Phase I

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


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


Innovent Biologics Inc., of Suzhou, China


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


Phase III

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


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


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


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


Formulation of thymosin beta 4

Dry eye syndrome

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


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)



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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