Announced Research Updates
The bio-pharmaceutical company Orphazyme A/S has reportedly announced that it has finished enrollment in its phase 3 study assessing arimoclomol for the treatment of Amyotrophic Lateral Sclerosis (ALS) before schedule. The full analysis remains on track for the first half of 2021.
J&J is testing their 6-dose, multi-antigen HIV vaccine in 2,600 sexually active women aged between 18 and 35 years in Southern Africa in the Phase IIb Imbokodo trial (results expected in 2021) and in the Phase III Mosaico trial, involving 3,800 men who have sex with men and transgender people aged between 18 and 60 years in the U.S., South America and Europe. The two trials use vaccines composed of different antigens to reflect the predominant strains in the region.
Vanda announced that in the 126 patient, Phase II, Motion Sifnos trial, treatment with tradipitant decreased the percentage of participants vomiting (17.5% vs 39.7%) but did not improve the mean Motion Sickness Severity Scale (MSSS) worst score among participants on one of seven sailing voyages on the Pacific. Both a reduction in emesis and the MSSS was seen in rough seas, but no significant improvement was seen in calm conditions.
Published Research Updates
In a 52-week, 342 patient, Phase III, open-label trial, treatment with trifarotene cream achieved an IGA of clear/almost clear and ≥2 grade improvement in 65.1% of patients and a physician's global assessment in 66.9% of patients with moderate facial acne and moderate truncal acne.
In a 59 patient, Phase II trial, levosimendan did not improve sitting slow vital capacity in patients with amyotrophic lateral sclerosis (ALS).
In the 65-patient, Phase II trial, neither tremelimumab plus durvalumab nor durvalumab monotherapy appreciably improved the objective response rate (3% vs 0%) in patients with metastatic pancreatic ductal adenocarcinoma.
In a 32 patient, Phase III trial, levosimendan compared to dobutamine had similar increases in renal blood flow (22% and 26%, respectively), better glomerular filtration rate, and filtration fraction was not affected by levosimendan but decreased by 17% with dobutamine in patients with heart failure and renal impairment. In a 72-patient trial, levosimendan did not reduce the occurrence rate of acute kidney injury compared to milrinone in infants after open-heart surgery with cardiopulmonary bypass.
Glaxo’s Zejula Meets Main Goal in Late-Stage Study: Glaxo’s GSK phase III PRIMA study, evaluating Zejula (niraparib) for patients with ovarian cancer in first-line maintenance setting, met the primary endpoint. Data from the study showed that treatment with its PARP inhibitor, Zejula,` led to a statistically significant improvement in progression-free survival in women regardless of their biomarker status, thereby meeting the study’s primary endpoint. Zejula was added to Glaxo’s portfolio following the acquisition of Tesaro earlier this year.
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