Company Product Description Indication Status
Phase I
Xeris Pharmaceuticals Inc., of Chicago Xerisol diazepam Benzodiazepine Healthy volunteers (eventually cluster seizures) The 0.25 mg/kg dose had similar Cmax and Tmax as a 0.2 mg/kg dose of Diastat and a higher drug exposure area under the curve over 24 hours; the 0.25 mg/kg and 0.125 mg/kg were overall dose proportional
Phase II
Ascendis Pharma A/S, of Copenhagen, Denmark Transcon PTH Long-acting prodrug of parathyroid hormone Hypoparathyroidism  In the 57-patient per protocol analysis, all patients treated with the highest 21 µg/day dose were able to eliminate standard of care vitamin D and calcium; 82% of patients across all 3 dosing arms were able to eliminate standard of care
Karyopharm Therapeutics Inc., of Newton, Mass. Selinexor Blocks XPO1 Severe COVID-19 Treated first of approximately 230 patients; primary endpoint is improvement in the Ordinal Scale; secondary endpoints include overall survival at day 28 and rate of and time to mechanical ventilation
Phase III
Alexion Pharmaceuticals Inc., of Boston Ultomiris (ravulizumab-cwvz)  C5 complement inhibitor COVID-19 with severe pneumonia or acute respiratory distress syndrome Plans to start a 270-patient study in May 2020 measuring survival, duration of mechanical ventilation and hospital stay compared to best supportive care
Bristol Myers Squibb Co., of New York Opdivo (nivolumab)/Yervoy (ipilimumab) Monoclonal antibodies targeting PD-1 and CTLA-4 Previously untreated malignant pleural mesothelioma In the Checkmate -743 study, combination improved overall survival compared to chemotherapy (pemetrexed and cisplatin or carboplatin); data to be presented at an upcoming medical meeting
Bristol Myers Squibb Co., of New York, Exelixis Inc., of Alameda, Calif., Ipsen SA, of Paris, and Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Opdivo (nivolumab)/Cabometyx (cabozantinib) Monoclonal antibody targeting PD-1/kinase inhibitor Previously untreated advanced or metastatic renal cell carcinoma In the Checkmate -9ER study, combination improved progression-free survival, overall survival and objective response rate compared to Sutent (sunitinib, Pfizer Inc.); data to be presented at an upcoming medical meeting
Idorsia Ltd., of Allschwil, Switzerland Daridorexant Orexin receptor antagonist Insomnia At month 1 and month 3, drug improved sleep onset and sleep maintenance as measured objectively in a sleep lab by polysomnography and also improved subjective total sleep time as measured daily with a patient diary at home; drug also improved daytime performance using the sleepiness domain score from the Insomnia Daytime Symptoms and Impacts Questionnaire
Incyte Corp., of Wilmington, Del. Jakafi (ruxolitinib) JAK1/JAK2 inhibitor COVID-19-associated cytokine storm Started the 400-patient Ruxcovid study; composite primary endpoint is the proportion of patients who die, develop respiratory failure (require mechanical ventilation) or require intensive care unit care by day 29
Novartis AG, of Basel, Switzerland Hydroxychloroquine Inhibits virus entry Hospitalized patients with COVID-19 Plans to begin a 440-patient study within the next few weeks comparing hydroxychloroquine and hydroxychloroquine plus azithromycin to placebo

Notes

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

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