Company Product Description Indication Status
Phase I
Ampio Pharmaceuticals Inc., of Englewood, Colo. I.V. Ampion Stem cell antigen-1 inhibitor COVID-19 I.V. Ampion plus standard of care (SOC) was deemed safe and well-tolerated for 90 days following treatment; improvements on the World Health Organization clinical improvement scale and the National Early Warning Score were better for I.V. Ampion plus SOC compared to SOC; planning to run a phase II study
Galmed Pharmaceuticals Ltd., of Tel Aviv, Israel Aramchol meglumine Liver-targeted SCDI modulator Nonalcoholic steatohepatitis and fibrosis Plasma pharmacokinetics of aramchol meglumine were similar to aramchol acid and both drugs resulted in the same form of aramchol in the blood
Humanigen Inc., of Burlingame, Calif. IfabotuzumabĀ  Monoclonal antibody targeting EphA3 Recurrent glioblastoma multiforme Completed enrollment in the study; data expected in theĀ  first half of 2021
Immunicum AB, of Stockholm Ilixadencel Cell-based, off-the-shelf immune primer Advanced cancer Completed enrollment in the phase Ib portion of the phase Ib/II Iliad study; top-line results expected during the third quarter of 2021
Metacrine Inc., of San Diego MET-642 Farnesoid X receptor agonist Healthy volunteers (eventually nonalcoholic steatohepatitis and inflammatory bowel disease) Drug was well-tolerated with a sustained pharmacokinetic profile and robust FXR target engagement after 14 days of daily oral dosing
Molecular Partners AG, of Zurich-Schlieren, Switzerland MP-0310 (AMG-506) Targets 4-1BB and FAP Advanced solid tumorsĀ  Of the 19 evaluable patients, 50% achieved stable disease; no-dose limiting toxicities
Molecular Partners AG, of Zurich-Schlieren, Switzerland MP-0420 (ensovibep) Targets SARS-CoV-2 spike protein COVID-19 Enrolling second of 3 dosing cohorts; well-tolerated to date; final dosing cohort expected to enroll in the coming weeks; final data expected in the first quarter of 2021
Nextcure Inc., of Beltsville, Md. NC-318 Targets Siglec15 Head and neck squamous cell carcinoma and triple-negative breast cancer 2 objective responders in the phase I portion who have continued on drug for over 104 weeks and over 78 weeks; in phase II portion, Siglec15 only expressed on 13% of tumors of patients enrolled in study; modifying the study to pre-select patients with Siglec15 expression starting in first quarter of 2021
Otonomy Inc., of San Diego OTO-413 Sustained-exposure formulation of brain-derived neurotrophic factor Speech-in-noise hearing difficulty At the highest dose, 6 out of 9 patients treated with OTO-413 had clinically-meaningful improvement on at least one of the 3 speech-in-noise (SIN) tests at both days 57 and 85 compared to 0 out of 8 for placebo; 3 out of 9 patients treated with OTO-413 had a clinically-meaningful improvement by 2 or more different SIN tests at both days 57 and 85 vs. 0 out of 8 for placebo
Vasomune Inc., of Toronto AV-001 Targets Tie2 tyrosine kinase receptor Healthy subjects (eventually COVID-19) First subject dosed in study to test safety, tolerability and pharmacokinetics of daily administration of single and multiple doses of AV-001
Phase II
Aldeyra Therapeutics Inc., OF Lexington, Mass. ADX-629 RASP inhibitor COVID-19 infection Trial expected to randomize about 30 adults to 300 mg of study drug or placebo twice daily for up to 28 days; key endpoints include NIAID COVID-19 scale and plasma levels of cytokines and RASP; enrollment to begin in first quarter of 2021
Aldeyra Therapeutics Inc., OF Lexington, Mass. ADX-629 RASP inhibitor Atopic asthma Crossover trial will randomize 12 people with cat or house dust mite allergen-induced asthma to 600 mg of study drug or placebo twice daily for about 1 week; outcomes include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts and plasma levels of cytokines and RASP; enrollment to begin in first quarter of 2021
Aldeyra Therapeutics Inc., OF Lexington, Mass. ADX-629 RASP inhibitor Psoriasis 10 adults will receive 250 mg of study drug twice daily for up to 90 days; outcomes include psoriasis area and severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge and plasma levels of cytokines and RASP; enrollment to begin in first half of 2021
