Company Product Description Indication Status
Phase I
Heat Biologics Inc., of Durham, N.C. HS-130 Engineered to secrete OX40L-Fc fusion protein Advanced solid tumors First patient dosed
Meiji Seika Pharma Co. Ltd., of Tokyo DMB-3115 Biosimilar ustekinumab (Stelara, Johnson & Johnson), a recombinant immunoglobulin G1kappa monoclonal antibody targeting IL-12 and IL-23 Crohn's disease Trial begun
Wave Life Sciences Ltd., of Cambridge, Mass. Suvodirsen Stereopure oligonucleotide Duchenne muscular dystrophy Interim analysis showed no change from baseline in dystrophin expression; development discontinued
Phase II
Arcutis Biotherapeutics Inc., of Westlake Village, Calif. ARQ-151, roflumilast Phosphodiesterase type 4 inhibitor Plaque psoriasis and atopic dermatitis On the study’s primary endpoint, the mean reduction in the Eczema Area and Severity Index Total Score after 4 weeks of once-daily treatment, neither dose reached statistical significance vs. vehicle
Gilead Sciences Inc., of Foster City, Calif. Firsocostat, selonsertib and cilofexor Acetyl-CoA carboxylase inhibitor, ASK1 inhibitor and nonsteroidal farnesoid X receptor agonist Nonalcoholic steatohepatitis In the Atlas study, primary endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH was not met for any of the treatment arms; combination of firsocostat plus cilofexor performed best with 20.9% of the 67 patients meeting the endpoint, compared to 10.5% of 38 patients taking placebo (p=0.17)
Phase III
Axsome Therapeutics Inc., of New York AXS-05  NMDA receptor antagonist Major depressive disorder In the 327-patient Gemini study, treatment with drug for 6 weeks reduced the Montgomery-Åsberg Depression Rating Scale total score by 16.6 points, compared to an 11.9-point reduction for placebo (p=0.002); rates of remission from depression were 39.5% for AXS-05 compared to 17.3% for placebo (p<0.001)
Beigene Co. Ltd., of Beijing Brukinsa (zanubrutinib) BTK inhibitor Waldenström’s macroglobulinemia  In the Aspen study, relapsed or refractory patients had a very good partial response (VGPR) rate of 28.9% in the zanubrutinib arm and 19.8% in the ibrutinib arm (p=0.1160); overall population had VGPR rates of 28.4% for zanubrutinib and 19.2% for ibrutinib (p=0.0921)
Biomarin Pharmaceutical Inc., of San Rafael, Calif. Vosoritide Targets NPR-B Achondroplasia Drug produced a placebo-adjusted change from baseline in growth velocity after 1 year of 1.6 cm/yr (p<0.0001)
Novartis AG, of Basel, Switzerland Fevipiprant (QAW-039) DP2 receptor antagonist Moderate-to-severe asthma Pooled data from the Luster-1 and Luster-2 studies didn't meet the clinically relevant threshold for reduction in rate of moderate-to-severe exacerbations compared to placebo over the 52-week treatment period for either of the doses; data to be published at an upcoming medical meeting

Notes

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

No Comments