Company Product Description Indication Status
Phase I
Abbvie, Inc., of North Chicago, Amgen Inc., of Thousand Oaks Calif., and Takeda Pharmaceutical Co. Ltd., of Tokyo Cenicriviroc, Otezla (apremilast) and Firazyr (icatibant) CCR2 and CCR5 receptor antagonist, PDE4 inhibitor and bradykinin B2 receptor antagonist COVID-19 First patient enrolled in the I-Spy COVID study to test drugs in severely ill, hospitalized patients who require high-flow oxygen
Active Biotech, of Lund, Sweden Tasquinimod  Immunomodulatory and anti-angiogenic Relapsed or refractory multiple myeloma First of up to 54 patients treated in the study testing tasquinimod as a monotherapy and in combination with ixazomib, lenalidomide and dexamethasone; primary objective is to establish the optimal dose and treatment schedule; preliminary antimyeloma activity will also be measured
Aileron Therapeutics, of Watertown, Mass. ALRN-6924 Inhibitor of MDM2 and MDMX Chemotherapy-induced bone marrow toxicities Completed enrollment in the phase Ib study; data expected in fourth quarter of 2020
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-151 (topical roflumilast cream) PDE4 inhibitor Chronic plaque psoriasis Phase I/IIa data published in The Journal of Drugs in Dermatology showed the 0.5% and 0.15% dose improved Target Plaque Severity Score and Target Plaque Area at week 4 compared to vehicle (p=0.0007 and p=0.0011, respectively)
Innovent Biologics, Inc., of Suzhou, China IBI-322 Anti-CD47/PD-L1 bispecific antibody Advanced malignancies Treated first patient in China; primary endpoints are safety, tolerability and initial antitumor efficacy of IBI-322
Kadimastem Ltd., of Ness Ziona, Israel Astrorx  Astrocytes derived from human embryonic stem cells Amyotrophic lateral sclerosis In cohorts A and B of phase I/IIa trial, rate of ALS Functional Rating Scale-Revised disease progression declined by more than 50% after treatment compared to 3 months before
Phase II
Biohaven Pharma, of New Haven, Conn. Verdiperstat  Inhibitor of myeloperoxidase Amyotrophic lateral sclerosis Enrolled first of approximately 160 patients in the perpetual phase II/III Healey ALS Platform Trial; primary endpoint is change in disease severity from baseline to week 24 on the ALS Functional Rating Scale-Revised; secondary endpoints include change in respiratory function, muscle strength and survival
Immunic Inc., of New York IMU-838  DHODH inhibitor Relapsing-remitting multiple sclerosis In the Emphasis study, 45 mg and 30 mg of IMU-838 reduced the cumulative number of combined unique active magnetic resonance imaging lesions by 62% and 70%, respectively, compared to placebo (p=0.0002 and p<0.0001, respectively)
Lipocine Inc., of Salt Lake City LPCN-144 Prodrug of testosterone Nonalcoholic fatty liver disease in hypogonadal males Data published in Hepatology Communications showed NAFLD resolved in 33% of patients at 8 weeks and 48% of patients after 16 weeks
Phase III
Akebia Therapeutics Inc., of Cambridge, Mass. Vadadustat Oral hypoxia-inducible factor prolyl hydroxylase inhibitor Anemia due to chronic kidney disease Database locked for Pro2tect cardiovascular outcomes program; top-line data expected in early September 2020
Cymabay Therapeutics Inc., of Newark, Calif. Seladelpar Selective PPAR-delta agonist Primary biliary cholangitis Top-line results from Enhance study showed 78.2% of patients on 10-mg seladelpar vs. 12.5% on placebo achieved primary composite outcome after only 3 months (p<0.0001); 27.4% of treated patients vs. 0 on placebo had normalized serum alkaline phosphatase level by 3 months (p<0.0001); statistically significant improvement in pruritis (p<0.05) for patients with moderate to severe itch; 52-week study was terminated early, prompting amendment to primary outcome measure to 3-month timepoint, which was reached by 167 of 265 patients
Eli Lilly and Co., of Indianapolis, and Abcellera Inc., of Vancouver, British Columbia LY-CoV555 Antibody COVID-19 In collaboration with U.S. National Institute of Allergy and Infectious Diseases started study to enroll up to 2,400 participants at long-term care facilities in U.S., to assess drug’s ability to prevent infection of residents and staff exposed to SARS-CoV-2
Genmab A/S, of Copenhagen, and Janssen Research & Development LLC, part of New Brunswick, N.J.-based Johnson & Johnson Subcutaneous daratumumab CD38-directed monoclonal antibody Relapsed/refractory multiple myeloma  Results showed Apollo study testing combination with pomalidomide and dexamethasone in patients previously treated with lenalidomide and a proteasome inhibitor met primary endpoint of improving progression-free survival; safety profile of combination consistent with safety profile for each therapy separately
Myokardia Inc., of Brisbane, Calif. Mavacamten Oral, allosteric modulator of cardiac myosin Obstructive hypertrophic cardiomyopathy First patient dosed in Valor-HCM trial to enroll participants who have been referred for septal reduction therapy (SRT) and are refractory to current therapeutics options, including those who have severe symptoms (NYHA Class IV); study designed to test drug’s ability to mitigate need for invasive SRT procedures
Polyphor AG, of Allschwil, Switzerland Balixafortide CXCR4 chemokine antagonist Breast cancer In second prespecified interim analysis, independent data safety monitoring board recommended continuation without modification of Fortress study enrolling those with HER2-negative, locally recurrent or metastatic disease

Notes

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

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