Company Product Description Indication Status
Phase I
Galera Therapeutics LLC, of Malvern, Pa. GC-4419 Dismutase mimetic Locally advanced pancreatic cancer Median overall survival for the 42 patients in the study followed for at least 6 months was 20.1 months for GC-4419 plus radiation therapy and 10.9 months for radiation therapy alone; 29% of patients treated with GC-4419 plus radiation therapy achieved a partial response compared to 11% of patients treated with radiation therapy alone
Reven Holdings Inc., of Westminster, Colo. RJX  Mixture of antioxidant and anti-inflammatory ingredients High-risk COVID-19 First patient treated in the study, who had hypoxemia, pneumonia and elevated inflammation markers in the blood, responded to the therapy with normalized  inflammation markers and resolved the hypoxemia; patient was discharged home on day 5
Xencor Inc., of Monrovia, Calif. XmAb-564 IL-2-Fc cytokine  Autoimmune diseases First healthy volunteer treated in the study testing the safety and tolerability of single ascending doses of XmAb-564; the effect on immunomodulatory biomarkers will also be evaluated
Phase II
Adverum Biotechnologies Inc., of Redwood City, Calif. ADVM-022 Gene therapy expressing the VEGF inhibitor aflibercept Diabetic macular edema A patient in the Invinity study treated with the high dose (6 x 10^11 vg/eye) of ADVM-022 developed hypotony, with panuveitis and loss of vision in the treated eye; study, which had completed dosing, is being unmasked
Aerie Pharmaceuticals Inc., of Durham, N.C. AR-15512 TRPM8 agonist Dry eye disease Completed enrollment of the Comet-1 study; top-line data expected in the third quarter of 2021
Alphamab Oncology Co. Ltd., of Suzhou, China KN-046  PD-L1/CTLA4 bispecific antibody First-line non-small-cell lung cancer Plans to run a phase II study testing the efficacy, safety and tolerability of KN-046 plus Inlyta (axitinib), which will be supplied by Pfizer Inc.
Aptinyx Inc., of Evanston, Ill. NYX-783 NMDA receptor modulator Post-traumatic stress disorder More patients treated with the 50-mg dose achieved a Clinically Reliable Change (improvement of ≥13 points on the CAPS-5 Total score) compared to placebo (p<0.05); after adjustments for variances in patients’ time since trauma, the 50-mg dose improved CAPS-5 Total score compared to placebo (p<0.05)
Cara Therapeutics Inc., of Stamford, Conn. Korsuva (difelikefalin) Opioid receptor kappa agonist  Moderate to severe pruritus in mild to severe atopic dermatitis In the Kare study, Korsuva didn’t improve the weekly mean of the daily 24-hour Itch NRS score at week 12; 1-mg dose improved NRS score at week 1, which was sustained through 75% of the treatment period; in the mild to moderate (BSA<10%) patient population, NRS score improved for all doses vs. placebo (p=0.036)
Hutchison China Meditech Ltd., of Hong Kong HMPL-689 PI3K-delta inhibitor Relapsed or refractory follicular lymphoma and marginal zone lymphoma First patient treated in the study expected to enroll approximately 100 patients with FL and approximately 80 patients with MZL; primary endpoint is objective response rate; secondary endpoints include complete response rate, progression-free survival, time to response and duration of response 
Inflectis Bioscience SAS, of Nantes, France Guanabenz EIF2alpha-phosphatase inhibitor Amyotrophic lateral sclerosis Data published in Brain showed guanabenz plus riluzole produced significantly lower difference in the median rate of change of ALSFRS-R; drug produces hypotension that precludes further development; company is developing IFB-088, an analogue to guanabenz designed to eliminate hypotensive side effects
Innovent Biologics Inc., of San Francisco IBI-302 Recombinant human anti-VEGF and anti-complement bispecific fusion protein Ubfoveal or parafoveal choroidal neovascularization secondary to neovascular age-related macular degeneration First patient treated in the study measuring visual acuity and retinal thickness, as well as the effect on macular atrophy and fibrosis
