Company

Product

Description

Indication

Status

Date

Phase I

Eisai Co. Ltd., of Tokyo, and Purdue Pharma LP, of Stamford, Conn.

Lemborexant

Small-molecule inhibitor of orexin signaling

Insomnia

Data published in SLEEP showed no statistically significant next-day impairment of driving performance in healthy adult and elderly volunteers vs. placebo the morning after bedtime administration, meeting the trial's endpoint

1/23/19

Phase II

TaiwanJ Pharmaceuticals Co. Ltd.

JKB-122

TLR-4 antagonist

Autoimmune hepatitis

20 participants with inadequate response to current treatment participated in 24-week open-label, escalating-dose study, receiving once-daily JKB-122 at 5 mg, potentially increased monthly up to 40 mg; at week 24, 31% were responders, defined as >50% decrease from baseline or decrease to normal ALT range; trial achieved primary efficacy endpoint with statistical significance (p<0.05) compared to baseline in the responder group, with mean ALT change of -70 IU (80.6%), p=0.004; secondary endpoints achieved with mean change of AST -32.8 IU (67.2%), p=0.022; mean GGT change of -77 IU (66.8%), p=0.033; mean ALP change of -17.8 IU (29.4%)

1/22/19

Twi Biotechnology Inc., of Taipei, Taiwan

AC-203

Topical formulation of 1% diacerein

Inherited epidermolysis bullosa

Completed patient enrollment in study testing AC-203 in EB, including epidermolysis bullosa simplex, dystrophic epidermolysis bullosa and junctional epidermolysis bullosa; top-line results expected in the second quarter of 2019

1/22/19

Phase III

Bio-Thera Solutions Ltd., of Guangzhou, China

BAT-1806

Tocilizumab biosimilar

Rheumatoid arthritis

Dosing begun to compare safety and efficacy to reference product Roactemra (tocilizumab, Roche Holding AG); results expected in the second half of 2020

1/22/19

Notes

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

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