Laxxon Medical Corp.

Aug. 11, 2025 -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced selection of a novel modified release oral formulation for enobosarm, a selective androgen receptor modulator, for chronic weight loss management, following confirmation of pharmacokinetic endpoints in a clinical study. The single dose, open label pilot study evaluated the plasma concentration versus time profile of a proprietary, patentable modified release formulation of enobosarm 3mg. The new formulation demonstrated the intended distinct target product release profile, which includes a reduction in maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak plasma concentration, and similar extent of absorption (AUC) compared to historical values for enobosarm immediate release capsules. “The novel enobosarm oral formulation’s unique manufacturing process is protected by a robust patent estate of already issued global patents with protection through 2037 and beyond. Patent applications on enobosarm’s new oral formulation have been filed and if issued, expiry is expected to be 2046,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “This novel modified release oral enobosarm formulation is planned to be available for the Phase 3 clinical studies and for commercialization.” The novel modified release oral formulation of enobosarm was developed in collaboration with Laxxon Medical using smart delivery systems, including the Company’s proprietary patented SPID®-Technology to create advanced, unique oral delivery release profiles, as well as an innovative additive manufacturing process. “We are proud to partner with Veru, which leveraged our proprietary SPID®-Technology to develop a novel oral formulation while ensuring strong IP protection for future commercialization,” said Helmut Kerschbaumer, Chief Executive Officer of Laxxon Medical. “This innovation has the potential to meaningfully advance Veru’s clinical program and differentiate its enobosarm formulation.” Veru 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. Obesity Program - Enobosarm is a next generation drug that makes weight reduction by GLP-1 RA more tissue selective for fat loss – Phase 2b QUALITY clinical studyEnobosarm Obesity Program The Company has previously announced positive topline and safety results from the Phase 2b QUALITY clinical study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (≥60 years of age) receiving semaglutide (Wegovy®) for chronic weight management. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy in a double-blind fashion for 12 weeks. On June 24, 2025, the Company announced positive results from the Phase 2b QUALITY and Maintenance Extension clinical study showing enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation. In conclusion, the Phase 2b QUALITY and Maintenance Extension clinical trial confirms that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of both weight and fat mass during the maintenance period such that by end of study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group. Laxxon Medical 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 3D screen printing (3DSP) 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 more than 230 patents and patent applications with more than 5,000 patent claims. The content above comes from the network. if any infringement, please contact us to modify.

Using their SPID®-Technology, Laxxon Medical has manufactured a 3D printed oral tablet combining a GLP-1 receptor agonist and a permeation enhancer intended to increase bioavailability LXM.2 is being developed using the 505(b)2 pathway with an expected NDA submission in early 2027 Laxxon is seeking to partner or out-license LXM.2 NEW YORK, NY / ACCESSWIRE / May 22, 2024 / Laxxon Medical announced today the development program for LXM.2, a 3D printed oral glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of adults and pediatric patients 12 years and older with obesity. LXM.2 is an enterically coated oral solid tablet consisting of a GLP-1 receptor agonist combined with a permeation enhancer intended to increase bioavailability. The addition of the permeation enhancer was made possible using Laxxon Medical's SPID® (Screen Printed Innovative Drug) platform technology. "Polypeptides and proteins like GLP-1s are known to have low bioavailability due to the degradation in the GI tract and poor uptake, meaning they need protection from degradation and their absorption benefits from permeation enhancers. Traditionally, it has been difficult to manufacture products containing the permeation enhancer via conventional methods, such as direct compression or granulation, given its physicochemical properties. It has additionally been challenging for these traditional manufacturing methods to apply an enteric coating to the finished product." said Dr. Achim Schneeberger, Laxxon Medical's Chief Scientific Officer. "SPID®-Technology is not only characterized by precise and tailored dosing - its unique formulation allows manufacturing of oral solids containing clinically relevant doses of permeation enhancers at convincing hardness and low friability." The active pharmaceutical ingredient (API) in LXM.2 has already been approved by the FDA for use in adults and pediatric patients 12 years and older with obesity. LXM.2 is eligible to be developed using the 505(b)2 pathway. Laxxon has designed a streamlined development program and is targeting an NDA submission in early 2027. Laxxon Medical CEO Helmut Kerschbaumer said: "LXM.2 would be a game-changer for patients struggling with obesity. Injectable medications, while effective, can be inconvenient and pose a barrier for some people. An oral option would offer greater ease of use and potentially improve adherence to treatment. This could significantly increase the number of patients who can successfully manage their weight and achieve long-term health benefits. The ability to use the 505(b)2 pathway means we can potentially get LXM.2 to patients quickly." Laxxon is seeking to partner or out-license LXM.2. A team of Laxxon Medical representatives will be attending BIO in San Diego, June 3-8, 2024. Read more about LXM.2 here. About Laxxon Medical Laxxon Medical is a pharma-technology company pioneering a new generation of advanced pharmaceuticals with SPID®, a novel 3D screen printing platform technology. For new and common pharmaceutical drugs, SPID® unlocks innovative drug delivery advancements paired with fast-tracked market access and extensive IP protection to yield disruptive opportunities for partners and life-changing results for patients. 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 consists of 150 patents and patent applications with more than 3,000 patent claims. Investor Contact: Alexander Ruckdaeschel, Chief Strategy Directoralexander.ruckdaeschel@laxxonmedical.com Business Development Contact: Jessica McHargue, Director of Business Development jessica.mchargue@laxxonmedical.com Media Contact: Frances Hoggard, Communications Manager frances.hoggard@laxxonmedical.com SOURCE: Laxxon Medical View the original press release on accesswire.com