BioSpace Global Roundup, May 7

Globe

Sigrid Therapeutics – Sweden’s Sigrid Therapeutics announced the publication of a scientific study in the peer-reviewed journal Advanced Healthcare Materials showing that a radical new approach using mesoporous silica particles (MSPs) can be used to prevent type 2-diabetes and treat obesity. By blocking food enzyme activity, MSPs reduce energy intake from food and lower blood sugar and other metabolic risk factors. The MSPs are administered orally in solution and passed harmlessly from the body in stools. The study report confirms previously reported reductions in glycated hemoglobin (HbA1c) and LDL cholesterol in man in response to MSP ingestion and also demonstrates sequestration of pancreatic amylase and lipase in a MSP pore-size dependent manner. Taken together, the results are compatible with a mode of action whereby a portion of the enzymes are trapped inside the MSPs resulting in an enzyme-blocking effect, the company said.

Affibody AB – South Korean-based Daewoong and Sweden’s Affibody strengthened their collaboration. Daewoong exercises its option under a collaboration agreement to develop and commercialize an innovative new half-life extended biotherapeutics product currently in preclinical development for the treatment of diabetes. Affibody will receive a license conversion fee and milestone payments as well as royalties. Financial details were not disclosed.

Combioxin SA – Switzerland’s Combioxin SA received a favorable review from the U.S. Food and Drug Administration for its pre-Investigational New Drug Application for CAL02 in COVID-19 patients. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program’s expedited process. The company will assess CAL02 versus placebo in its ability to prevent and treat secondary bacterial infection complications in COVID-19 patients. Based on guidelines for the management of viral pneumonia with respiratory failure, critically ill COVID-19 patients receive early administration of empirical antibiotics to prevent and treat suspected or confirmed secondary bacterial pneumonia, which inevitably amplifies the risk of increased resistance to commonly-used antibiotics, the company said.

Stilla Technologies – Stilla Technologies, a French provider of pioneering solutions for high-precision genetic analyses, announced its digital PCR solution, the Naica system, which can reliably detect the SARS-CoV-2 virus and measure its viral load, is now readily available to all research centers and hospitals involved in the fight against COVID- 19. Currently, SARS-CoV-2 infections are being diagnosed through a method called real-time reverse transcription polymerase chain reaction (RT-PCR). However, this technique fails to reliably detect low viral loads, which can occur when patients are mildly infected or in case of defective sampling. The difficulty to properly detect the virus with RT-PCR in these instances would partially explain why some Covid-19 patients test negative for SARS-CoV-2. Stilla's solution based on digital PCR (dPCR), a more accurate and sensitive method than RT-PCR, would make it possible to cut down on these false negative results, which currently hamper efforts to contain the re-emergence of the disease.

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RedHill Biopharma – Israel-based RedHill published results from a Phase III study of Talicia (RHB-105) for Helicobacter pylori (H. pylori) infection in the Annals of Internal Medicine. Talicia was approved by the FDA in November 2019. It is the only rifabutin-containing therapy approved for the treatment of H. pylori infection and is designed to address the high and growing resistance of H. pylori to the currently widely used clarithromycin-containing regimens. The trial compared Talicia against an equivalent dose dual therapy of amoxicillin and omeprazole in 455 treatment-naïve subjects with confirmed dyspepsia and H. pylori infection. Results demonstrated the added rifabutin benefit with 83.8% eradication of H. pylori infection with Talicia showed a 26.1% benefit with Talicia.

Pivotal – Pivotal, a full-service contract research organization based in Madrid, Spain, has been contracted to provide specialized clinical research services in a clinical trial to study the efficacy and safety of hyperimmune plasma, obtained from cured and convalescent COVID-19 patients, in the treatment of hospitalized patients with COVID-19 who are admitted in an acute phase. The historical aggregated data to date for COVID-19 and other diseases caused by coronavirus suggest that hyperimmune plasma´s transfusion to hospitalized patients with COVID-19 is safe, and that, due to the severity and high mortality of this disease and the potential advantages of hyperimmune plasma transfusion use, a clinical trial in the initial phase of this disease in these patients outweighs its potential risks, the company said.

LifeSignals – LifeSignals won CE Mark for its ECG Remote Monitoring Patch - a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate monitoring in ambulatory, hospital, healthcare and home settings. Healthcare professionals can remotely access this data and rapidly make treatment decisions independent of patient location.

Mesoblast Limited – Australia’s Mesoblast dosed the first patients in a Phase II/III trial for its allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support. Mesoblast holds an Investigational New Drug (IND) application cleared by the FDA for use of remestemcel-L in the treatment of patients with COVID-19 ARDS. The clinical protocol for the trial is based on initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at The Mount Sinai Hospital in New York.

NuCana – Scotland’s NuCana re-began to enrol new patients in NuTide:121, its ongoing global Phase III study of Acelarin (NUC-1031) plus cisplatin in patients with biliary tract cancer. The re-opening of NuTide:121 has begun in certain geographies, including Australia, Canada, South Korea, Taiwan, Ukraine, and the United Kingdom.  NuCana will work closely with the clinicians involved in NuTide:121 to re-open all of the clinical sites to new patient enrollment as soon as possible due to the ongoing COVID-19 pandemic.

NETRIS Pharma – Privately-held Netris Pharma SAS, based in France, entered into a clinical collaboration agreement with MSD to investigate the safety, clinical and biological activity of NP137 combined with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with locally advanced/metastatic uterine tumors. NP137 targets netrin-1, which is overexpressed in over two-thirds of uterine tumors. The companies entered into the collaboration based on clinical data obtained from a Phase I trial investigating NP137 monotherapy in patients with advanced solid tumors and the growing evidence that resistance to an anti-PD-1 therapy, such as Keytruda, can be alleviated when combined with blocking netrin-1.

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