Laxxon Medical Announces Successful Product Development Milestone with Novel Oral Modified-Release Formulation of Veru's Enobosarm, Utilizing Laxxon's SPID ® -Technology
'This milestone underscores the strength of our SPID®-Technology in enhancing bioavailability and optimizing drug release profiles,' said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical.
The novel tablet formulation achieved the desired target release profile, including a reduced maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak plasma concentration, and a similar extent of absorption (AUC) compared to historical values for immediate release enobosarm capsules.
'This milestone underscores the strength of our SPID ® -Technology in enhancing bioavailability and optimizing drug release profiles,' said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical. 'The collaboration with Veru reflects our commitment to advancing next-generation drug formulations, and we are excited to support them on their product development pathway.'
Sequential release of APIs, processing of molecules like peptides in combination with permeation enhancers, processing of nanoparticles, multi-compartment tablets starting at a micro-tablet dimension as small as < 750 micron, are just some of the various possibilities which SPID ® -Technology enables, and multiple other functionalities can be combined in one tablet with the potential upscaling from lab to mass production.
'Selecting Laxxon as our formulation development partner was a strategic decision, driven by the strength of their SPID ® platform and their proven expertise in advanced drug formulation,' said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. 'The resulting modified-release oral formulation of enobosarm has multiple benefits when treating the intended patient population and represents a significant advance over conventional drug product dosage forms as we move towards Phase 3 clinical trials and potential commercialization, pending regulatory approval.'
About Laxxon Medical
Laxxon Medical Corp. is a leading pharma-technology company and global leader of smart drug delivery systems in the pharmaceutical industry, pioneering a new generation of advanced pharmaceuticals designed to optimize drug delivery and maximize patient success through SPID ® -Technology, Laxxon's proprietary screen printing technology platform.
SPID ® -Technology unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities in drug development and commercialization.
With SPID ® -Technology, Laxxon can develop and manufacture advanced versions of new and existing pharmaceutical drugs while extending and adding new patent protection through the technology transfer process. Laxxon can fully utilize the FDA's 505b(2) regulatory pathway in the US and Hybrid applications under article 10(3) of Directive 2001/83/EC in the EU, which fast tracks product routes to market.
Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 13 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing, and together with the licensed IP from Exentis Group, consists of >230 patents and patent applications with more than 5,000 patent claims.
About Veru Inc.
Veru Inc. is a late clinical-stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass, thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. For more information, visit www.verupharma.com
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