Company Product Description Indication Status
Phase I
Adagio Therapeutics Inc., of Waltham, Mass. ADG-20 Monoclonal antibody targeting the spike protein of SARS-CoV-2 Mild or moderate COVID-19 Started the phase I/II/III Stamp study testing whether ADG-20 can prevent COVID-19-related hospitalizations and death; initial data expected by the end of 2021
Apellis Pharmaceuticals Inc., of Waltham, Mass. Pegcetacoplan Targeted C3 therapy Advanced geographic atrophy secondary to age-related macular degeneration Post hoc analysis of data from 8 patients in the APL2-103 study who have reached 24 months showed growth rate of geographic atrophy lesions in the treated eye was 46% slower than the untreated fellow eye (p=0.007)
Cardiol Therapeutics Inc., of Oakville, Ontario Cardiolrx Cannabidiol  Cardiovascular disease Drug was safe and generally well-tolerated with no serious adverse events; no abnormal electrocardiogram or abnormal laboratory findings after 6 days of dosing; time to maximal blood level in the fed state was in the range of 5 to 7 hours, with a half-life of 26 to 29 hours
Epiendo Pharmaceuticals ehf, of Reykjavik, Iceland EP-395 Non-antibiotic macrolide Chronic airway diseases, including chronic obstructive pulmonary disorder, asthma, bronchiectasis, diffuse pan-bronchiolitis, as well as other inflammatory disorders Dosed first healthy subject in the single and multiple ascending-dose study testing the safety and tolerability and pharmacokinetic properties of EP395
Iterion Therapeutics Inc., of Houston Tegavivint Nuclear beta-catenin inhibitor Desmoid tumors No dose-limiting toxicities or significant adverse events were observed
Lindis Biotech GmbH, of Munich, Germany Catumaxomab Bispecific antibody targeting EpCAM and immune cells Non-muscle-invasive bladder cancer Treated first of up to 30 patients in the study; primary endpoints are dose limited toxicity and 1-year recurrence rate; interim analysis expected in the fall of 2021
Longeveron Inc., of Miami Lomecel-B Allogeneic bone marrow-derived medicinal signaling cell Mild Alzheimer’s disease Mini Mental State Exam at 13 weeks for the low dose was 2.69 points better than placebo (p=0.0182); at 26 weeks, Quality of Life in Alzheimer Disease for the low dose was 3.85 points better than placebo (p=0.0444); at 26 weeks, Alzheimer's Disease Cooperative Study Activities of Daily Living for the low dose was 6.95 points better than placebo (p=0.0118)
Peptilogics Inc., of Pittsburgh PLG-0206 Anti-infective peptide Prosthetic joint infections Drug demonstrated a positive safety profile and favorable pharmacokinetics
Prexa Sante LLC, of Los Angeles Product-118 Prexablu drug-device COVID-19 Drug eradicated the virus after 3 daily doses
Synlogic Inc., of Cambridge, Mass. SYNB-1618  Synthetic biotic that consumes phenylalanine Phenylketonuria  In healthy volunteers, the drug reduced the increase of plasma D5-Phe following an oral dose of the tracer in a dose-dependent manner; there was evidence of activity in the fasted state
Phase II
Atriva Therapeutics GmbH, of Tübingen, Germany ATR-002 MEK inhibitor COVID-19 infection First of 220 adults hospitalized with moderate to severe infection dosed in Respire trial assessing clinical severity status at day 15
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Zealand Pharma A/S, of Copenhagen BI-456906 GLP-1/glucagon dual agonist Nonalcoholic steatohepatitis; obesity Trials initiated by BI in each indication
Kinarus AG, of Basel, Switzerland KIN-001 p38 MAPK inhibitor + undisclosed generic drug COVID-19 infection First of about 400 hospitalized participants dosed, with primary endpoints of need for intubation and/or high pressure oxygen and mortality; first interim analysis expected on about 40 people, projected for fourth quarter of 2021, with final results in first quarter of 2022
Mei Pharma Inc., of San Diego, and Kyowa Kirin Co. Ltd., of Tokyo Zandelisib (formerly ME-401) PI3K-delta inhibitor Follicular lymphoma Enrollment of primary efficacy population of 91 participants reached in Tidal study, with top-line data on track to report in fourth quarter of 2021
