Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Denmark’s Saniona initiated a Phase IIb trial of its investigational combination therapy Tesomet in patients with Prader-Willi syndrome (PWS). The company anticipates data will be available from the study in the first half of 2023.
Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. The Phase IIb study is expected to enroll approximately 120 patients with genetically-confirmed PWS. The trial will initially enroll adults, but the company plans to expand the study to include adolescents with PWS. The primary objective of the study will be change in hyperphagia at week 16. Hyperphagia is the abnormally increased appetite associated with PWS. Secondary endpoints include change in body weight and change in clinician impression of overall clinical status.
Saniona previously assessed Tesomet in a Phase II trial in adults and adolescents with PWS. Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.
“Currently, there are no approved treatments for hyperphagia, the uncontrollable hunger that is one of the most debilitating symptoms of PWS,” said Paige Rivard, chief executive officer of Prader-Willi Syndrome Association USA. “We are encouraged to see Saniona addressing hyperphagia, and we look forward to working with them to support this clinical trial through education and outreach amongst our community.”
Tesomet has been granted Orphan Drug designation in the U.S. The experimental drug is also being evaluated in a Phase IIb study for hypothalamus obesity.
Elsewhere around the globe:
Nykode Therapeutics – Norway-based Nykode Therapeutics AS dosed the first patient with its T cell focused next-generation SARS-CoV-2 vaccine candidate in its VB-D-01 Phase I/II trial. The vaccine is designed to prime T cells in order to potentially generate a broad immune response against current and future variants. VB10.2210 encodes a combination of conserved and immuno-dominant T cell epitope hotspots spanning multiple SARS-CoV-2 antigens.
Hansa Biopharma – Based in Sweden, Hansa Biopharma AB enrolled the first patient in its controlled pivotal trial, ConfIdeS, which is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. The trial is expected to randomize 64 highly sensitized kidney transplant patients. The primary endpoint for imlifidase is to evaluate benefit in transplanting highly sensitized patients is kidney graft function at 12 months.
Burning Rock Biotech – China-based Burning Rock announced its 2021 revenue to “be at or slightly above RMB500 million,” about $78.5 million.
Universe Pharmaceuticals Inc. – Also based in China, Universe Pharmaceuticals entered into a strategic collaboration with Jinggangshan University for a study on the chemical constituents of Liparis Odorata, a traditional Chinese medicine, for the treatment of hyperlipidemia.
