Nutriband Subsidiary, 4P Therapeutics LLC, Conducts Phase 1b Clinical Study for Sorrento Therapeutics, Inc. on Lymphatic Etanercept Delivery in Rheumatoid Arthritis Patients With Results To Be Presented at the 2022 American College of Rheumatology Conference

Rhea-AI Summary

Nutriband Inc. (NASDAQ:NTRB) announced its subsidiary, 4P Therapeutics, completed a Phase 1b clinical study for Sorrento Therapeutics (NASDAQ:SRNE). Results will be presented at the American College of Rheumatology (ACR) Convergence 2022 on November 13, 2022, highlighting significant improvements in rheumatoid arthritis disease measures at 50% of the standard dose. The study emphasizes the potential of the Sofusa lymphatic delivery platform for treating autoimmune diseases and showcases 4P Therapeutics' capabilities in advancing drug delivery products.

Positive

• Successful Phase 1b clinical study results for Sorrento's lymphatic delivery platform.
• Significant improvements in rheumatoid arthritis measures at half the standard dose.
• Highlights 4P Therapeutics' clinical regulatory capabilities.

Negative

• None.

ORLANDO, FL / ACCESSWIRE / October 26, 2022 / Nutriband Inc. (the "Company") (NASDAQ:NTRB) (NASDAQ:NTRBW) today announced that its subsidiary, 4P Therapeutics LLC ("4P Therapeutics"), has conducted a Phase 1b clinical study for Sorrento Therapeutics, Inc. ("Sorrento") (NASDAQ:SRNE) with results to be presented at the American College of Rheumatology (ACR) Convergence 2022 Conference on November 13, 2022 as a poster abstract entitled "Lymphatic Delivery of Etanercept Achieves Significant Improvements in Rheumatoid Arthritis Disease Measures at 50% of the Standard Dose for Patients with an Inadequate Response to Subcutaneous Injections."

"We are excited about these proof of concept clinical results and the development of Sorrento's Sofusa lymphatic delivery platform for treatment of autoimmune diseases such as rheumatoid arthritis to provide hope for those patients who do not respond adequately to conventional biologic injections," said Alan Smith, Ph.D., President, 4P Therapeutics. "This success highlights the clinical regulatory capabilities of 4P Therapeutics in advancing drug delivery products for our partners."

The abstract is available at https://acrabstracts.org/abstract/lymphatic-delivery-of-etanercept-achieves-significant-improvements-in-rheumatoid-arthritis-disease-measures-at-50-of-the-standard-dose-for-patients-with-an-inadequate-response-to-subcutaneous-injectio/

About 4P Therapeutics

4P Therapeutics is a subsidiary of Nutriband, Inc. primarily focused on the research and development of novel drug delivery technologies and therapeutics. 4P develops products that meet the needs of patients, physicians and payers (the 4P's). A key company focus and area of expertise is in the development of transdermal products based on a wide range of technologies from conventional small molecule patches to novel transdermal technologies for delivery of proteins, peptides, macromolecules and biologics. Transdermal delivery of commercially available drugs or biologics that are typically delivered via injection has the potential to improve safety, efficacy and therapeutic outcomes associated with these treatments.

4P specializes in accelerating early stage product development from initial concept to proof-of-concept in humans, by moving quickly from the establishment of preclinical feasibility to demonstration of product feasibility in human clinical trials. 4P supports partners throughout the product development program with specific expertise in planning and execution of the clinical research program as well developing and executing the regulatory plan to meet the requirements of the United States Food and Drug Administration (FDA).

The Company's website is www.4ptherapeutics.com. Any material contained in or derived from 4P Therapeutics' website or any other website is not part of this press release.

About Nutriband Inc.

Nutriband Inc. (NASDAQ:NTRB) is primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA^™ abuse deterrence technology. Nutriband's AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico, and Australia.

The Company's website is www.nutriband.com. Any material contained in or derived from the Company's website or any other website is not part of this press release.

About Sorrento Therapeutics Sofusa Business Unit

The Sofusa Business Unit is a wholly owned division of Sorrento based in Atlanta, Georgia and is focused on lymphatic drug development with pre-clinical, analytical, clinical development, and device manufacturing capabilities. The Sofusa platform is a novel microneedle technology that delivers both small and large molecule drugs through the skin and into lymphatic capillaries resulting in significantly higher drug concentrations to immune system drug targets over greater time periods than traditional injections or infusions. Drug targets for many diseases of the immune system (e.g., autoimmune diseases and cancer) reside in the lymphatic system and lymph nodes. In multiple pre-clinical models, Sofusa's proprietary nanotopography-draped microneedle system has consistently demonstrated the ability to improve therapeutic responses by delivering over 40-fold increases in drug concentration to targeted lymph nodes when compared to traditional subcutaneous injections or intravenous infusions. The Sofusa Business Unit is currently conducting human proof of concept studies in autoimmune disease and in cancer.

About Sorrento Therapeutics, Inc.

Sorrento Therapeutics, Inc. (Nasdaq:SRNE) is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as next-generation tyrosine kinase inhibitors ("TKIs"), fully human antibodies ("G-MAB™ library"), immuno-cellular therapies ("DAR-T™"), antibody-drug conjugates ("ADCs"), and oncolytic virus ("Seprehvec™"). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including STI-1558, COVISHIELD™ and COVIDROPS™; and diagnostic test solutions, including COVIMARK™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin ("RTX"), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com. Any material contained in or derived from Sorrento's website or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,'' "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including the Company's ability to develop its proposed abuse deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Phase 1b study might not be replicated), as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Annual Report on Form 10-K for the year ended January 31, 2022 and subsequent Quarterly Reports on Form 10-Q, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

For more information, contact:

Investor Relations
RedChip Companies
Dave Gentry
Dave@redchip.com
1-800-RED-CHIP (733-2447)
407-491-4498

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

SOURCE: Nutriband Inc.

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FAQ

What were the results of the Phase 1b study by Nutriband's subsidiary 4P Therapeutics?

The Phase 1b study demonstrated significant improvements in rheumatoid arthritis measures at 50% of the standard dose.

When will the results of the study be presented?

The results will be presented at the American College of Rheumatology Conference on November 13, 2022.

What is the significance of the Sofusa lymphatic delivery platform?

The Sofusa platform offers a novel approach to drug delivery for autoimmune diseases, enhancing efficacy at lower dosages.

How does the lymphatic delivery impact future treatments for rheumatoid arthritis?

This delivery method could provide more effective treatments for patients who do not respond adequately to traditional biologic injections.