Laxxon Medical Achieves Major Product Development Milestone with Novel SPID®-Based Oral Modified-Release Formulation of Veru’s Enobosarm
Laxxon Medical Corp., a pioneering pharmaceutical technology company specializing in next-generation oral drug delivery systems, announced a significant advancement in its collaboration with Veru Inc. (NASDAQ: VERU), a late clinical-stage biopharmaceutical company focused on developing innovative therapies for cardiometabolic and inflammatory diseases. The companies revealed that Veru has selected a newly developed, modified-release oral formulation of enobosarm that leverages Laxxon’s proprietary SPID® (Screen Printing Innovation Drug) Technology—a novel platform designed to precisely engineer drug release profiles and improve therapeutic outcomes.
The newly developed formulation has successfully achieved its targeted pharmacokinetic goals, demonstrating the capability of SPID®-Technology to optimize the delivery of active pharmaceutical ingredients (APIs) in ways not possible with conventional tablet manufacturing methods. In testing, the modified-release enobosarm tablet achieved:
- Reduced Maximum Plasma Concentration (Cmax): By lowering Cmax compared to immediate-release formulations, the modified-release profile may help minimize peak-related side effects while maintaining therapeutic efficacy.
- Delayed Time to Maximum Plasma Concentration (Tmax): The formulation slows the rate of absorption, potentially extending the therapeutic window and improving patient convenience.
- Distinct Secondary Peak Plasma Concentration: The design enables controlled biphasic drug release, which may be advantageous for certain treatment regimens requiring sustained or multi-phase exposure.
- Comparable Area Under the Curve (AUC): Despite changes in the release pattern, the overall extent of absorption remains similar to historical immediate-release enobosarm capsules, suggesting maintained bioavailability.
These Laxxon characteristics are particularly important in drug development for chronic and complex conditions, where balancing efficacy, safety, and patient adherence is crucial.
SPID®-Technology: Redefining Oral Drug Delivery
Laxxon’s proprietary SPID®-Technology is a screen-printing-based manufacturing process that allows precise control over drug deposition within tablet structures. Unlike conventional manufacturing methods such as wet granulation or direct compression, SPID® enables the spatial and sequential placement of APIs and excipients in three-dimensional configurations. This capability opens the door to entirely new drug release strategies, including:
- Sequential Release of APIs: Multiple drugs or the same drug in different release forms can be incorporated into a single tablet for programmed delivery over time.
- Enhanced Peptide Delivery: The technology can process delicate molecules such as peptides in combination with permeation enhancers, improving absorption through the gastrointestinal tract.
- Nanoparticle Integration: APIs in nanoparticle form can be embedded to increase dissolution rates or target specific absorption sites.
- Multi-Compartment Tablets: Complex dosage forms with separate compartments—down to micro-tablet dimensions as small as <750 microns—can be manufactured with high precision.
- Functionality Combination: Controlled release, targeted release, and protective coatings can be integrated within the same tablet, enabling highly customizable pharmacokinetic profiles.
Perhaps most importantly, the SPID® Laxxon manufacturing process is designed for scalability. Formulations can be transitioned from laboratory-scale proof-of-concept batches to mass production without losing the fine structural and release characteristics established during development.
Strategic Collaboration Between Laxxon and Veru
The partnership between Laxxon Medical and Veru Inc. reflects a growing industry trend toward integrating advanced manufacturing technologies into Laxxon drug development early in the product lifecycle. By doing so, companies can design formulations that address known limitations of conventional dosage forms before pivotal Phase 3 trials and commercialization efforts begin.
“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.”
Dr. Mitchell Steiner, Chairman, President, and Chief Executive Officer of Veru, emphasized the strategic importance of the collaboration:
“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. 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 Enobosarm
Enobosarm is a Laxxon selective androgen receptor modulator (SARM) with a differentiated mechanism of action. It has been studied for a range of indications, with particular interest in conditions involving muscle wasting, frailty, and hormone receptor-positive cancers. More recently, Veru has been advancing enobosarm for potential use in cardiometabolic and inflammatory diseases.
The rationale for developing a modified-release formulation is rooted in optimizing its pharmacokinetic and pharmacodynamic profile. By moderating peak plasma concentrations and extending drug exposure, the new formulation aims to:
- Improve patient tolerability
- Reduce the frequency of dosing
- Achieve a more consistent therapeutic effect
- Potentially expand its use to broader patient populations
Given that enobosarm has already demonstrated promising efficacy signals in previous studies, the new SPID®-based delivery method could enhance its clinical performance and facilitate regulatory approval in targeted indications.
Advantages of Modified-Release Drug Design
Modified-release (MR) oral formulations offer numerous advantages over immediate-release (IR) dosage forms, particularly for chronic conditions where long-term adherence is critical. Benefits include:
- Reduced Dosing Frequency: MR formulations can maintain therapeutic drug levels for extended periods, reducing the need for multiple daily doses.
- Improved Safety Profile: By smoothing out plasma concentration peaks, MR products can lower the incidence of dose-related adverse effects.
- Patient-Centric Design: Convenience and improved tolerability can enhance adherence and long-term outcomes.
- Optimized Pharmacokinetics: Controlled absorption can improve the match between drug exposure and disease pathophysiology.
In the case of enobosarm, these advantages could be particularly impactful, given the potential for side effects associated with high peak androgen receptor stimulation.
Implications for Phase 3 Development and Commercialization
Veru’s decision to move forward with the SPID®-enabled enobosarm formulation signals confidence in its potential to deliver differentiated clinical benefits. As the company advances toward Phase 3 trials, the following factors will be critical:
- Regulatory Engagement: Early discussions with the U.S. Food and Drug Administration (FDA) and other regulators will help define the clinical and manufacturing requirements for approval.
- Manufacturing Scale-Up: The scalability of SPID®-Technology will be tested as production moves from pilot to commercial volumes.
- Market Differentiation: A unique MR formulation could provide Veru with competitive advantages in both efficacy and patient experience.
- Intellectual Property Protection: Both formulation and manufacturing process patents will be central to protecting the commercial opportunity.
If successful, the product could serve as a flagship example of how precision manufacturing technologies can transform established APIs into novel, market-leading therapies.
A Broader Industry Perspective
The collaboration also highlights a broader shift in pharmaceutical R&D strategy:
- Integration of Advanced Manufacturing Early: Instead of developing a drug with conventional methods and later reformulating it, companies are increasingly investing in advanced delivery technologies during the clinical stage.
- Customization for Specific Populations: Precision manufacturing allows tailoring of pharmacokinetic profiles to match the needs of specific patient groups.
- Platform Potential: Technologies like SPID® are not limited to one drug; they can be applied across multiple therapeutic areas, offering partners a pathway to differentiated portfolios.
For Laxxon Medical, the milestone with Veru validates the versatility and real-world applicability of SPID®-Technology. For Veru, it represents a tangible step toward delivering an improved therapy to patients while strengthening its competitive position in the biopharmaceutical landscape.
In summary, the successful development of a modified-release oral formulation of enobosarm using Laxxon Medical’s SPID®-Technology marks an important advancement for both companies. By combining innovative drug delivery engineering with late-stage clinical expertise, the partnership has produced a formulation designed to maximize therapeutic benefit, minimize side effects, and improve patient adherence. As Veru prepares for Phase 3 studies and eventual commercialization, this collaboration may serve as a model for how targeted technology partnerships can accelerate and optimize pharmaceutical innovation.
