Company

Product

Description

Indication

Status

Date

Phase I

Affinivax Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo

ASP-3772

MAPS vaccine targeting Streptococcus pneumoniae

Pneumococcal disease prophylaxis

Dosed first of approximately 618 patients in the study measuring safety and immunological response to ascending doses

2/13/19

Innovent Biologics Inc., of Suzhou, China

IBI-101

Anti-OX40 monoclonal antibody

Advanced solid tumors that have failed standard treatments

Treated first of 80 patients in study testing the tolerance, safety and primary efficacy of the drug as a monotherapy in phase Ia and in combination with Tyvyt (sintilimab) in phase Ib

2/14/19

Phase III

H. Lundbeck A/S, of Valby, Denmark, and Otsuka Pharmaceutical Co. Ltd., of Tokyo

Brexpiprazole

Partial agonist of serotonin 5-HT1A and dopamine D2 receptors and antagonist of serotonin 5-HT2A receptor

Manic episodes associated with bipolar I disorder

In 2 studies, the drug didn't meet the primary endpoint of statistical separation from placebo on the Young Mania Rating Scale at week 3; placebo scores on the rating scale were higher than expected in both studies

2/14/19

Pfizer Inc., of New York, and Astellas Pharma Inc., of Tokyo

Xtandi (enzalutamide)

Androgen receptor inhibitor

Metastatic hormone-sensitive prostate cancer

In the 1,150-patient Arches study, drug plus androgen deprivation therapy (ADT) reduced the risk of radiographic progression or death by 61% versus ADT alone (HR=0.39, p<0.0001); median radiographic progression-free survival wasn't met for drug plus ADT compared to 19.4 months for ADT alone; drug plus ADT also improved PSA progression and reduced the risk of starting a new antineoplastic therapy compared to ADT alone

2/12/19

Regentree LLC, joint venture between Gtreebnt, of South Korea, and Regenerx Biopharmaceuticals Inc., of Rockville, Md.

RGN-259

Formulation of thymosin beta 4

Dry eye syndrome

Initiated Arise-3 study of 700 patients; data expected in the first half of 2020

2/12/19

Ultragenyx Pharmaceutical Inc., of Novato, Calif., and Kyowa Hakko Kirin Co. Ltd., of Tokyo

Crysvita (burosumab)

Anti-FGF23 monoclonal antibody

X-linked hypophos-phatemia

In a 61-patient open-label study, after 64 weeks of treatment with Crysvita, Rickets Global Impression of Change Global Score had an LS mean treatment difference of +1.02 compared to oral phosphate and active vitamin D (p<0.0001); mean serum phosphorus levels reached the lower limit of normal range in patients treated with Crysvita compared to a small increase for oral phosphate and active vitamin D (p<0.0001)

2/14/19


Notes

The date indicated refers to the BioWorld Clinical data table in which the news item can be found.

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

 

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