17:53 , Jul 20, 2018 |  BC Week In Review  |  Clinical News

Spyryx's SPX-101 improves lung function in Phase II CF trial

Spyryx Biosciences Inc. (Durham, N.C.) said high-dose SPX-101 given via a portable nebulizer led to a placebo-adjusted increase in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline to day 28 of 5.2%...
13:01 , May 25, 2018 |  BioCentury  |  Product Development

Patients at the core

With excitement mounting for the seven hemophilia gene therapies in the clinic, the National Hemophilia Foundation wanted to avoid a scenario in which patients, physicians and payers had no good way to compare them. The foundation...
23:58 , Apr 19, 2018 |  BC Innovations  |  Product R&D

Automation navigation

Last year’s approvals of the first two CAR T therapies have prompted the field to get serious about industrializing manufacturing of the cells to improve reproducibility and lower costs. While stakeholders agree that automation will...
21:40 , Dec 1, 2017 |  BC Week In Review  |  Clinical News

Spyryx starts Phase II for CF

Spyryx Biosciences Inc. (Durham, N.C.) began a Phase II trial evaluating SPX-101 in up to 78 patients with cystic fibrosis. The placebo-controlled, Canadian and European trial will evaluate 2 dose levels of twice-daily inhaled SPX-101 for...
00:31 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

Abide begins Phase Ib trial for neuroinflammatory pain candidate ABX-1431

Abide Therapeutics Inc. (San Diego, Calif.) began a crossover Phase Ib trial of ABX-1431 to treat neuroinflammatory disorders associated with central pain. ABX-1431 is a small molecule inhibitor of monoglyceride lipase (MGLL; MAGL), which...
21:27 , Sep 29, 2017 |  BC Week In Review  |  Clinical News

Aptinyx starts Phase II trial of NYX-2925 to treat neuropathic pain

Aptinyx Inc. (Evanston, Ill.) began a Phase II trial of NYX-2925 to treat neuropathic pain associated with diabetic peripheral neuropathy. The double-blind, placebo-controlled, U.S. trial will evaluate multiple dose levels of once-daily NYX-2925 for 4...
20:06 , Jul 7, 2017 |  BC Week In Review  |  Clinical News

Innate's MIS416 fails in Phase IIb for MS

Innate Immunotherapeutics Ltd. (ASX:IIL) reported top-line data from a double-blind, Australian and New Zealand Phase IIb trial in 93 patients with secondary progressive multiple sclerosis (MS) showing that once-weekly 500 μg IV MIS416 for 52...
21:27 , Jun 16, 2017 |  BC Week In Review  |  Clinical News

Alkermes begins Phase IIIb of ALK 5461 in MDD

Alkermes plc (NASDAQ:ALKS) began the double-blind, placebo-controlled, international Phase IIIb Study 217 to evaluate once-daily oral ALKS 5461 for 11 weeks as adjunctive treatment in about 325 patients with major depressive disorder (MDD). The trial’s primary...
03:09 , Jun 9, 2017 |  BC Week In Review  |  Clinical News

Lilly reports detailed MONARCH 2 data of abemaciclib in breast cancer

Eli Lilly and Co. (NYSE:LLY) reported additional data from Phase III MONARCH 2 trial in 669 postmenopausal women with hormone receptor-positive, HER2-negative breast cancer showing that twice-daily 150 mg oral abemaciclib (LY2835219) plus Faslodex fulvestrant...
01:40 , May 5, 2017 |  BC Week In Review  |  Clinical News

Spyryx reports positive Ph I safety data for SPX-101

In February, Spyryx Biosciences Inc. (Durham, N.C.) reported that single and multiple ascending doses of inhaled SPX-101 for 14 days were well tolerated and led to no dose-limiting toxicities (DLTs) in a Phase I trial...