Company Product Description Indication Status
Phase I
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia AP-188 (repurposed N,N-dimethyltryptamine) Psychedelic tryptamine compound Stroke Selected Hammersmith Medicines Research Ltd., of London, as contract research organization for study designed to establish dosing regimen
Aslan Pharmaceuticals Ltd., of Singapore
ASLAN-004 
Dual IL-13/IL-4 receptor antagonist Atopic dermatitis Interim data from 3 dose cohorts in ongoing study showed 74% average reduction in EASI from baseline at therapeutic doses (400 mg and 600 mg) after 8 weeks vs. 42% for placebo; 89% of participants achieved EASI-50 and 56% achieved EASI-90
Bioinvent International AB, of Lund, Sweden, and Transgene SA, of Strasbourg, France BT-001  Dual mechanism anti-CTLA4 antibody Solid tumors First participant enrolled in phase I/IIa trial; part A of phase I evaluating study drug as monotherapy in 36 people with advanced/metastatic disease and part B in combination with anti-PD-1 Keytruda (pembrolizumab, Merck & Co. Inc.) in 12 people; phase lla will evaluate combination in several tumor types
Innovent Biologics Inc., of Suzhou, China IBI-322 Anti-CD47/PD-L1 bispecific antibody Advanced solid tumors First participant dosed in phase Ia U.S. study
Morphic Therapeutic Inc., of Waltham, Mass. MORF-057 Integrin alpha-4/beta-7 antagonist Inflammatory bowel disease Study drug well-tolerated in 5 dose cohorts ranging from 25 mg to 400 mg and achieved >95% mean receptor occupancy of alpha-4/beta-7 at 3 highest doses
Samsung Bioepis Co. Ltd., of Incheon, South Korea SB-17 (ustekinumab biosimilar) Dual IL-12/IL-23 receptor antagonist Not disclosed First of 201 healthy male participants dosed in trial evaluating single dose vs. EU- or U.S.-sourced Stelara (ustekinumab, Janssen Biotech)
Santhera Pharmaceuticals Holding AG, of Pratteln, Switzerland lonodelestat Leukocyte elastase inhibitor Cystic fibrosis In all 4 cohorts (80 mg once daily, 80 mg twice daily, 160 mg once daily, 40 mg once daily) of phase Ib trial, transient, near complete inhibition of elastase activity seen after inhalation; some in 40-mg cohort gradually developed constant level of near complete inhibition over 28 days of drug inhalation
Takis Biotech Srl, of Rome COVID-eVax COVID-19 spike glycoprotein modulator COVID-19 infection First of 80 healthy volunteers dosed in phase I study evaluating 4 groups using different doses administered with or without booster; phase II portion will enroll up to 240 people on most promising doses
Phase II
Accure Therapeutics SL, of Barcelona ACT-01 Dual TrkA/TrkB receptor agonist Acute optic neuritis First of 36 participants enrolled in Acuity trial; efficacy measures include change in thickness of retinal layers and clinical vision parameters; results expected in second half of 2022
Annexon Inc., of South San Francisco ANX-007 Complement C1q subcomponent inhibitor Geographic atrophy Dosing initiated in Archer study; efficacy measures include reduction in area of GA as evaluated by fundus autofluorescence
Ocular Therapeutix Inc., of Bedford, Mass. OTX-DED (dexamethasone intracanalicular ophthalmic insert) Glucocorticoid receptor agonist Dry eye disease First of about 150 participants dosed in trial evaluating bulbar conjunctival hyperemia, corneal fluorescein staining eye dryness symptoms using visual analog scale and other efficacy endpoints vs. matched vehicle control hydrogel insert
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y. REGN-1908-1909 Fel d 1 antibody cocktail Cat allergy Single administration controlled response to cat allergen in people with mild asthma, extended primary endpoint of median time to early asthma reaction (>4 hours) vs. placebo (51 minutes) at all measured time points, including at week 1 (p=0.0083); study drug prevented 68% of lung function decline following cat allergen exposure vs. 23% for placebo
Vascular Biogenics Ltd. (VBL Therapeutics), of Tel Aviv, Israel Ofranergene obadenovec (VB-111) CD95 modulator; TNF receptor modulator Glioblastoma First participant enrolled in trial assessing people with recurrent disease scheduled to undergo second surgery; efficacy measures include progression-free survival at 6 months, overall survival, intra-tumoral activity and immune system effect
Phase III
Satsuma Pharmaceuticals Inc., of South San Francisco STS-101 (dihydroergotamine nasal powder) 5-HT 1d receptor agonist Migraine New trial, planned to start in mid-2021 with top-line results expected in second half of 2022, will take into account findings from pivotal Emerge trial that missed co-primary endpoints; dose strengths greater than 5.2 mg first will be explored in phase I trial in second quarter of 2021, evaluating pharmacokinetics, safety and tolerability to select phase III dose

Notes

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