridge, MA www.sperotherapeutics.com tebipenem HBr (SPR994) Spero Therapeutics cUTI, including pyelonephritis Phase III (oral carbapenem prodrug) Cambridge, MA (Fast Track) www.sperotherapeutics.com telacebec (Q203) Qurient Therapeutics Mycobacterium tuberculosis Phase II completed (bacterial growth inhibitor) Seongnam-si, South Korea (Fast Track) www.qurient.com ORPHAN DRUG
TNP-2092 TenNor Therapeutics ABSSSI infections (Fast Track) Phase II (dual-acting antibacterial) Suzhou, China www.tennorx.com ORPHAN DRUG
prosthetic joint infections Phase I www.tennorx.com
TP-271 Tetraphase Pharmaceuticals respiratory bacterial infections Phase I completed (synthetic tetracycline antibiotic) Watertown, MA (Fast Track) www.tphase.com
TP-6076 Tetraphase Pharmaceuticals gram-negative bacterial infections Phase I completed (synthetic tetracycline antibiotic) Watertown, MA www.tphase.com
TRL1068 Trellis Bioscience prosthetic joint infections Phase I (broad-spectrum biofilm disruptor Redwood City, CA www.trellisbio.com human mAb)
TXA709 TAXIS Pharmaceuticals methicillin-resistant Staphylococcus Phase I (FtsZ inhibitor) Monmouth Junction, NJ aureus infections www.taxispharma.com
Medicines in Development: Antimicrobial Resistance ǀ 2021 11 Product Name Sponsor Indication Development Phase
VE303 Vedanta Biosciences high-risk recurrent Clostridioides Phase II (microbiome therapeutic) Cambridge, MA difficile infections (high-risk) www.vedantabio.com ORPHAN DRUG
VT-1161 Mycovia Pharmaceuticals recurrent vulvovaginal candidiasis Phase III (oteseconazole) Durham, NC (Fast Track) www.mycovia.com
VT-1598 Mycovia Pharmaceuticals coccidioidomycosis Phase I (tetrazole antifungal) Durham, NC (Fast Track) www.mycovia.com ORPHAN DRUG NQP 1598 Grand Cayman
WCK 4873 (nafithromycin) Wockhardt CABP Phase II completed (protein synthesis inhibitor) Maharashtra, India www.wockhardt.com
XF-73 (exeporfinium chloride) Destiny Pharma prevention of post-surgical Phase II (nasal cell membrane modulator) Brighton, United Kingdom Staphylococcus aureus infections www.destinypharma.com (Fast Track)
XNW4107 Sinovent bacterial infections Phase I (beta lactamase inhibitor) Suzhou, China (alone or with imipenem/cilastatin) www.sinovent.com.cn
YPT 01 Felix Biotechnology Pseudomonas aeruginosa infections Phase I/II (inhaled bacteriophage therapy) San Francisco, CA in cystic fibrosis www.felixbt.com
Zempia® Exoxemis prevention of surgical site Phase III completed myeloperoxidase-based Little Rock, AR infections www.exoxemis.com microbicidal (E-101)
Medicines in Development: Antimicrobial Resistance ǀ 2021 12 Product Name Sponsor Indication Development Phase
Zevtera® Basilea Pharmaceutica ABSSSI and bloodstream infections Phase III ceftobiprole Basel, Switzerland caused by Staphylococcus aureus www.basilea.com zoliflodacin (ETX0914) Entasis Therapeutics uncomplicated gonorrhea due to Phase III (DNA gyrase inhibitor) Waltham, MA N. gonorrhoeae (Fast Track) www.extasistx.com Global Antibiotic Research and Development Partnership Geneva, Switzerland
Approved Medicines in Testing for Additional Indications or Pediatric Population Product Name Sponsor Indication Development Phase
AriKayce® Insmed 1L nontuberous mycobacteria (NTM) Phase III amikacin liposome inhalation Bridgewater, NJ infections www.insmed.com
Cayston® Gilead Sciences Pseudomonas aeruginosa respiratory Phase III aztreonam for inhalation solution Foster City, CA tract infections in cystic fibrosis www.gilead.com (3 months to 18 years)
Cresemba® Astellas Pharma US invasive aspergillosis, invasive Phase II isavuconazonium (azole prodrug) Northbrook, IL mucormycosis (1 year to 17 years) www.astellas.com
Fetroja® Shionogi cUTI, HABP, VABP gram-negative Phase II cefiderocol Florham Park, NJ bacterial infections www.shionogi.com (3 months to 17 years )
Noxafil® Merck invasive aspergillosis (2 years to Phase II posaconazole Whitehouse Station, NJ 18 years), invasive fungal infections www.merck.com (up to 2 years)
Medicines in Development: Antimicrobial Resistance ǀ 2021 13 Product Name Sponsor Indication Development Phase
Nuzyra® Paratek Pharmaceuticals NTM infections Phase II omadacycline King of Prussia, PA www.paratekpharma.com
Recarbrio™ Merck gram-negative bacterial infections Phase II/III imipenem, cilastatin, relebactam Whitehouse Station, NJ (birth to 18 years) www.merck.com
Sivextro® Merck gram-positive bacterial infections Phase I tedizolid (IV and Oral) Whitehouse Station, NJ (up to 24 months) www.merck.com
Xenleta® Nabriva Therapeutics ABSSSI (Fast Track) Phase II completed lefamulin (IV/oral) King of Prussia, PA www.nabriva.com
CABP (pediatric) Phase I www.nabriva.com
Xerava® Tetraphase Pharmaceuticals bacterial infections Phase I eravacycline Watertown, MA (8 years to 17 years) www.tphase.com
Zerbaxa® Merck cUTI, including pyelonephritis Phase II ceftolozane and tazobactam Whitehouse Station, NJ (up to 17 years) www.merck.com
The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest information. Report current as of April 19, 2021. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials in the United States and abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in the United States. Some products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's website: www.phrma.org.
Medicines in Development: Antimicrobial Resistance ǀ 2021 14 Definitions
Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).
Breakthrough Therapy—Upon request by a sponsor, the FDA can grant this designation to expedite the development and review of a drug or biologic intended, alone or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically-significant endpoints, such as substantial treatment effects observed early in clinical development. If a drug or biologic is designated as a Breakthrough Therapy, the FDA will expedite the development and review. With this designation, all Fast Track features convey to the medicine.
Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational drug or biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.
Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition. In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or condition that affects usually fewer than 200,000 people in the United States.
Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.
Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an optimal dose, and to further evaluate its short-term safety.
Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients (but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies and usually take place in multiple sites around the world.
Medicines in Development: Antimicrobial Resistance ǀ 2021 15