Phase I

Trevena Inc., of Chesterbrook, Pa.



Healthy volunteers

Completed enrollment in the QT study; top-line data expected in 4Q19

Phase II

Daiichi Sankyo Europe GmbH, of Munich

Bempedoic acid

ATP citrate lyase inhibitor

Hypercholesterolemia with type 2 diabetes

Bempedoic acid plus ezetimibe lowered low-density lipoprotein cholesterol (LDL-C) by 40% compared to ezetimibe alone; 39% of patients achieved LDL-C <70 mg/dl; 41% of patients had at least a 50% reduction in LDL-C; high-sensitivity C-reactive protein was reduced by 25% (p<0.001) compared to ezetimibe alone; no differences in hemoglobin A1c

Immunicum AB, of Gothenburg, Sweden


Activated allogeneic dendritic cells

Newly diagnosed, intermediate and poor-prognosis metastatic renal cancer

In the Mereca study, ilixadencel plus Sutent (sunitinib, Pfizer Inc.) produced complete tumor responses in 5 out of 45 patients (11%) compared to 1 out of 25 patients (4%) for Sutent monotherapy; median overall survival hasn't been reached for either arm; 18-month survival was 63% for in the ilixadencel plus Sutent arm and 66% for Sutent alone

Phase III

Abbvie Inc., of North Chicago

Rovalpituzumab tesirine (Rova-T)

Antibody-drug conjugate targeting delta-like protein 3

Advanced small-cell lung cancer

During a pre-planned interim analysis of the Meru study, Rova-T produced no survival benefit compared to placebo; study closed on recommendation of the independent data monitoring committee; Rova-T research and development program has been terminated

Astrazeneca plc, of Cambridge, U.K.


Monoclonal antibody targeting subunit 1 of the type I interferon receptor

Systemic lupus erythematosus

The 373-patient Tulip 2 study met its primary endpoint with anifrolumab reducing disease activity compared to placebo, as measured by the British Isles Lupus Assessment Group-based Composite Lupus Assessment at week 52; data to be presented at a forthcoming medical meeting

Mitsubishi Tanabe Pharma America Inc., Jersey City, N.J.


Continuous subcutaneous carbidopa/levodopa

Parkinson's disease

Started the Boundless study of approximately 300 patients testing the efficacy, safety and tolerability of ND-0612 compared to immediate-release carbidopa/levodopa; primary endpoint is daily "good on time," defined as the sum of on time without dyskinesia and on time with non-troublesome dyskinesia

Opko Healthy Inc., of Miami

Somatrogon (hGH-CTP)

Human growth hormone with a carboxyl terminal peptide

Growth hormone deficiency

Last patient completed the final visit in the 224-patient study comparing once-weekly somatrogon to once-daily Genotropin (somatropin, Pfizer Inc.) with a primary endpoint of height velocity at 52 weeks; top-line data expected in the 4Q19

Venatorx Pharmaceuticals Inc., of Malvern, Pa.


Beta-lactamase inhibitor

Complicated urinary tract infections

Started enrollment in the 582-patient study testing the efficacy, safety and tolerability of VNRX-5133 plus cefepime compared to meropenem using clinical cure and microbiological eradication as the primary composite efficacy endpoint; top-line data expected by the end of 2020


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


No Comments