Partner Therapeutics Inc., of Lexington, Mass. Leukine (sargramostim) Yeast-derived rhuGM-CSF Non-hospitalized COVID-19 patients Enrolled first patient in the Scope study; primary endpoint is the proportion of patients who experience COVID-19-related emergency room visit, COVID-19-related hospitalization or death
Quantum Leap Healthcare Collaborative, of San Francisco, Abbvie Inc., of North Chicago, and Takeda Pharmaceutical Co. Ltd., of Tokyo Cenicriviroc CCR2/5 inhibitor Critically ill COVID-19 Drug is not likely to reduce time to recover or mortality and is being dropped from the I-SPY platform study
Vifor Pharma Group, of St. Gallen, Switzerland, and Angion Biomedica Corp., of Uniondale, N.Y. ANG-3777  Hepatocyte growth factor mimic Cardiac surgery-associated acute kidney injury Completed enrollment in the ANG-3777 study; top-line data expected in the second half of 2021
Phase III
Akebia Therapeutics Inc., of Cambridge, Mass. Vadadustat HIF prolyl hydroxylase inhibitor Anemia The New England Journal of Medicine published separate articles on phase III Inno2vate program to treat anemia due to chronic kidney disease in adults on dialysis, which met noninferiority vs. darbepoetin alfa for cardiovascular safety and maintenance of hemoglobin concentrations, and Pro2tect study in adults not on dialysis, which met prespecified noninferiority for hematologic efficacy but not for cardiovascular safety
Atea Pharmaceuticals Inc., of Boston AT-527 RNA polymerase inhibitor COVID-19 First of about 1,400 non-hospitalized participants with mild to moderate infection dosed in Morningsky trial; primary efficacy endpoint is time to alleviation or improvement of COVID-19 symptoms vs. placebo
Brii Biosciences Ltd., of Beijing BRII-196 + BRII-198 COVID-19 Spike glycoprotein inhibitors COVID-19 NIH Activ-2 trial advanced to phase III following data safety monitoring board review of data from 220 participants in phase II portion; phase III part designed to assess whether drug combination prevents composite endpoint of hospitalization or death through day 28
Can-Fite Biopharma Ltd., of Petach Tikva, Israel Piclidenoson Adenosine A3 receptor agonist Psoriasis Comfort study assessing noninferiority vs. Otezla (apremilast, Amgen Inc.) achieved 75% enrollment; top-line data expected in fourth quarter of 2021
Eisai Inc., of Woodcliff Lake, N.J. Lenvima (lenvatinib) Multiple receptor tyrosine kinase inhibitor  Thyroid cancer European Journal of Cancer published post-hoc analysis of Select study assessing impact of lung metastases on overall survival in people with locally recurrent/metastatic, progressive radioiodine-refractory differentiated disease, originally presented at ESMO annual meeting in September 2019
Pharnext SA, of Paris PXT-3003 (baclofen + naltrexone hydrochloride + sorbitol) PMP22 gene inhibitor Charcot-Marie-Tooth disease type 1A Interim analysis of ongoing open-label Pleo-CMT-FU extension study showed sustained benefits, measured by Overall Neuropathy Limitation Scale, at 54 months of total trial time; improvement seen across all cohorts
Vascular Therapies LLC, of Cresskill, N.J. Sirogen Formulation of sirolimus for local, perivascular drug delivery End stage renal disease; chronic kidney disease Access study missed primary endpoint of fistula suitability for dialysis at 6 months; subgroup of those 65 and older showed improved overall and forearm fistula maturation and improved suitability for dialysis at 12 months
Zambon SpA, of Milan Liposomal cyclosporine A for inhalation Calcineurin inhibitor Bronchiolitis obliterans syndrome Poster described patient safety and data integrity adaptations during Boston program to address COVID-19 pandemic, including remote visits and inclusion of remote spirometry assessments with home portable spirometers

Notes

For more information about individual companies and/or products, see Cortellis.