Eight-participant pharmacokinetic study shows rapid systemic appearance following administration of 5 mg and 15 mg Quicksome™ sublingual formulations

Company Website: https://www.themorelife.company
TORONTO -- (Business Wire)

The More Life Company Corp. (the “Company” or “MLCO”), (CSE: MLCO) (OTC: TMLCF), is pleased to announce results from an exploratory eight-participant human pharmacokinetic study conducted with third-party medical personnel to evaluate United States Pharmacopeia (“USP”) grade testosterone formulated using the Company’s patented Quicksome™ sublingual delivery technology.

The study showed rapid systemic appearance of USP testosterone following Quicksome administration, with substantial increases in measured serum testosterone observed within minutes of dosing. Peak serum testosterone concentrations were generally observed within approximately 10 to 30 minutes following administration, with six of eight participants reaching their observed peak concentration at approximately 20 minutes.

Substantial increases in serum testosterone from individual pre-dose baselines were observed in all eight participants. Participants ranged in age from 28 to 71 years. Six received a 15 mg Quicksome formulation, and two received a 5 mg formulation.

Among the six participants receiving the 15 mg formulation, individual average pre-dose serum testosterone concentrations ranged from approximately 311 ng/dL to 432 ng/dL. Individual observed peak concentrations ranged from 1,436 ng/dL to 5,981 ng/dL.

Substantial systemic exposure was also observed in both participants receiving the lower 5 mg formulation. The two participants reached observed peak serum testosterone concentrations of 5,263 ng/dL and 3,616 ng/dL, respectively, from average pre-dose concentrations of approximately 626 ng/dL and 272 ng/dL.

Consistent with the observed rapid sublingual delivery profile, serum testosterone concentrations rose quickly and declined progressively following peak exposure. By approximately three hours, concentrations for most participants had returned toward their individual pre-dose levels, with six-hour final measurements generally remaining near baseline. The resulting rapid-rise and subsequent decline profile provides the Company with valuable pharmacokinetic information to guide formulation optimization and the evaluation of future dosing strategies.

“These results are important to us well beyond testosterone,” stated Dennis Hancock, President and Chief Executive Officer of The More Life Company. “Our objective with Quicksome is to change how important molecules can be formulated and delivered, particularly where conventional approaches create challenges around absorption, stability, dosing or the need for injection. Seeing substantial systemic exposure from relatively small quantities of USP testosterone gives us meaningful human data to build from. As we advance our work with testosterone alongside current formulation development involving estradiol and progesterone, we believe hormones represent an important area where Quicksome may create differentiated, needle-free delivery opportunities.”

STUDY DESIGN AND OBSERVATIONS

The small-sample exploratory study enrolled eight adult male participants ranging in age from 28 to 71 years. Six participants received a single 15 mg Quicksome USP testosterone tablet, and two participants received a single 5 mg tablet.

Participant-facing study procedures, including dosing and serial blood collection, were conducted by third-party medical personnel under medical oversight. The Company’s role included development of the Quicksome formulation and supporting evaluation of the resulting pharmacokinetic data.

Two serum testosterone measurements were collected before dosing to establish individual pre-dose concentrations. Serial blood samples were subsequently collected throughout the early post-dose period and over a six-hour observation window.

The intensive early sampling schedule was designed to characterize the speed of systemic appearance, approximate time of peak serum concentration, subsequent decline and return toward baseline.

Six participants reached their observed maximum serum testosterone concentration at approximately 20 minutes following administration. One participant reached the observed maximum at approximately 10 minutes and one at approximately 30 minutes.

“The speed and magnitude of the serum testosterone response observed following administration were notable,” said Sanjeev Goel, MD, an advisor to the Company who provided medical oversight for the study. “Across the participants, testosterone concentrations increased rapidly following dosing, with peak concentrations generally observed within the first 10 to 30 minutes. The subsequent decline toward pre-dose concentrations over the following several hours provided a clear pharmacokinetic profile that can inform further investigation.”

