Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Sweden-based Pilloxa, a digital health company, launched its ASTORIA study to assess its digital patient-centric adherence solution in patients with cardiovascular disease.
The study has been funded by a grant from the European Union through its EUROSTARS program. It is also being supported by life sciences giant Bayer. The aim is to further validate Pilloxa’s full suite of medication support services, including their adherence app-enhanced with mobile communication and a digitally connected pillbox that can enable remote patient monitoring. This includes alerting the patient to take their medication as prescribed and relaying their adherence patterns for further analysis. The data gathered will enable further development of the solution to increase the quality and effectiveness of drug treatment in both the healthcare setting and during clinical trials. The primary endpoint of this study is adherence to rivaroxaban as measured by the Pilloxa adherence solution.
In total, the ASTORIA trial will recruit 200 patients. Results from the trial are estimated to be reported in 2022.
Elsewhere across the globe:
Relief Therapeutics – Switzerland-based Relief Therapeutics and Acer Therapeutics signed an option agreement that provides an exclusive right to negotiate a potential collaboration and license agreement for worldwide development and commercialization for ACER-001. Acer’s ACER-001 (sodium phenylbutyrate) powder is a proprietary formulation in development for the treatment of urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD). The partnership is a chance for Relief to build a pipeline beyond its COVID-19 asset, RLF-100, which is under development for treatment of respiratory conditions, primarily acute respiratory distress syndrome (ARDS) due to COVID-19 infection.
Microcaps AG – Also based in Switzerland, Microcaps AG closed a CHF5 million seed financing round co-led by Helvetica Capital and Zürcher Kantonalbank. The financing will be used to help the company grow and scale-up its operations. Microcaps has developed a proprietary method to manufacture microcapsules in identical sizes that are used in pharmaceuticals, nutrition, cosmetics and other branches of industry. This means they all have exactly the same effect, with dosage and delivery rate of the active ingredient completely controlled. For drugs, this will allow precision dosing that could result in fewer side effects. In addition, the microcapsules with a controlled size can be produced 1000 times faster than with currently available devices, according to the company.
BioMed X – Germany-based BioMed X forged a partnership with Janssen Pharmaceutical to discover novel transport mechanisms in the human intestinal tract which could be utilized for oral delivery of diverse therapeutic modalities.
Gesynta Pharma AB – Based in Sweden, Gesynta Pharma AB announced the first patients have been dosed in a Phase II study of its oral drug candidate GS-248 in patients with systemic sclerosis. This proof-of-concept study will investigate the safety of GS-248 and its efficacy on Raynaud’s phenomenon and peripheral blood flow in this patient group. Study results are expected towards the end of 2021 and will provide the basis for future clinical trials both in systemic sclerosis and potentially other chronic inflammatory diseases. Gesynta Pharma’s first-in-class drug candidate GS-248 provides a combination of anti-inflammatory and vasodilatory effects by potently and selectively inhibiting microsomal prostaglandin E synthase-1 (mPGES-1). Systemic sclerosis is a progressive, autoimmune disease that leads to serious damage to the microvasculature.
Mundipharma – Based in the U.K., Mundipharma and its partner Cidara Therapeutics, announced the European Commission adopted the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) recommendation to grant Orphan Drug Designation (ODD) to rezafungin, a novel, once-weekly echinocandin, for the treatment of invasive candidiasis (IC). IC is characterized as a severe, life-threatening systemic Candida infection of the bloodstream and/or deep/visceral tissues, known as candidaemia and deep-seated tissue candidiasis.
FRIT – Japan’s Fuzionaire Radioisotope Technologies K.K. has entered into a feasibility study agreement with Nihon Medi-Physics Co., Ltd. FRIT is a joint venture between radiopharmaceutical companies Fuzionaire Diagnostics, Inc. and Japan Medical Isotope Technology Development K.K. The company was formed to develop and commercialize Fuzionaire Dx’s radiopharmaceutical technologies in Japan. Under the agreement, NMP will evaluate the ability of Fuzionaire Dx’s technology to create a new class of positron emission tomography (PET) radiopharmaceuticals. Fuzionaire Dx’s fluorine-18 radiolabeling platform, powered by a breakthrough in fundamental chemistry out of Nobel Prize winner.
