Human Trials

MyoKardia begins dosing in phase 2 HCM trial of Mavacamten

MyoKardia has started dosing in its phase 2 MAVERICK-HCM clinical trial of mavacamten, the company’s oral, allosteric modulator of cardiac myosin mavacamten candidate in symptomatic non-obstructive hypertrophic cardiomyopathy patients.

Sellas’ NeuVax + Herceptin combination treatment shows significant effect in breast cancer trial

Sellas Life Sciences Group has reported a positive interim data from the prospective, randomized, single-blinded, controlled Phase 2b independent investigator-sponsored clinical trial (IST) of trastuzumab (Herceptin) +/- nelipepimut-S (NeuVax™) in HER2 1+/2+ breast cancer patients in the adjuvant setting to prevent recurrences.

Pfizer’s tafamidis meets primary endpoint in phase 3 transthyretin cardiomyopathy study

Pfizer sad its Tafamidis phase 3 transthyretin cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating a statistically significant reduction in the combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo at 30 months

Protagonist Therapeutics stops ulcerative colitis trial of PTG-100

Protagonist Therapeutics said it is discontinuing the Phase 2b PROPEL study of PTG-100, its investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis (UC).

Ablynx’s vobarilizumab fails to meet primary endpoint in phase II lupus study

Ablynx’s lupus erythematosus treatment vobarilizumab has failed to meet primary endpoint in the phase II dose-ranging study.

Mitsubishi Tanabe, Hitachi to use AI for improving efficiency of clinical trials

Mitsubishi Tanabe Pharma has partnered with Hitachi to improve the efficiency of clinical trials for the development of new drugs through the latter's artificial intelligence (AI) technology.

Roche’s lung cancer combination drug shows significant survival benefit

Roche has announced that its Tecentriq (atezolizumab) combined with Avastin (bevacizumab) plus carboplatin and paclitaxel (chemotherapy) showed a clinically significant survival benefit in a phase III lung cancer study.

GSK begins phase III trial of Benlysta, rituximab combo in systemic lupus erythematosus

GSK has commenced a phase III trial to evaluate Benlysta (belimumab) in combination with rituximab in adult patients with systemic lupus erythematosus (SLE).

Arena’s etrasimod meets primary and secondary endpoints in ulcerative colitis trial

Arena Pharmaceuticals has reported positive topline phase 2 results from the OASIS trial for etrasimod, an investigational, once-daily, orally administered, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of ulcerative colitis (UC).