The study also provided practical formulation information. Tablet dissolution generally occurred within approximately three to eight minutes, with one participant experiencing a longer dissolution time of approximately 12 minutes. One participant delayed administration by approximately 10 minutes, which was accounted for when assessing the timing of that participant’s post-dose response.

FORMULATION AND DOSE LEARNING

The study evaluated both 5 mg and 15 mg formulations to begin understanding the relationship between API loading and systemic exposure.

Notably, clear and rapid systemic exposure was observed in both participants receiving the 5 mg formulation despite their receiving one-third of the API contained in the 15 mg formulation.

The Company considers this an important formulation-development observation and intends to further investigate lower-dose performance, dose proportionality, total systemic exposure and formulation characteristics as part of continued Quicksome optimization.

The current study was not designed or powered to establish equivalence between the 5 mg and 15 mg formulations, and the Company is not drawing conclusions regarding optimal dose based on the limited dose groups evaluated.

“This study gives us considerably more information than simply confirming systemic exposure,” said Richa Mandalay, Director of Research and Development at The More Life Company. “The intensive sampling schedule allowed us to characterize the early systemic exposure curve, approximate peak timing, duration of exposure and return toward baseline. Evaluating both 5 mg and 15 mg formulations also provided important preliminary information around dose loading and formulation performance. We can now use these human data to refine tablet dissolution, investigate dose proportionality and further optimize Quicksome formulations for testosterone and other hormone applications.”

BUILDING A BROADER HORMONE DELIVERY PLATFORM

The Company is applying knowledge generated through its testosterone work to a broader Quicksome hormone formulation program.

In addition to testosterone, current formulation development includes estradiol and progesterone. These programs are intended to evaluate the potential application of Quicksome across hormone molecules where precision dosing, rapid systemic delivery, formulation stability, patient convenience and needle-free administration may provide opportunities for differentiated delivery approaches.

The Company believes the testosterone study provides an important human pharmacokinetic dataset that can inform this broader development work, including formulation design, API loading, tablet dissolution and administration protocols.

The rapid-rise and subsequent decline profile observed in the testosterone study also provides information that may support future investigation of controlled, repeatable dosing strategies rather than prolonged depot delivery.

SIGNIFICANCE FOR QUICKSOME™

Quicksome™ is the Company’s patented desiccated liposomal formulation and delivery technology designed to formulate active ingredients for administration through the oral mucosa.

The Company believes the significance of the testosterone study extends beyond the specific molecule evaluated.

USP testosterone provides a useful development molecule because serum concentrations can be measured repeatedly following administration, allowing the Company to characterize the timing, magnitude and duration of systemic exposure generated by a Quicksome formulation.

During the study, the following was observed:

• Rapid systemic appearance of USP testosterone following Quicksome administration.
• Substantial increases from individual pre-dose serum testosterone concentrations across all eight participants.
• Observed peak concentrations generally occurring approximately 10 to 30 minutes following administration, with six of eight participants reaching their observed peak at approximately 20 minutes.
• Clear systemic exposure at both the 5 mg and 15 mg dose levels.
• Progressive decline following peak exposure, with concentrations generally returning toward individual pre-dose levels within several hours.

These findings provide the Company with additional human data to support continued development of Quicksome as a formulation and delivery platform for molecules where rapid systemic delivery, optimized API loading, needle-free administration, formulation stability or avoidance of gastrointestinal delivery may represent potential opportunities.

NEXT STEPS

The Company intends to use the study results to guide continued optimization of its Quicksome testosterone formulation, including further evaluation of dose loading, tablet dissolution, consistency of systemic exposure and potential repeat-dosing strategies.

The Company also intends to apply knowledge generated through this work to its broader Quicksome development programs involving hormones, peptides and other bioactive molecules.

The exploratory study was designed to characterize systemic exposure and pharmacokinetic behavior following Quicksome administration. Given the exploratory design and small sample size, the findings are preliminary and are intended to inform continued formulation development and future study design. It was not designed to evaluate clinical efficacy, establish an optimal therapeutic dose, determine absolute bioavailability, or demonstrate equivalence or superiority to injectable, oral, buccal or other sublingual testosterone products.

