Company Product Description Indication Status
Phase I
Locus Biosciences Inc., of Morrisville, N.C. LBP-EC01 CRISPR-Cas3-enhanced bacteriophage targeting Escherichia coli Urinary tract infections Study met all of its primary and secondary endpoints
Longeveron Inc., of Miami Lomecel-B Allogeneic, bone marrow-derived medicinal signaling cell product Hypoplastic left heart syndrome Treatment was well-tolerated, with no major cardiac events, and no serious adverse events related to the therapy; full results expected in the 2Q2021; plans to start a phase II study in the 3Q2021
Marinomed Biotech AG, of Vienna Carragelose Iota-/kappa-carrageenan lozenges  Rhinovirus infection prophylaxis Carragelose concentration in subjects' saliva was 668 μg/ml, substantially above the 5 μg/ml required to neutralize 90% (IC90) of HRV1a and HRV8 rhinoviruses; concentration of carragelose in the saliva surpassed the IC90 for SARS-CoV-2; the saliva from subjects had antiviral efficacy against HRV-1a and HRV-8, Coronavirus OC43, Influenza A nH1N1 2009 and Coxsackie virus A10
Nanoform Finland plc, of Helsinki Piroxicam  Nanoformed oral immediate release tablet Arthritis In healthy subjects, 20 mg of nanoformed piroxicam had equal absorption performance compared to 20 mg of Brexidol (piroxicam, Chiesi Farmaceutici S.p.A.); standard deviation of absorption of the nanoformed formulation was lower than that of Brexidol or Felden (piroxicam, Pfizer Inc.)
Salarius Pharmaceuticals Inc., Houston Seclidemstat  Lysine-specific histone demethylase 1 inhibitor Relapsed and refractory Ewing sarcoma and Ewing-related sarcomas Started the expansion stage of the phase I/II study that includes up to 20 Ewing sarcoma patients treated with seclidemstat plus topotecan and cyclophosphamide and a second arm of up to 30 patients with Ewing-related sarcomas treated with seclidemstat; data expected towards the end of 2021 and into 2022
Takeda Pharmaceutical Co. Ltd., of Tokyo, and Novavax Inc., of Gaithersburg, Md. TAK-019/NVX-CoV2373  Recombinant protein-based vaccine COVID-19 prophylaxis First of up to 200 subjects treated in the phase I/II immunogenicity and safety study; data expected in the 2H2021
Phase II
Akero Therapeutics Inc., of South San Francisco Efruxifermin FGF21 mimic Nonalcoholic steatohepatitis Screened first patient for the phase IIb Harmony study comparing 2 dose levels of efruxifermin to placebo; primary endpoint for the trial is fibrosis regression at 24 weeks; top-line data expected in the 2H2022
Constant Therapeutics LLC, of Boston TXA-127   Angiotensin II receptor modulator COVID-19 Started study at the Rambam Medical Health Care Campus and Ziv Medical Center; study expected to be completed within 4 months
Neurorx Inc., of Radnor Zyesami (Aviptadil, RLF-100) Adrenergic receptor antagonist; VIP receptor agonist Respiratory failure in critically ill patients with COVID-19 In the phase IIb/III study, Zyesami produced a 35% higher likelihood of recovery from respiratory failure with continued survival compared to placebo (p=0.08); patients treated with drug were 46% more likely to recover and return home before day 28 (p=0.058); at day 28, median time to recovery and hospital discharge was 10 days better for Zyesami compared to placebo (p<0.006)
Theralase Technologies Inc., of Toronto TLD-1433 Light-activated photo dynamic compound Non-muscle invasive bladder cancer unresponsive or intolerant to Bacillus Calmette Guerin University of Wisconsin Health-Madison received site institutional review board approval to join the ongoing phase II study that has enrolled 15 patients to date; goal is to enroll 25 total patients in early 2021 and approximately 75-100 additional patients in 2021/2022
Theravance Biopharma Inc., of Dublin TD-0903 JAK inhibitor Hospitalized patients with COVID-19 who require oxygen All-cause mortality by day 28 was 17% for the 1-mg dose, 0% for 3-mg and 10-mg doses and 33% for placebo (6 patients in each group); clinical status worsening during the 7-day treatment was 0% for all doses compared to 50% for placebo; mean days to hospital discharge was 18.8, 15.3, 15.2 and 22.5 for the 1-mg, 3-mg, 10-mg doses and placebo, respectively
Phase III
Opthea Ltd., of Melbourne, Australia OPT-302 Soluble form of vascular endothelial growth factor receptor 3 Neovascular (wet) age-related macular degeneration Finalized protocols for the Shore and Coast studies; 990-patient Shore study will compare OPT-302 and Lucentis (ranibizumab, Roche Holding AG) every 4 weeks to OPT-302 every 8 weeks (after loading doses) and Lucentis every 4 weeks to the control group of Lucentis every 4 weeks; 990-patient Coast study will compare OPT-302 every 4 weeks plus Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) every 8 weeks (after loading doses) to OPT-302 and Eylea every 8 weeks (after loading doses) to the control of Eylea every 8 weeks (after loading doses); primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52
Otsuka Pharmaceutical Development & Commercialization Inc., of Princeton, N.J., and Click Therapeutics Inc., of New York CT-152 Digital therapeutics Major depressive disorder Started the fully-remote study of up to 540 patients; 10-week study will measure the change from baseline in the Montgomery–Åsberg Depression Rating Scale total score
Regentree LLC, a joint venture of Regenerx Biopharmaceuticals Inc., of Rockville, Md., and Gtreebnt Co. Ltd., of Seongnam, South Korea RGN-259 Thymosin beta 4 ligand Dry eye syndrome Database locked for the Arise-3 study

Notes

For more information about individual companies and/or products, see Cortellis.