The phase III pivotal trial of mavacamten, an oral, allosteric cardiac myosin modulator for treating symptomatic, obstructive hypertrophic cardiomyopathy, from Myokardia Inc., of Brisbane, Calif., hit its primary and all of its secondary endpoints.
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
DUBLIN – Tolerogenixx GmbH is on track to move its cell-based immune tolerance induction therapy for kidney transplant recipients into a 200-patient phase IIb trial, following the publication of promising data from a phase Ib trial, in 10 patients, in which all participants had a successful transplant at one-year follow-up.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Pharma, Infinity, Kiniksa, Lilly, Merck, Myokardia, Oyster Point, Protalix, Strongbridge, Tolerogenixx.
While COVID-19 dominated the clinical data news during the month of April, with 45% due to trial delays, suspensions and terminations, and another 12% focused on therapeutic and vaccine development targeting the deadly infection, a number of companies still posted positive phase III data for other indications and are preparing for regulatory filings and commercialization.
“All along our guidance has been that, look, we are doing multiple open-label studies with the intent of picking a winner,” said Protagonist Therapeutics Inc. CEO Dinesh Patel during a conference call with investors. “Today, we have picked a winner by a huge margin” in the shape of PTG-300, an injectable hepcidin mimetic for the rare blood cancer polycythemia vera (PV).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amgen, Cytodyn, Daewoong, Five Prime, Flexion, Kadmon, Lundbeck, Millendo, Protagonist, Revance, Savara, Scholar Rock.
Two companies, Hightide Therapeutics Inc. and Axcella Health Inc., posted positive data from recent liver disease studies while Enanta Pharmaceuticals Inc. missed its phase II liver study’s primary endpoint.
CEO Carsten Brunn said Selecta Biosciences Inc. has “not seen a material impact” from the COVID-19 pandemic and remains on track to report in the third quarter phase IIb data from a head-to-head trial comparing its refractory gout candidate, SEL-212, with Krystexxa (pegloticase), from Horizon Therapeutics plc, of Dublin.
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