ABOUT QUICKSOME™

Quicksome™ is The More Life Company’s patented desiccated liposomal formulation and delivery technology. The platform utilizes proprietary formulation approaches and stabilizing molecules to encapsulate and formulate active ingredients into efficient dosage formats designed to support rapid delivery, precision dosing and improved formulation performance.

The Company is advancing Quicksome across human health applications where formulation, stability, bioavailability, dose efficiency, convenience and needle-free delivery represent potential opportunities for innovation.

ABOUT THE MORE LIFE COMPANY CORP.

The More Life Company Corp., formerly Mountain Valley MD Holdings Inc., is building a world-class organization centered around the implementation, licensing and reselling of key technologies and formulations:

• patented Quicksome™ oral formulation and delivery technologies;
• patented Quicksol™ solubility formulation technology; and
• licensed product reseller of Agrarius™, a novel agricultural plant signaling technology.

Consistent with its vision towards “More Life”, the Company applies its owned and licensed technologies to its work for advanced delivery of molecules for human and husbandry animal applications, including the development of products for pain management, weight loss, energy, focus, sleep, anxiety, and more. Additionally, the Company’s work with Agrarius is focused on generating a positive impact on crop yields and reducing fertilizer usage.

The Company’s patented Quicksome™ technology utilizes proprietary formulations and stabilizing molecules to encapsulate and formulate active ingredients into highly efficient product formats. The result is a new generation of product formulations that could be capable of delivering nutraceutical and drug molecules into the body faster, with greater impact, efficiency and accuracy.

The Company’s patented Quicksol™ technology covers all highly solubilized macrocyclic lactones that could be effectively applied in multiple viral applications that could positively impact human and animal health globally.

The Company’s licensed Agrarius™ agricultural plant signaling technology is designed to be applied to crops to naturally increase yields, reduce fertilizer usage, and increase general resilience to pests and climate change.

For more Company information and contact details, visit www.themorelife.company.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Certain statements contained in this news release may constitute forward-looking information within the meaning of applicable securities laws. Forward-looking information is often, but not always, identified by words such as “anticipate”, “believe”, “continue”, “estimate”, “expect”, “intend”, “may”, “plan”, “potential”, “should”, “will” and similar expressions, or statements that events, conditions or results “can”, “could”, “may”, “should” or “will” occur or be achieved.

Forward-looking information contained in this news release includes, but is not limited to, statements regarding the Company’s continued development and optimization of Quicksome™ formulations; further evaluation of testosterone dose loading, tablet dissolution, dose proportionality, systemic exposure and potential repeat-dosing strategies; the application of knowledge generated from the testosterone study to estradiol, progesterone, peptides and other bioactive molecules; the potential application of Quicksome™ to hormone and other needle-free delivery opportunities; and the Company’s plans for further formulation development, research and commercialization activities.

Forward-looking information is based on management’s current expectations, assumptions and beliefs as of the date of this news release and is subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or developments to differ materially from those expressed or implied by such forward-looking information. These factors include, among others, the results of future research, formulation and validation activities; the ability to reproduce or expand upon results observed in exploratory studies; regulatory requirements and approvals applicable to future development or commercialization activities; the availability of capital, commercial partners and other resources; and other risks associated with the development and commercialization of pharmaceutical, nutraceutical and delivery technologies.

There can be no assurance that the Company’s research and development activities will result in commercially viable products, that future studies will reproduce results observed to date, or that any Quicksome™ formulation will receive applicable regulatory authorization or achieve commercial adoption.

Readers are cautioned not to place undue reliance on forward-looking information. Any forward-looking information contained in this news release represents the Company’s expectations as of the date hereof and is subject to change after such date. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities legislation.

Neither the CSE nor OTC Markets Group has reviewed or approved the contents of this press release.

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Contacts:

For further information:

Dennis Hancock
President and Chief Executive Officer
The More Life Company Corp.
Investor Relations: 647-725-9755
Email: info@themorelife.company

Source: The More Life Company Corp.