Merck KGaA, of Darmstadt, Germany Berzosertib Serine threonine protein kinase ATR inhibitor Small-cell lung cancer Cancer Cell published data from NCI-led study showing combination with topotecan resulted in objective response rate of 36% among 25 evaluable participants with relapsed disease; median progression-free survival (PFS) was 4.8 months, with PFS rates at 4 and 6 months of 60% and 36%, respectively; Merck enrolled first of about 80 participants in additional phase II to assess berzosertib in combination with topotecan to treat relapsed, platinum-resistant SCLC 
Nasus Pharma Ltd., of Tel Aviv, Israel FMXIN-001 (naloxone hydrochloride) Opioid receptor antagonist Opiate overdose Pivotal, single-dose bioequivalence study in 42 healthy volunteers showed FMXIN-001 4 mg microspheres powder was absorbed faster into blood than Narcan (naloxone) 4 mg/0.1 ml nasal spray, with AUC of 163% measured 4 minutes after inhalation of FMXIN-001 vs. Narcan (p=0.005), 125% after 10 minutes (p=0.047) and 113% between 10 and 30 minutes (p=0.01); NDA submission expected by year-end 2021
Rigel Pharmaceuticals Inc., of South San Francisco Fostamatinib SYK inhibitor COVID-19 infection Trial in hospitalized participants met primary endpoint of safety and reduced incidence of serious adverse events (SAEs), with 3 SAEs by day 29 for 30 people in study drug + standard of care (SOC) group vs. 6 SAEs for 29 in placebo + SOC group (p=0.23); reduction in hypoxia seen for study drug vs. placebo, at 1 vs. 3, respectively (p=0.29)
Phase III
Akari Therapeutics plc, of London Nomacopan Complement C5 inhibitor; leukotriene BLT antagonist Bullous pemphigoid Pivotal trial initiated, with enrollment of people with moderate to severe disease expected to begin in mid-2021; primary endpoint is disease remission on minimal oral corticosteroids
Bausch + Lomb, unit of Bausch Health Cos. Inc., of Laval, Quebec NOV-03 (perfluorohexyloctane) Ophthalmic liquid formulation Dry eye disease Gobi trial met co-primary endpoints of statistically significant change from baseline in total corneal fluorescein staining at day 15 (p=0.001, secondary endpoint), with continued results through day 57 vs. control (p< 0.001, primary endpoint) and statistically significant change from baseline in dryness score at day 15 (p=0.009, secondary endpoint), with continued results through day 57 vs. control (p<0.001, primary endpoint)
Geron Corp., of Foster City, Calif. Imetelstat Telomerase inhibitor Myelofibrosis First of about 320 participants with disease refractory to JAK inhibitor dosed in ImpactMF trial; primary endpoint is overall survival, with interim analysis at 70% of projected events expected in 2024 and final analysis in 2025
Otsuka Pharmaceutical Co. Ltd., of Tokyo, and H. Lundbeck A/S, of Valby, Denmark Brexpiprazole Partial serotonin 5-HT1A/dopamine D2 agonist; serotonin 5-HT2A antagonist Agitation Enrollment of participants with Alzheimer's-type dementia to continue, based on interim analysis supporting progression to full enrollment of 330 people
Vallon Pharmaceuticals Inc., of Philadelphia Adair (dexamfetamine immediate-release abuse deterrent) Synaptic vesicular amine transporter stimulator; trace amine associated receptor 1 agonist Attention deficit hyperactivity disorder; narcolepsy Ongoing pivotal 4-way crossover Seal study assessing pharmacodynamics, pharmacokinetics, safety and tolerability on target to report data in second half of 2021, with potential NDA filing in second quarter of 2022
Valneva SE, of Saint-Herblain, France VLA-1553 Live attenuated viral vaccine Chikungunya virus infection Enrollment of 4,131 adults completed in pivotal trial, with top-line data expected in mid-2021; antibody persistence trial initiated to track immunogenicity subset for 5 years

Notes

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