Company |
Product |
Description |
Indication |
Status |
Phase I | ||||
Alligator Bioscience AB, of Lund, Sweden |
ATOR-1015 |
Next generation CTLA-4 bispecific antibody |
Advanced solid tumors |
First patient dosed in dose-escalation study in up to 53 patients; primary aim will test safety and tolerability and identify recommended phase II dose; results expected in the second half of 2020 |
Arqule Inc., of Burlington, Mass. |
ARQ-531 |
Reversible dual inhibitor of wild-type and C481S-mutant BTK |
Chronic lymphocytic leukemia |
Company disclosed in its earnings call the first evaluable patient with C481S mutation dosed in cohort 7 (65 mg QD) achieved an 88% tumor burden reduction after the first scan |
Boehringer Ingelheim GmbH, of Ingelheim, Germany |
BI-655130 |
IL-36R-blocking monoclonal antibody |
Generalized pustular psoriasis |
Data published in The New England Journal of Medicine showed rapid improvement in symptoms in 7 patients experiencing acute moderate or severe disease flares; 5 of 7 patients in the 20-week study achieved clear or almost clear skin within the first week, following single-dose treatment, and all achieved that outcome after 4 weeks; average improvement in skin symptoms was close to 80% at week 4 and was maintained until end of study |
Forendo Pharma Oy, of Turku, Finland |
FOR-6219 |
HSD17B1 inhibitor |
Endometriosis |
Completed a phase Ia study showing single doses from 2 mg up to 175 mg and multiple doses up to 150 mg twice daily for 10 days were found to be safe and well-tolerated; data support initiation of phase Ib trial in healthy premenopausal women |
Kezar Life Sciences Inc., of South San Francisco |
KZR-616 |
Immuno-proteasome inhibitor |
Lupus nephritis |
Started randomized, double-blind, placebo-controlled single and multiple ascending-dose trial to test safety, tolerability, pharmacokinetics and target inhibition using simplified lyophilized formulation in up to 72 healthy female subjects |
Phase II | ||||
Gilead Sciences Inc., of Foster City, Calif. |
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) |
HIV-1 integrase/nucleoside reverse transcriptase inhibitor |
HIV-1 |
Through week 48 of phase II/III study, 98% (n=74/75) of virologically suppressed individuals ages 6 to 18 (n=100) living with HIV maintained undetectable viral load, and none developed treatment-emergent resistance |
Opthea Ltd., of Melbourne, Australia |
OPT-302 |
Soluble form of VEGFR3 |
Wet age-related macular degeneration |
Independent data safety and monitoring board for ongoing phase IIb study reaffirmed for the second time its positive recommendation the trial continue without modification |
Sanbio Group, of Mountain View, Calif. |
SB-623 |
Cell therapy |
Traumatic brain injury |
Results from STEMTRA study showed primary endpoint was achieved, with the treatment group demonstrating statistically significant improvement in motor function vs. control group |
Sound Pharmaceuticals Inc., of Seattle |
SPI-1005 |
Mimics and induces glutathione peroxidase activity |
Meniere's disease |
Completed enrollment in phase IIb trial |
Zynerba Pharmaceuticals Inc., of Devon, Pa. |
Zygel (ZYN-002) |
CBD gel |
Autism spectrum disorder |
Started 14-week, open-label BRIGHT study to assess safety, tolerability and efficacy in about 36 children and adolescents; top-line data expected in the first half of 2020 |
Phase III | ||||
Allergan plc, of Dublin |
Rapastinel |
Selective positive NMDA receptor modulator |
Major depressive disorder |
Top-line results from 3 pivotal studies as an adjunctive treatment showed rapastinel arms did not differentiate from placebo on primary and key secondary endpoints; an interim analysis of a separate relapse prevention study suggests primary and key secondary endpoints will not be met |
Bioarctic AB, of Stockholm |
BAN-2401 |
Amyloid beta-targeting monoclonal antibody |
Early Alzheimer's disease |
Partner Eisai Co. Ltd. said confirmatory phase study will be initiated in March 2019, with final readout of primary endpoint in 2022 |
Gilead Sciences Inc., of Foster City, Calif. |
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) |
HIV-1 integrase/nucleoside reverse transcriptase inhibitor (NRTI) |
HIV-1 |
2 studies of resistance profile in virologically suppressed adults switching from dolutegravir/abacavir/lamivudine or boosted protease inhibitor found high rates of virologic suppression with Biktarvy in treatment-experienced adults (n=561/570; 98%), including those with pre-existing resistance to NRTIs (n=155/159; 97%); none developed treatment-emergent resistance during studies |
Gilead Sciences Inc., of Foster City, Calif. |
Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) |
HIV-1 integrase/nucleoside reverse transcriptase inhibitor |
HIV-1 |
Ongoing study evaluating 565 virologically suppressed adults who switched 1-to-1 from regimen of DTG+F/TAF or DTG+F/TDF to DTG+F/TAF or Biktarvy for 48 weeks found 99% (n=557/562) of those with a post-baseline visit and 99% (n=220/222) of those with resistance to any class of antiretroviral had undetectable viral load (HIV-1 RNA <50 copies/mL) with no emergent drug resistance |
Helsinn Group, of Lugano, Switzerland |
Anamorelin |
Ghrelin receptor agonist |
Weight loss, anorexia |
First patient dosed in global program (2 24-week double-blind, randomized, placebo-controlled confirmatory trials) to evaluate efficacy and safety in patients with advanced non-small-cell lung cancer with cachexia; primary efficacy endpoint, measured at week 9, based on concomitant occurrence of clinically relevant improvement of body weight and 5-item Anorexia Symptoms Scale score in those alive at day 64 |
Viiv Healthcare Ltd., of London |
Cabotegravir and rilpivirine |
HIV-1 integrase strand transfer inhibitor and NNRTI |
HIV-1 |
48-week data from ATLAS and FLAIR studies showed both met primary endpoints of noninferiority in maintaining viral suppression in adults at every-4-week injections vs. oral, daily, 3-drug regimen |
Notes For more information about individual companies and/or products, see Cortellis. |