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia Ifenprodil NMDA receptor antagonist COVID-19 infection Clarified that phase IIb/III trial design was based on WHO guidelines allowing for secondary endpoint to be used as primary endpoint in phase III portion; trial includes multiple FDA-accepted efficacy endpoints, including respiratory failure (including need for mechanical ventilation), need for intensive care or hospitalization, objective measure of sustained improvement such as oxygenation, measures of clinical improvement such as WHO scores, and mortality; consultation with FDA on possible path to EUA expected following final phase IIb data set
Calcimedica Inc., of La Jolla, Calif. Auxora (CM-4620) Ca2+ release activated Ca2+ channel 1 inhibitor Severe COVID-19 pneumonia Following analysis of safety data from 50 participants, DMC recommended trial continue; 100+ projected to be enrolled by year-end 2020, with trial expected to conclude in April 2021
Glaxosmithkline plc, of London Daprodustat HIF-PH inhibitor Anemia in chronic kidney disease Study in patients not on dialysis who are not currently treated with recombinant human erythropoietin drugs terminated due to feasibility in recruitment
Revance Therapeutics Inc., of Newark, Calif. DaxibotulinumtoxinA Botulinum toxin A stimulator Upper facial lines Proportion of subjects achieving score of none or mild wrinkle severity at maximum contraction at week 4 was 95.8% both for glabellar and forehead lines and 91.7% for lateral canthal lines, with median time to loss of none or mild exceeding 24 weeks and median time to return to baseline exceeding 33 weeks
Phase III
Adial Pharmaceuticals Inc., of Charlottesville, Va. AD-04 (repurposed ondansetron)
5-HT3 receptor antagonist
Alcohol use disorder Pivotal Onward trial reached 35% enrollment, with lower early termination rate than expected; no serious adverse events to date
Albireo Pharma Inc., of Boston Odevixibat Ileal bile acid transport inhibitor Alagille syndrome Pivotal Assert trial initiated with goal of enrolling about 45 children ages 0 to 17 years with genetically confirmed disease; primary efficacy endpoint is relief of pruritus, with secondary endpoint of change in serum bile acid levels
Biocardia Inc., of San Carlos, Calif. Cardiamp Autologous bone marrow-derived stem cell therapy Heart failure Following review of data on 86 participants in pivotal study, including 60 who reached 1-year follow-up, DSMB recommended trial continue as designed
Cytodyn Inc., of Vancouver, Washington Leronlimab (PRO-140) CCR5 antagonist Severe to critical COVID-19 Reached full enrollment of registrational trial; 390-patient data will be analyzed in about 28 days, with expected results to be announced shortly thereafter
Eusa Pharma (UK) Ltd., of Hemel Hempstead, U.K. Siltuximab IL-6 receptor antagonist COVID-19-related acute respiratory distress syndrome First hospitalized participant with serious viral ARDS enrolled in pivotal Silvar trial, designed to confirm results from observational Sisco study in 30 treated with siltuximab vs. 30 matched controls
Evofem Biosciences Inc., of San Diego Phexxi (EVO-100, L-lactic acid + citric acid + potassium bitartrate) Vaginal pH regulator Chlamydia; gonorrhea Evoguard trial assessing effectiveness to prevent infection remains on target to complete enrollment of 1,730 participants by year-end 2021
Galmed Pharmaceuticals Ltd., of Tel Aviv, Israel Aramchol Liver-targeted SCDI modulator Nonalcoholic steatohepatitis and fibrosis Added an open-label extension to the Armor study, which will enroll about 150 patients, including those currently enrolled as well as newly recruited patients, who will be randomized to have liver biopsy at 24 weeks, 48 weeks or 72 weeks
Phase IV
Acer Therapeutics Inc., of Newton, Mass. Celiprolol Beta1 blocker with a beta2 agonist vasodilatory Vascular Ehlers-Danlos syndrome Long-term follow-up of 40 patients treated in a retrospective study showed the annual risk of a major vascular event was 4.7%

Notes

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