Company Product Description Indication Status
Phase I
Bio-Thera Solutions Ltd., of Guangzhou, China BAT-2206 Biosimilar of Stelara (ustekinumab) Healthy volunteers Started single-dose study comparing drug to U.S.- and EU-sourced reference product in 270 participants
Celecor Therapeutics Inc., of San Diego RUC-4 GPIIb/IIIa inhibitor Coronary artery disease Data published in the Journal of the American Heart Association showed the drug produced high‐grade (>80%) platelet inhibition that resolved within 2 hours in 14 healthy volunteers and 30 stable patients taking aspirin
Exact Therapeutics A/S, of Oslo, Norway Acoustic Cluster Therapy (ACT) Microbubbles and microdroplets activated with ultrasound  Metastatic colorectal cancer Enrolled first patient in the Activate study following temporary suspension due to the COVID-19 pandemic
Lattice Biologics Ltd., of Belgrade, Mont. Amnioboost  Concentrated allogeneic mesenchymal stem cells and cytokines derived from amniotic fluid Acute respiratory distress syndrome due to COVID-19 Stopped study due to lack of patient recruitment with appropriate acceptance criteria
Novavax Inc., of Gaithersburg, Md. NVX‑CoV2373 Nanoparticle vaccine with the spike protein of SARS-CoV-2 and Matrix-M adjuvant COVID-19 prophylaxis Data published in The New England Journal of Medicine showed all participants generated neutralizing antibodies after the second dose; Matrix-M helped the 5-µg dose perform comparably with the 25-µg dose
Sanofi SA, of Paris, and Glaxosmithkline plc, of London Adjuvanted COVID-19 vaccine Protein-based vaccine plus a pandemic adjuvant COVID-19 prophylaxis Started the phase I/II study in 440 participants; initial data expected in December 2020
Sutro Biopharma Inc., of South San Francisco STRO-002 Antibody-drug conjugate targeting folate receptor alpha Varian and endometrial cancer Partial response was seen in 5 of 29 evaluable patients with 2 confirmed on second scan; 9 patients have stable disease
Phase II
89bio Inc., of San Francisco BIO89-100 Glycopegylated analogue of fibroblast growth factor 21 Severe hypertriglyceridemia Started study of about 90 patients comparing 4 treatment regimens to placebo; primary endpoint is the reduction in fasting triglycerides from baseline; secondary endpoints include the effect on other lipids and metabolic markers and change in liver fat
Auris Medical Holding Ltd., of Hamilton, Bermuda AM-125 Intranasal betahistine Vertigo following neurosurgery In part A of the study, AM-125 improved Tandem Romberg from baseline to 14 days post-surgery by 6 seconds compared to 3.1 seconds for placebo and improved the Standing on Foam test by 10.5 seconds compared to 4.3 seconds for placebo; all active dose groups were statistically significant (p<0.02 and p<0.01 to p<0.05, respectively)
Hutchison China Meditech Ltd., of Hong Kong HMPL-453 Fibroblast growth factor receptor inhibitor Advanced intrahepatic cholangiocarcinoma with FGFR2 fusion after failure of at least 1 systemic therapy Started study measuring objective response rate; secondary endpoints include disease control rate, time to response, duration of response, progression-free survival and overall survival
Incyte Corp., of Wilmington, Del. Tabrecta (capmatinib) Met inhibitor Metastatic non-small-cell lung cancer with MET exon 14 skipping mutations Data from the Geometry mono-1 study published in The New England Journal of Medicine showed overall response rate was 68% for 28 treatment-naïve patients and 41% for 69 previously treated patients; 7 of 13 evaluable patients with brain metastases had intracranial responses, including 4 complete responses
Phase III
Akebia Therapeutics Inc., of Cambridge, Mass.,  Vadadustat Hypoxia-inducible factor prolyl hydroxylase inhibitor Anemia due to chronic kidney disease In the Pro2tect study, vadadustat was noninferior to darbepoetin alfa as measured by a mean change in hemoglobin between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52); study didn't meet the primary safety endpoint of noninferiority of vadadustat vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events
Madrigal Pharmaceuticals Inc., of Conshohocken, Pa. Resmetirom (MGL-3196) Thyroid hormone receptor-beta agonist Nonalcoholic fatty liver disease Exceeded enrollment target of 700 patients in the Maestro NAFLD-1 study; top-line data expected by the end of 2021
Novan Inc., of Morrisville, N.C. SB-206 Antiviral gel Molluscum contagiosum Treated first patient in the B-Simple4 study; top-line data expected in the second quarter of 2021
Octapharma USA Inc., of Paramus, N.J. Panzyga (immune globulin intravenous, human) Liquid preparation of immune globulin Pediatric acute-onset neuropsychiatric syndrome Launched study to compare Panzyga vs. placebo for reducing the severity of symptoms associated with PANS; secondary objectives are to determine sustainability of the reduction of the severity of symptoms and to assess efficacy in reducing functional impairment associated with PANS
Tonix Pharmaceuticals Holding Corp., of New York TNX-102 SL (cyclobenzaprine sublingual tablets) Non-opioid, centrally acting analgesic Fibromyalgia Enrolled first of about 470 patients in the Rally study; primary endpoint is daily diary pain severity score change from baseline

Notes

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