BioSpace Global Roundup, March 12

Globe in Grass

Tiziana – London-based Tiziana Life Sciences announced its TZLS-501 treatment could be a potential treatment for patients infected with coronavirus (COVID-19) who are at risk of respiratory failure. Tiziana has teamed up with Switzerland-based Novimmune, SA to expedite the development of TZLS-501. Tiziana plans to administer TZLS-501 using a proprietary formulation technology. Tests have already shown that the treatment rapidly depletes circulating levels of IL-6 in the blood, the company said. Excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness.

LSP -- Holland-based LSP, a life sciences investor, closed its largest fund, LSP 6, with $600 million. This is the largest fund ever raised in Europe focused on life sciences ventures, the organization said. LSP currently has $1.1 billion of capital to invest across LSP 6, the LSP Health Economics Fund and LSP’s public fund and mandates. LSP 6 will, like its predecessor funds, invest in 15-18, predominantly European private companies developing new medications or medical technologies, who turn cutting-edge scientific innovations into real-world healthcare solutions.

Follicum – Sweden-based Follicum treated its first group of patients in a Phase II trial for hair growth. The patients were treated with FOL-005 cream. They will be treated daily for about four months to stimulate hair growth. In two previous clinical studies, FOL-005 has been shown to be an effective and safe treatment for hair growth stimulation. The upcoming phase II study aims to investigate the safety, efficacy and response of the drug candidate FOL-005 when administered as a topical formulation. The patients themselves will apply one of three different strengths of FOL-005 or placebo to the scalp, once daily in the evening. The study is expected to be completed and the results communicated around year-end 2020.

Kinepict Health – Hungary-based Kinepict Health Ltd. received 501(k) clearance from the U.S. Food and Drug Administration for its Kinepict Medical Imaging Tool (KMIT) software, which uses the company’s proprietary, ground-breaking Digital Variance Angiography (DVA). The proprietary DVA algorithm uses advanced statistical methods to visualize blood vessels by identifying contrast-induced changes in the X-ray angiography image series. First clinical validations show that DVA provides superior image quality compared to the state-of-the-art Digital Subtraction Angiography (DSA), the company said. It believes DVA technology will revolutionize the calculation of X-ray angiography images and innovate a “field in which the fundamental principles of data analysis were unchanged in the past four decades.” The FDA clearance paves the way for a timely start of the launch of the technology into the U.S. market. The company said it is open for talks with potential partners from the imaging industry or other health service organizations active in the angiography field.

Gedea Biotech – Women’s health company Gedea Biotech, based in Sweden, reported that 82% of women treated with its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis, were clinically cured after seven days. The cure rate corresponds to existing antibiotic-based treatment, the company said. The vaginal tablet, pHyph acts by restoring the patient’s pH to its normal level, it also breaks down the biofilm formed during bacterial vaginosis in which the infectious bacteria begin to thrive. Bacterial vaginosis (BV) is the most common vaginal infection with a prevalence of 10–29% in the whole female population and rising up to 50% in pregnant women. The symptoms of BV include vaginal discharge, a fishy odor and sometimes a burning pain. It can affect and limit many aspects of daily life. While the results are promising, Gedea cautions that further studies are needed to confirm results. Larger studies including recurrence data are being planned. The complete results from the trial will be presented at the European Spontaneous Preterm Birth Congress in May in the Netherlands.

Capitainer – A medtech startup based in Sweden, Capitainer raise SEK15 million (about $1.58 million) to support commercialization of its dried blood spot sampling solution, Capitainer qDBS. The Capitainer qDBS solution is designed to enable convenient and quantitative blood sampling at the fingertip. The patented solution ensures an exact sample volume of blood to be collected. Patients simply place a blood drop on the qDBS card which automatically fills a microchannel with the required amount and discards any excess. The potential for human error is thus completely eliminated. Subsequently, the blood volume contained in the microchannel automatically transfers to a pre-punched DBS paper, forming an accurate and high-quality dried blood spot sample, preserved for quantitative analysis.

Red Hill – Israel-based Red Hill Biopharma Ltd. initiated a Phase II evaluating opaganib, a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, in prostate cancer. The study is intended to evaluate the safety and efficacy of opaganib in patients with metastatic castration-resistant prostate cancer (mCRPC) that is progressing during treatment with androgen-signaling blockers abiraterone or enzalutamide. Based on pre-clinical data and literature indicating potential anti-viral activity, Red Hill is actively pursuing an exploratory program intended to evaluate the activity of opaganib and RHB-107, individually and in combination with hydroxychloroquine and other compounds in the treatment of COVID-19 (novel coronavirus).

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