Company Product Description Indication Status
Phase I
Aslan Pharmaceuticals Ltd., of Singapore ASLAN-004 Fully human monoclonal antibody that targets the IL-13 receptor α1 subunit Atopic dermatitis Enrollment in second cohort completed
Onconova Therapeutics Inc., of Newtown, Pa. ON-123300 CDK4/6 + ARK5 inhibitor Various cancers Trial begun in China by partner Hanx Biopharmaceuticals Inc.
Trevena Inc., of Chesterbrook, Pa. TRV-250 G protein-selective delta receptor agonist Migraine Well-tolerated up to 30 mg with an appropriate pharmacokinetic profile
Phase II
Bridgebio Pharma Inc., of Palo Alto, Calif Encaleret (CLTX-305) Calcium-sensing receptor antagonist Autosomal dominant hypocalcemia type 1 Started study of up to 16 patients testing  safety, tolerability, pharmacodynamics, pharmacokinetics and efficacy of single and multiple doses of encaleret; top-line data expected in 2021
Leap Therapeutics Inc., of Cambridge, Mass., and Beigene Ltd., of Beijing DKN-01 and tislelizumab Anti-Dickkopf-1 antibody and anti-PD-1 antibody Gastric or gastroesophageal junction cancer First patient dosed in the phase IIa Distinguish study testing the drugs with or without chemotherapy; part A will include up to 24 first-line patients; concurrent part B will include up to 48 second-line patients
Lipocine Inc., of Salt Lake City LPCN-1144 Oral prodrug of testosterone Non-cirrhotic nonalcoholic steatohepatitis Last patient enrolled in the Lift study; top-line readout of the primary endpoint, change in liver fat data measured by MRI-PDFF, expected in January 2021
Mimedx Group Inc., of Marietta, Ga. Micronized dehydrated human amnion chorion membrane  Injectable wound care product  Osteoarthritis of the knee Completed enrollment in the 466-patient study ahead of schedule
Tracon Pharmaceuticals, of San Diego, Alphamab Oncology Co. Ltd., of Suzhou, China, and 3D Medicines Co. Ltd., of Chengdu, China Envafolimab  Single-domain antibody targeting PD-L1 Microsatellite instability-high/deficient mismatch repair colorectal cancer Objective response rate was 32% in 41 patients; 12-month overall survival was 65%
Phase III
Agios Pharmaceuticals Inc., of Cambridge, Mass. Tibsovo (ivosidenib) Isocitrate dehydrogenase-1 inhibitor Cholangiocarcinoma with an isocitrate dehydrogenase 1 mutation In the Clarldhy study, overall survival was longer for patients treated with Tibsovo compared to placebo, but result wasn't statistically significant; crossover to drug was allowed after radiographic disease progression on placebo; plans to submit a supplemental NDA in the first quarter of 2021 and present data at a future medical meeting
Astrazeneca plc, of Cambridge, U.K. AZD-1222 Non-replicating ChAdOx1 Vector
Vaccine
COVID-19 prophylaxis Released protocol of study; primary endpoint is SARS-CoV-2 RT-PCR-positive symptomatic illness occurring ≥ 15 days post second dose of study intervention; 1 interim analysis after 75 events have been reported; primary efficacy endpoint after 150 events
Axsome Therapeutics Inc., of New York AXS-12 Norepinephrine reuptake inhibitor Narcolepsy Following a meeting with the FDA, company plans to run a pivotal study in the first quarter of 2021 to support the NDA; existing short-term and long-term safety database of more than 2,500 patients treated with reboxetine will support NDA
Macrogenics Inc., of Rockville, Md., and Incyte Corp., of Wilmington, Del. Retifanlimab (MGA-012) Anti-PD-1 monoclonal antibody Metastatic squamous and nonsquamous non-small-cell lung cancer Started study testing retifanlimab plus platinum-based chemotherapy
Retrophin Inc., of San Diego Sparsentan  Endothelin receptor type A and angiotensin receptor blocker IgA nephropathy Enrolled 280 of 380 expected patients in the Protect study; prespecified analysis of change in proteinuria in the first 280 patients expected in the third quarter of 2021
Phase IV
Seqirus Inc., of Summit, N.J. aTIV MF59 adjuvanted trivalent influenza vaccine Influenza prophylaxis Using data from the 2017/18 U.S. influenza season in Iqvia's Integrated Data Warehouse, researchers showed aTIV was significantly more effective in preventing influenza-related medical office visits and influenza-related hospitalization/ER visits compared to quadrivalent standard dose influenza vaccine and standard-dose trivalent influenza vaccine, and comparably effective to high-dose trivalent influenza vaccine

Notes

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

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