Company Product Description Indication Status
Phase I
Alladapt Immunotherapeutics Inc., of Menlo Park, Calif. ADP-101   Immunotherapy covering 9 food groups Food allergy First patients treated in the phase I/II Harmony study 
Candel Therapeutics Inc., of Needham, Mass. CAN-2409 Replication-deficient adenovirus expressing herpes simplex virus thymidine kinase Newly diagnosed high-grade glioma Completed enrollment of 35 evaluable patients in the study testing CAN-2409 plus Opdivo (nivolumab) and radiation, as well as temozolomide for patients with methylated MGMT promoters; data expected in 2022
Chimeric Therapeutics Ltd., of Carlton South, Australia CLTX CAR T CAR T using chlorotoxin to target cancer cell Progressive or recurrent glioblastoma All patients in the first cohort have passed the 28-day follow up period without experiencing dose-limiting toxicities; plans to start second dosing level that will include intratumoral and intracranial intraventricular injections at a total dose of 88 x 10^6 CAR T cell
Delpor Inc., of Brisbane, Calif. DLP-114 Long-acting implant containing the atypical antipsychotic risperidone Schizophrenia maintenance therapy Treated first patient in the phase Ib/IIa study testing the use of the implant for 6 or 12 months
Genethon, of Evry, France GNT-0004 Gene therapy expressing micro-dystrophin Duchenne muscular dystrophy First patient treated in the phase I/II/III I-Motion platform study; primary outcome is change in North Star Ambulatory Assessment score at 1 year
Hoth Therapeutics Inc., of New York Biolexa Antimicrobial topical formulation Mild to moderate atopic dermatitis Started the study testing Biolexa in a cohort of healthy volunteers followed by a cohort of patients; primary endpoint is safety and tolerability; efficacy will be measured as secondary endpoints, including change in Eczema Area and Severity Index score and on the Scoring Atopic Dermatitis index
Monopteros Therapeutics Inc., of Boston MPT-0118 MALT1 inhibitor Solid tumors Treated first patient in the phase I/Ib study testing the safety, efficacy and pharmacology of MPT-0118
Organicell Regenerative Medicine Inc., of Miami Zofin  Growth factors, cytokines, chemokines and extracellular vesicles/nanoparticles derived from perinatal tissue Mild to moderate COVID-19 at high risk of progression to moderate disease Completed enrollment in the expanded access trial; initial trial data will start in approximately 75 days; study will conclude in the 3Q of 2021
Protokinetix Inc., of Marietta, Ohio PKX-001 Anti-aging glycopeptide  Type-1 diabetes Resumed studies at the University of Alberta, Edmonton after a pause due to the COVID-19 pandemic
Yumanity Therapeutics Inc., of Boston YTX-7739 Inhibits stearoyl-CoA desaturase Parkinson’s disease In a multiple ascending dose phase Ia study in healthy volunteers, YTX-7739 produced dose-dependent decreases in target fatty acids; the drug was generally well-tolerated; a phase Ib study in patients is ongoing with top-line data expected in mid-2021
Phase II
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson  A3 adenosine receptor agonist Moderate to severe COVID-19 Expanding the phase II study to 2 European countries, Romania and Bulgaria; data expected in the 4Q of 2021
Karolinska Development AB, of Stockholm, Sweeding and its portfolio co. Umecrine Cognition Golexanolone  GABA-A receptor antagonist Liver cirrhosis Data published in the Journal of Hepatology showed golexanolone improved neuropsychiatric performance compared to placebo for Epworth Sleepiness Scale (p=0.047), electroencephalogram mean dominant frequency (p=0.142) and delta+theta/alpha+beta ratio (p=0.021)
Mediwound Ltd., of Yavne, Israel Escharex  Enzymatic debridement agent Lower leg ulcers Enrolled first of up to 15 patients in the study testing the clinical performance, safety and pharmacology effect of Escharex; data expected in the second half of 2021
