Company Product Description Indication Status
Phase I
Eloxx Pharmaceuticals Inc., of Waltham, Mass. ELX-02 CFTR gene modulator; ribosomal protein modulator Renal insufficiency and nephropathic cystinosis Data published in the Journal of Clinical Pharmacology showed the drug had consistent pharmacokinetic profile across increasing degrees of renal insufficiency with reduced clearance; renal elimination was proportional to eGFR
Evelo Biosciences Inc., of Cambridge, Mass. EDP-1815  Non-live strain of Prevotella histicola Mild and moderate atopic dermatitis Difference between EDP-1815 and placebo at day 56 was 52% for Eczema Area and Severity Index (p=0.062), 65% for Investigator’s Global Assessment times Body Surface Area (p=0.022) and 55% for SCORing Atopic Dermatitis (p=0.043) measurements
Faron Pharmaceuticals Oy, of Turku, Finland Bexmarilimab Monoclonal antibody targeting Clever-1 Advanced cancer Added a fifth cohort of patients with cholangiocarcinoma to part II of the phase I/II Matins study; in part I, high baseline count of the Treg cell marker FOXP3 was associated with a clinical response; high levels of Clever-1 detected in patients' plasma, suggesting increased dosing frequency may be required
Forma Therapeutics Holdings Inc., of Watertown, Mass. FT-7051 CBP/p300 inhibitor Metastatic castration-resistant prostate cancer after progression on at least 1 potent anti-androgen therapy Dosed first patient in study testing the safety and tolerability, preliminary antitumor activity (PSA and radiographic responses) and pharmacokinetics/pharmacodynamics of FT-7051
Jemincare Group, of Nanchang, China JMB-2002 Anti-SARS-CoV-2 neutralizing antibody COVID-19 Started study
Mind Medicine Inc., of Basel, Switzerland MDMA and LSD Psychedelics Healthy subjects Started the 4-period crossover study measuring the subjective and autonomic effects of MDMA and LSD, MDMA alone, LSD alone and placebo
Ocular Therapeutix Inc., of Bedford, Mass. OTX-TIC Travoprost intracameral implant Primary open angle glaucoma or ocular hypertension Treatment lowered intraocular  pressure by 7-11 mm Hg across the 4 treatment groups
Sumitomo Dainippon Pharma Oncology Inc., of Cambridge, Mass. TP-0184 Activin receptor-like kinase 2 and 5 inhibitor Anemia in patients with low or intermediate risk myelodysplastic syndromes Treated first patient in the study designed to determine the maximum tolerated dose or maximum administered dose and the recommended dose for future expansion arms in the phase II part of the study
Phase II
Apnimed Inc., of Cambridge, Mass. AD-109 (atomoxetine + aroxybutynin) Norepinephrine reuptake inhibitor + antimuscarinic Mild to moderate obstructive sleep apnea First of 30 patients treated in the study comparing two doses of AD-109 to placebo in a 3-period crossover study; primary endpoint is change in Apnea-Hypopnea Index
Ocuphire Pharma Inc., of Farmington Hills, Mich. Nyxol  Formulation of phentolamine mesylate Glaucoma and presbyopia Data from the Orion-1 study published in Clinical Ophthalmology showed Nyxol produced a statistically significant 20% mean reduction, or approximately 1 mm in pupil diameter, under daytime and nighttime lighting conditions that was sustained for over 30 hours post-dosing; over 60% of patients treated with Nyxol had a statistically significant improvement of 1-line or greater in near visual acuity compared to 20% of those on placebo
Seneca Biopharma Inc., of Germantown, Md. NSI-566 Human neural stem cell therapy Stable deficits in motor function resulting from ischemic stroke One year after treatment, Fugl-Meyer Motor Score improved by 12.20 points for patients treated with NSI-566 and 6.30 points for those treated with placebo (p=0.231)
Synairgen plc, of Southampton, U.K. SNG-001 Inhaled interferon-beta-1a COVID-19 Completed enrollment of 120 patients in the SG016 study; results expected in the second quarter of 2021
Theralase Technologies Inc., of Toronto TLD-1433 Ruthenium-based photodynamic compound  Non-muscle invasive bladder cancer unresponsive or intolerant to Bacillus Calmette-Guerin Launched study of approximately 100 patients; primary endpoint is rate of complete responders; secondary endpoint is duration of CR at 360 days post-initial CR
Phase III
Tris Pharma Inc., of Monmouth Junction, N.J. Amphetamine extended-release tablet Stimulant Attention deficit hyperactivity disorder Treatment with amphetamine extended-release tablet improved the average Permanent Product Measure of Performance total score over all post dose time points by 302.8 compared to 279.6 points for those treated with placebo (p=0.0043)
Phase IV
Alkermes plc, of Dublin Vivitrol (naltrexone) Opioid receptor antagonist Alcohol use disorder Data from a nationwide register of 125,000 working aged persons living in Sweden published in Addiction showed naltrexone, used either alone or with disulfiram or acamprosate, was associated with a decreased risk of hospitalization due to alcohol use disorder

Notes

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