Omnix Medical Starts Phase I Clinical Trial of Novel Anti-Infective; First Healthy Volunteers Dosed
– New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the initiation of a Dutch Phase I clinical trial with its lead compound OMN6. Since March 28, 2022, six healthy volunteers have been administered the novel antimicrobial, which is based on a naturally occuring mechanism of action (MoA) leading to a targeted, effective destruction of the cell membrane of pathogens. The trial is being conducted in Groningen, The Netherlands. OMN6 is being evaluated in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics of single and repeat IV infusion of the compound in healthy subjects. Results are expected by Q4, 2022.
Omnix Medical Advances Novel Anti-Infective Program into Clinical Development
– Entirely novel therapeutic principle to combat alarming worldwide rise of antimicrobial resistance (AMR)
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced it received approval by Dutch authorities to initiate a Phase I clinical trial with its lead compound OMN6 in healthy volunteers. The trial will be conducted in Groningen, The Netherlands.
OMN6, the lead compound of Omnix, is a first-in-class antimicrobial peptide for the treatment of life-threatening infections caused by Gram-negative bacteria. Read more…
Food for Thought: Weekly Wrap-Up
Hildegard Kaulen in Frankfurter Allgemeine Zeitung (FAZ) reports from the 61st Lindau Meeting of Nobel Laureates on the need for novel antibiotics. She features the talk of Thomas A. Steitz from Yale University on ribosomes and novel antibiotics. Steitz in 2009 received the chemistry nobel prize for the structure determination of ribosomes together with Ada Yonath and Venkatraman Ramakrishnan. This discovery has led to novel insights on antibiotics binding to these cellular organelles – an important prerequisite for the design of novel antibiotics as bacterial ribosomes still are the most important targets for antibiotics. Among others, the scientists learned that the larger the contact area of ribosomes and an antibiotic, the more mutations are necessary to evade the binding and anti-microbial activity of the compound. Steitz therefore recommends linking antibiotics. He also co-founded a company, Rib-X Pharmaceuticals, which is designing novel antibiotics by structure-based design. Its most advanced compound successfully completed a Phase II study this year.
Richard Friebe, also in FAZ, reports on a breakthrough in synthetic biology accomplished by a team of German, French and Dutch scientists and published in Angewandte Chemie. Other than Craig Venter, who rebuilt an organism by chemically synthesizing its DNA, the group designed a partially artificial organism. Using automated selection, the researchers transformed an E. coli strain unable to synthesize thymine nucleotides into an organism incorporating the artificial thymine analogue 5-chlorouracil instead of thymine into its entire DNA. The goal of the project was to demonstrate that it is possible to develop a generic technology for evolving the chemical constitution of microbial populations by using the simplest possible algorithms. Members of the team recently co-founded Heurisko USA Inc.
Die Welt reports on novel insights into the medical role of Helicobacter pylori, a bacterium living in the human stomach and known for its ability to cause gastritis, gastric ulcer and stomach cancer. Christian Taube from the University of Mainz and colleagues from Zurich University recently published findings that early infections with Helicobacter can protect against allergic asthma. In newborn mice, an early infection impaired maturation of dendritic cells in the lung and increased enrichment of regulatory T cells responsible for oppressing asthma. Resistance is lost once Helicobacter is eradicated with antibiotics. The researchers therefore think that the increase of allergic asthma may be caused by today’s widespread use of antibiotics.
Type 2 diabetes can be cured by a strict diet, reports Christina Berndt in Süddeutsche Zeitung (SZ). In a UK study comprising 11 type 2 diabetics, in 7 of the patients insulin production normalized and the liver started to respond to the hormone properly after they were put on a strict 600 kcal diet for 8 weeks. The cure even worked in patients suffering from diabetes for 4 years and the effects were lasting, provided the patients did not overeat subsequently.
William Pentland in Forbes writes that the US Defense Advanced Research Projects Agency (DARPA) is a driving force behind a new effort to harness biology as a manufacturing platform. The “Living Foundries” program is designed to fund projects that enable on-demand manufacturing capabilities for the production of advanced materials and devices. “Key to success,” DARPA writes, “will be the democratization of the biological design and manufacturing process, breaking open the field to those outside the biological sciences.” As examples, DARPA mentions next-generation DNA synthesis and assembly technologies, modular genetic parts and systems, and cell-based fabrication systems.
In a Forbes interview conducted by Alex Howard, Charlie Quinn, director of data integration technology at the Benaroya Research Institute, talks about the necessity of new tools and strategies to cope with today’s data deluge. Quinn, who is dealing with genomics, maintains that it is not only about novel technologies but also about cultural changes to create greater value by sharing data and establishing open source and even open data projects, sharing data much earlier than it is done now. Thereby, novel ideas can be spread earlier. “What we’ve been doing is going around and trying to convince people that we understand they have to keep data private up to a certain point, but let’s try and release as much data as we can as early as we can.”
Food for Thought: Weekly Wrap-Up
Matthew Herper of Forbes this week takes up the issue whether a DNA sequencer can get FDA approval and quotes Jay Flatley, president and CEO of Illumina as saying the company is in talks with FDA to get regulatory clearance to use its technology for medical diagnostics. He also writes about the late Adriana Jenkins, who worked for Celgene and Third Rock Ventures, among others, and died of breast cancer earlier this month. Having been treated as one of the first patients with one of the first personalized drugs, Herceptin, which gave her a decade of life, she calls for a new law that would give drug companies extended monopolies for developing personalized medicines. Her own last article explaining her plea for supporting personalized medicine by a legislation similar to the Orphan Drug Act is featured in Forbes, too.
Also in Forbes, Robert Langreth explains why Novo Nordisk decided to abandon development of diabetes pills and to ramp up insulin production instead – a move highly successful so far.