Company Product Description Indication Status
Phase I
Acrotech Biopharma LLC, of East Windsor, N.J. Beleodaq (belinostat) Histone deacetylase inhibitor Peripheral T-cell lymphoma Data published in Experimental Hematology and Oncology showed Beleodaq plus cyclophosphamide, doxorubicin, vincristine and prednisone produced an overall response rate of 86%, including 71% complete responses, in the 21 patients treated at the maximum tolerated dose
Biond Biologics Ltd., of Misgav, Israel BND-22 (SAR-444881) Ig-like transcript 2 receptor blocking antibody Advanced solid tumors First patient treated in the dose-escalation study testing the safety, tolerability, pharmacokinetics, antitumor activity and changes in biomarkers for BND-22
Corat Therapeutics GmbH, of Braunschweig, Germany COR-101 Antibody targeting SARS-CoV-2 Hospitalized COVID-19 First patient treated in the study testing the safety and tolerability, as well as the efficacy of COR-101
Imcheck Therapeutics SAS, of Marseille, France ICT-01 Monoclonal antibody targeting BTN3A Solid and hematologic malignancies First patient in the U.S. treated in the ongoing phase I/IIa Eviction study
Niminus Wellness Inc., of Vancouver, British Columbia Psilocybin extraction Psilocybe mushroom product Healthy volunteers (eventually mental health conditions including depression, end of life anxiety and substance use disorders) Partnered with contract research organization KGK Science Inc. to run a study testing the safety and psychoactive properties of the drug in 14 volunteers
Obi Pharma Inc., of Taipei, Taiwan OBI-3424 DNA alkylating agent Relapsed/refractory T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma Started patient enrollment in the phase I/II study; primary endpoint is response rate; secondary endpoints include event-free survival, relapse-free survival and overall survival
Vertex Pharmaceuticals Inc., of Boston VX-548 NaV1.8 inhibitor Visceral and non-visceral types of acute pain Study in healthy volunteers showed the drug had favorable safety, tolerability and pharmacokinetics profiles at doses considerably lower than those required with the company’s previous NaV1.8 inhibitors
Phase II
Biosplice Therapeutics Inc., of San Diego Lorecivivint  CLK/DYRK1A inhibitor Osteoarthritis of the knee Data from the phase IIb study published in Osteoarthritis and Cartilage showed the 0.07-mg and 0.23-mg doses improved pain NRS compared to placebo at week 12 (-0.96, p=0.001 and -0.78, p=0.012, respectively) and at 24 weeks (-0.70, p=0.031 and -0.82, p=0.022, respectively)
Chemomab Therapeutics Ltd., of Tel Aviv, Israel CM-101 Monoclonal antibody targeting CCL24 Nonalcoholic steatohepatitis with fibrosis stage F2-F3 Enrolled first patient in the phase IIa study testing the safety, pharmacokinetics and pharmacodynamic effects, as well as the antifibrotic effects of CM-101
G1 Therapeutics Inc., of Research Triangle Park, N.C. Cosela (trilaciclib) Myelopreservation agent Extensive-stage small-cell lung cancer Pooled results from 3 phase II studies published in Clinical Lung Cancer showed severe neutropenia (SN) in cycle 1 lasted an average of 0 days for patients taking Cosela compared to 4 days for placebo (p<0.0001); throughout the treatment period, 11.4% of patients who received Cosela had SN compared to 52.9% of patients in the placebo group (p<0.0001)
Hemostemix Inc., of Calgary, Alberta ACP-01 Autologous cell therapy Critical limb ischemia Last patient completed their last follow-up visit in the phase II study
I-Mab Biopharma Co. Ltd., of Shanghai Olamkicept (TJ-301) IL-6 inhibitor Ulcerative colitis Olamkicept improved clinical response rate after 12 weeks (p=0.032) and clinical remission and mucosal healing (p<0.001)  compared to placebo; data to be presented at Digestive Disease Week 2021 in May and at the European Crohn's and Colitis Organisation meeting in July
Reviva Pharmaceuticals Holdings Inc., of Cupertino, Calif. RP-5063 (brilaroxazine) Targets serotonin receptors 5-HT1A/2A/2B/7 Acute schizophrenia Brilaroxazine reduced total Positive and Negative Syndrome Scale by 20 points, a statistically significant improvement over placebo
Sirnaomics Inc., of Gaithersburg, Md. STP-705 siRNA knockdown of TGF-beta and COX-2 gene expression Squamous cell skin cancer Started the phase IIb study testing 3 dose levels of STP-705; primary endpoint is histological clearance rate
Vertex Pharmaceuticals Inc., of Boston VX-548 NaV1.8 inhibitor Visceral and non-visceral types of acute pain Plans to start 2 phase II studies in the second half of 2021 in patients with acute pain following bunionectomy surgery or abdominoplasty comparing multiple doses of VX-548 to hydrocodone/acetaminophen; primary endpoint for both studies is the time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment
Phase III
Amgen Inc., of Thousand Oaks, Calif. Otezla (apremilast) Phosphodiesterase 4 inhibitor Mild to moderate plaque psoriasis In the Advance study, 21.6% of patients taking Otezla 30 mg twice daily achieved Physician's Global Assessment response at week 16 compared to 4.1% of patients taking placebo (p<0.0001); 71.7% of patients taking Otezla achieved a body surface area (BSA) of 3% or less compared to 35.8% of patients taking placebo; 29% of patients taking Otezla had at least a 75% improvement in BSA compared to 6.1% of patients taking placebo
Astrazeneca plc, of Cambridge, U.K., and Sanofi SA, of Paris Nirsevimab Monoclonal antibody targeting respiratory syncytial virus Lower respiratory tract infections The Melody study met its primary endpoint of reducing the incidence of medically attended lower respiratory tract infections caused by respiratory syncytial virus compared to placebo; data to be presented at a forthcoming medical meeting
Baudax Bio Inc., of Malvern, Pa. Anjeso (meloxicam) COX-2 inhibitor Pain from unilateral total knee arthroplasty Data published in Pain Medicine showed patients used 31.7% less opioids compared to placebo during the first 24 hours (p<0.0001); Summed Pain Intensity score on the first postsurgical day was 22% lower for Anjeso compared to placebo (p≤0.0001) 
Daré Bioscience Inc., of San Diego DARE-BV1 Thermosetting vaginal gel Bacterial vaginosis In the DARE-BVFREE study, 70% of patients treated with DARE-BV1 were clinically cured compared to 36% of patients taking placebo
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Tremfya (guselkumab) Monoclonal antibody targeting the p19 subunit of IL-23 Moderate to severe plaque psoriasis In the Voyage 2 study, at week 252, 55.5% of patients taking Tremfya achieved an Investigator's Global Assessment score of 0 and 53% achieved a Psoriasis Area Severity Index 100 skin clearance response 
Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson Tremfya (guselkumab) Monoclonal antibody targeting the p19 subunit of IL-23 Psoriatic arthritis In the Discover-1 and -2 studies, at 52 weeks, Tremfya improved composite disease activity scores and Bath Ankylosing Spondylitis Disease Activity Index
Kintor Pharmaceuticals Ltd., off Suzhou, China Proxalutamide  Nonsteroidal antiandrogen Mild or moderate COVID-19 First patient treated in the U.S.; primary endpoint is the percentage of hospitalization events (including death) by day 28; secondary endpoints include proportion of mortality by day 28, percentage of patients achieving each clinical status on days 7, 14 and 28 using National Institute of Allergy and Infectious Diseases 8-point scoring scale

Notes

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