Onconova Therapeutics Inc., of Newtown, Pa. Rigosertib  Small-molecule RAS mimetic  Recessive dystrophic epidermolysis bullosa-associated locally advanced/metastatic squamous cell carcinoma First of 12 patients treated in the study; primary endpoints are overall response rate and safety and tolerability; secondary endpoints include quality of life and a biomarker analysis
Pharming Group NV, of Leiden, The Netherlands Ruconest C1 esterase inhibitor Acute kidney injury after non-ST elevation myocardial infarction Enrolled first of up to 220 patients; primary endpoint is the peak increase of urinary neutrophil gelatinase-associated lipocalin within 24 hours following treatment; additional endpoints include  incidence of serum creatinine increase within 72 hours after angiography, as well as cardiovascular and renal events and hospitalization related medical resource utilization for 6 months
Relief Therapeutics Holding AG, of Geneva, Switzerland, and Advita Life Science GmbH, of Gundelfingen, Germany RLF-100 (aviptadil) Vasoactive intestinal polypeptide agonist  COVID-19-related acute respiratory distress syndrome First patient expected to enroll next week in the 80-patient study testing the inhaled version of the drug; primary endpoint is the time (up to day 28) from hospitalization to clinical improvement, defined as either alive hospital discharge or a decrease of 2 or more points on the WHO-recommended 9-point ordinal scale of clinical status
SAB Biotherapeutics Inc., of Sioux Falls, S.D. SAB-185 hIgG antibody, purified from the plasma of immunized Tc bovines  Non-hospitalized mild to moderate COVID-19 at risk for disease progression First of 110 patients treated in the phase II/III Activ-2 study testing 2 dose levels of SAB-185; primary endpoints include duration of COVID-19 symptoms and the quantification of viral load at multiple timepoints through day 28
Phase III
Lipidor AB, of Stockholm AKP-02 (calcipotriol + betamethasone, spray formulation) Corticosteroid agonist Psoriasis Registration-based study in India expected to recruit 294 participants with mild to moderate disease on track to begin enrollment in mid-2021, with data expected in first half of 2022
Ortho Dermatologics, unit of Bausch Health Companies Inc., of Laval, Quebec IDP-126 (1.2% clindamycin phosphate + 3.1% benzoyl peroxide + 0.15% adapalene, topical gel) Retinoic acid receptor agonist + antibacterial agent + antibiotic topical agent Acne vulgaris Second pivotal trial in 193 participants confirmed findings of first phase III, meeting co-primary endpoints at week 12 with statistical significance, including absolute change from baseline in inflammatory lesion count (p<0.001), absolute change from baseline in non-inflammatory lesion count (p<0.001) and percentage of people who achieved treatment success (p=0.001)
Shanghai Junshi Biosciences Co. Ltd., of Shanghai Toripalimab PD-1 inhibitor Esophageal squamous cell carcinoma DMC for Jupiter-06 study determined that toripalimab + paclitaxel/cisplatin in first-line advanced disease reached pre-specified primary endpoints of progression-free and overall survival at interim analysis and showed improvement in both measures vs. paclitaxel/cisplatin alone
Valneva SE, of Saint-Herblain, France VLA-2001 Inactivated viral vaccine with CpG 1018 adjuvant COVID-19 infection Pivotal trial initiated in ~4,000 participants; primary endpoint is superiority vs. Vaxzevria (AZD-1222, Astrazeneca plc)
Zogenix Inc., of Emeryville, Calif. Fintepla (fenfluramine)  5-HT 1d/5-HT 2a/5-HT 2c receptor modulator; opioid receptor sigma modulator Lennox-Gastaut syndrome Data in 137 evaluable participants ages 6 to 18 years showed improvement in executive function for study drug (n=92) vs. placebo (n=45), with statistical significance in cognition (27% vs. 13%, respectively, p=0.046) and Global Executive Composite score (25% vs. 11%, p=0.034)

Notes

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