| Molecule | Partner | Indication | China Ph3 / Pivotal | Clinical Status | |||
|---|---|---|---|---|---|---|---|
| Planning | Enrollment | Global | APAC | ||||
| Therapeutics | Eravacycline (Xerava™) | cIAI | NDA approved in US, EU, UK | NDA approved in Singapore; NDA filed in China and Hong Kong | |||
| CABP | Phase 3 | - | |||||
| Nefecon | lgA nephropathy | NDA approved in US | NDA approved in US; Seek BLA approval based on US approval | ||||
| Etrasimod | Ulcerative colitis | Phase 3 | South Korea and Taiwan included in multi-regional trial | ||||
| Other autoimmune diseases (CD, AD) | Phase 2/3(1) | ||||||
| Ralinepag | PAH | Phase 3 | |||||
| Taniborbactam (VNRX-5133) | cUTI | Phase 3 | |||||
| FGF401 | HCC | Phase 1/2 | |||||
| XNW1011 | Renal disease | Phase 2 | |||||
| SPR206 | Gram negative infections | Phase 1 | |||||
| EDDC-2214 | COVID-19 oral antiviral treatments | Phase 1 | - | ||||
| mRNA Vaccines | PTX-COVID19-B | COVID-19 | Phase 2/3 | ||||
| EVER-COVID19-M1 | 2nd generation COVID-19 booster | Pre-clinical | - | ||||
| Pre-clinical Candidate 1 | Infectious disease | Pre-clinical | - | ||||
| Pre-clinical Candidate 2 | Infectious disease | Pre-clinical | - | ||||
| Pre-clinical Candidate 3 | Infectious disease | Pre-clinical | - | ||||
Eravacycline is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as a first-line empiric monotherapy for the treatment of MDR infections, including MDR Gram-negative infections. It was approved in 2018 in the United States and the EU for the treatment of complicated intra-abdominal infections (cIAI) and is marketed by our partner Tetraphase Pharmaceuticals under the trade name Xerava. As a broad-spectrum antibiotic, eravacycline covers the majority of the key resistant pathogens in China. In vitro studies have demonstrated its potency in clinical isolates commonly found in China, not only in extended-spectrum beta-lactamase producing strains, or ESBLs, but also in clinically challenging pathogens such as carbapenem-resistant Enterobacteriaceae (CRE) and Carbapenem resistant Acinetobacter baumannii (CRAB).
Greater China, South Korea, SE Asia
TARPEYO (budesonide developed under the project name NEFECON) is the first FDA-approved and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
TARPEYO (developed under the project name NEFECON) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. It was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy.
Greater China, Singapore, South Korea
Etrasimod is an oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. It is being investigated for a range of immuno-inflammatory diseases, including ulcerative colitis, Crohn’s disease, atopic dermatitis, eosinophilic esophagitis, and alopecia areata.
ELEVATE UC 52 and ELEVATE UC 12 trials that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod for the treatment of moderately-to-severely active ulcerative colitis achieved all primary and key secondary endpoints with a safety profile consistent with previous studies, demonstrating etrasimod’s best-in-class potential in ulcerative colitis. Everest Medicines is conducting a phase 3 study for etrasimod in Asia for the treatment of moderately-to-severely active ulcerative colitis.
Greater China, South Korea
Ralinepag is a next-generation, potent, selective oral IP prostacyclin receptor agonist being developed for the treatment of pulmonary arterial hypertension (PAH). This class of medicines has been shown to reduce mortality in PAH patients. In Phase 2 clinical trials, ralinepag demonstrated clinically meaningful and statistically significant efficacy in improving PAH patients’ clinical symptoms compared to placebo. An extended release formulation currently in global Phase 3 development, ralinepag XR, was designed to deliver intravenous prostacyclin-like potency and pharmacokinetics in an oral tablet.
Greater China, South Korea
Taniborbactam (formerly VNRX-5133) is a novel injectable beta-lactamase inhibitor (BLI) that features selective and potent in vitro and in vivo activity against both serine-beta-lactamases (SBLs) and metallo-beta-lactamases (MBLs). In a fixed dose combination with cefepime (a 4th generation cephalosporin), taniborbactam is expected to address unmet medical need for a safe and effective therapy for treatment of diseases due to MDR gram-negative bacteria, particularly extended spectrum beta-lactamase (ESBL) producing organisms, CRE and carbapenem resistant Pseudomonas aeruginosa.
Greater China, South Korea, SE Asia
FGF401 is a potential first-in-class, ATP-competitive, reversible-covalent inhibitor of FGFR4 for which we obtained global commercial rights from Novartis. We are developing FGF401 for hepatocellular carcinoma (HCC), which represents 90% of all liver cancers and is highly prevalent in China, causing over 300,000 deaths per year. FGF401 has undergone a dose escalation study and a phase 1b study in cancer patients that demonstrated single agent responses in HCC patients.
Worldwide
XNW1011 is a next-generation covalent reversible BTK inhibitor that exhibits high selectivity, excellent pharmacokinetics property, robust target engagement and a safety profile that supports continued development based in part on results from a completed phase 1 study with healthy subjects conducted by SinoMab in China.
Global rights for renal disease
SPR206 is a potentially best-in-class, novel polymyxin derivative that was designed to reduce the kidney toxicity that is seen clinically with polymyxin B and colistin. Polymyxins are antibiotics frequently used as a last resort for challenging MDR gram-negative infections, but they are associated with significant neurotoxicity and nephrotoxicity. In a double-blind, placebo-controlled Phase 1 clinical trial in healthy volunteers conducted by our partner Spero Therapeutics, SPR206 appeared well tolerated at doses likely to be within a therapeutic range for MDR Gram-negative bacterial infections. Importantly, it also showed no evidence of nephrotoxicity at the doses tested.
Greater China, South Korea, SE Asia
EDDC-2214 is a novel and potent SARS-CoV-2 3CL protease inhibitor, which Everest will develop as an oral antiviral COVID-19 therapy. The main protease in SARS-CoV-2 is the 3CL protease. Compared to several other oral COVID-19 antivirals, EDDC-2214 exhibits better in-vitro potency and pre-clinical oral bioavailability. Clinical trials evaluating EDDC-2214 are expected to begin in 2023.
Worldwide
PTX-COVID19-B is an mRNA vaccine in Phase 2 development for the treatment of COVID-19, which is designed to encode the S protein of SARS-CoV-2 encapsulated in a lipid nanoparticle (LNP). Interim data from Providence’s Phase 1 study showed that PTX-COVID19-B demonstrated strong virus neutralization capability and produced a level of antibodies in participants in the treatment arm that compare favorably to those produced by other mRNA vaccines that have been approved for use against COVID-19. The treatment was generally safe and well tolerated.
Greater China, Southeast Asia and Pakistan
