Following two clinical trial disappointments, the newest being the phase III failure of ampreloxetine, Theravance Biopharma Inc. will restructure by laying off three-quarters of its staff and will stop developing all but two of its non-respiratory disease programs. The ampreloxetine study for treating symptomatic neurogenic orthostatic hypotension failed to meet its primary endpoint, the company announced Sept. 15. In late August, data from a phase IIb dose-finding study showed izencitinib, a gut-selective pan-JAK inhibitor for treating ulcerative colitis, failed to meet its primary endpoint.
Cala Health Inc. is moving quickly to establish leadership in treatment for essential tremor with its recent inclusion in the International Essential Tremor Foundation (IETF) guidelines as the only non-pharmacological, non-surgical treatment recommended and positive treatment results from a real-world study. “We’re very pleased with the validation from IETF and the research presented at MDS that demonstrates the impactful benefit of our therapy for those suffering from essential tremor,” said Kate Rosenbluth, founder and chief science officer of Cala Health.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge. Those who have received the third dose of Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, showed 2.5-fold higher neutralizing potency against the Delta variant, compared to COVID-19 convalescents and two-dose vaccinees.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
While privately held Calcimedica Inc. posted positive top-line results from a phase II study of its lead candidate in treating patients with severe COVID-19 pneumonia, Redhill Biopharma Inc. took a tumble as preliminary top-line data from a phase II/III study of opaganib in treating hospitalized COVID-19 patients showed the endpoints failed to achieve statistical significance.
A fourth child has died after developing liver complications on a trial of Astellas Pharma Inc.’s gene therapy for rare neuromuscular disease, after FDA advisers noted the problems on the ASPIRO study in a discussion on gene therapy safety. Last week, Astellas announced that it had stopped dosing on ASPIRO after a safety issue involving liver function emerged in the trial of the gene therapy AT-132, aimed at the life-threatening rare disease X-linked myotubular myopathy.
The NIH and CDC granted researchers at the Feinstein Institutes for Medical Research at Northwell Health $700,000 to investigate an in-the-ear stimulator as a treatment for post-traumatic stress disorder (PTSD) in first responders to the attack on the World Trade Center 20 years ago. The researchers will enroll 30 World Trade Center first responders with chronic PTSD in a sham-controlled trial to test the effectiveness of a device that uses transcutaneous auricular stimulation of the vagus nerve, which has shown promise in preclinical studies.
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