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JUPITER, FL / ACCESSWIRE / SEPTEMBER 4, 2021 / Jupiter Wellness, Inc. (NASDAQ:JUPW), today announced it has requested an IND number from the US Federal Drug Administration in preparation for a pre-IND submission to review preclinical and clinical studies for the use of JW-100 in the treatment of patients with mild to moderate eczema.

The preparation of the pre-IND briefing document has been co-ordinated by a team of scientific, clinical and regulatory experts at Applied Biology Inc., (Irvine, CA) in concert with pharmaceutical and manufacturing expertise at Jupiter Wellness Inc.

Jupiter Wellness previously reported that in a double-blinded, placebo controlled clinical trial of 55 patients using JW-100 was shown to significantly reduce ISGA scores in 50% of adult patients suffering from eczema after two weeks of use.

“The request of an IND number and filing of an IND is a natural step forward as we expand our clinical program and ultimately seek FDA approval for a prescription medicine for the treatment of eczema” said Dr Glynn Wilson, Chief Scientific Officer at Jupiter Wellness. “Jupiter Wellness is committed to providing rapid-and-consistent relief for the majority of people suffering from eczema.”.

Preparing for Upcoming IND Meeting with U.S. FDA for Eczema Phase I/II Study

JUPW is preparing for a meeting in Q3 2021 with the U.S. Food and Drug Administration (FDA) regarding the Company's Investigational New Drug (IND) application that it expects to file. JUPW will propose its clinical protocol for a Phase I/II study based on the efficacy and safety shown in the recently completed exploratory study of JW-100 for the treatment of atopic dermatitis (eczema). The study showed that JW-100 cleared or reduced eczema following two weeks of use in more than half of the subjects, achieving ISGA clear or almost clear (1 or 2) with at least a 2-grade improvement from baseline after treatment, versus 20% and 15% in the CBD-only and placebo arms.

The global eczema market is valued at $10 billion and is expected to grow at a CAGR of 13% through 2025. Ten percent of the U.S. population, or 31.6 million people, have eczema, and according to NationalEczema.org, 86% of people are not satisfied with their current treatment.

JW-400 for Treatment of Herpes Cold Sores Expected to Commence Recruitment Q4 2021

The double blind, placebo controlled JUPW study is now preparing for recruitment of 40 patients with recurrent herpes labialis infection (HSV) who had their initial infection more than one year prior. The primary endpoint is the duration of the herpes labialis episode. The herpes simplex virus treatment market was $4.8 billion in 2017. Nearly half of Americans age14-29 have HSV-1, known as the cold sore virus.

  • JUPW Enters into Letter of Intent to Acquire JustCBD and its Affiliates

On April 20th JUPW announced it has signed a non-binding Letter of Intent with JustCBD and its affiliates to purchase 51% of JustCBD for $30 million in cash. Per the Letter of Intent, JustCBD would also receive a put option to sell, at its sole discretion, the remaining 49% of JustCBD to JUPW for an additional $30 million in a combination of JUPW common stock (not to exceed 25% of the outstanding shares of JUPW) and preferred shares, both valued at $5.00 per share.

JUPW made a strategic decision to make an investment in the hard-hit theme park and hospitality industry and acquire SRM to keep a quality operation active through the pandemic. With hospitality venues and theme parks starting to move towards fully re-opening, JUPW is seeing a significant increase in purchase orders and shipments.

For additional information on Jupiter Wellness, Inc. (JUPW) visit www.jupiterwellnessinc.com

All products mentioned in this article are THC-free and compliant with the 2018 farm Bill

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Disclaimer/Safe Harbor:

These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

SOURCE: CorporateAds.com

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