Jupiter Wellness Applies for IND number from the US Food and Drug Administration

Rhea-AI Summary

Jupiter Wellness (NASDAQ:JUPW) is moving forward with its clinical program for JW-100, targeting the treatment of mild to moderate eczema. On August 16, 2021, the company announced it has requested an IND number from the US FDA for a pre-IND submission regarding preclinical and clinical studies. A recent double-blinded placebo-controlled trial showed JW-100 significantly reduced ISGA scores in 50% of patients after just two weeks. The development is supported by expertise from Applied Biology Inc. and aims for FDA approval to provide effective eczema relief.

Positive

• Successful double-blinded trial showed JW-100 reduced ISGA scores in 50% of patients after two weeks.
• Requesting an IND number is a significant step toward FDA approval for JW-100.

Negative

• None.

Following positive results from the JW-100 investigator initiated trials for Eczema, Jupiter Wellness to commence US FDA program

JUPITER, FL / ACCESSWIRE / August 16, 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."

About Jupiter Wellness
Jupiter Wellness, Inc. (NASDAQ:JUPW) is a leading developer of skin care therapeutics and treatments. The Company's product pipeline of enhanced skin care therapeutics focuses on the endocannabinoid system to address indications including eczema, burns, herpes cold sores, and skin cancer. Jupiter generates revenue from a growing line of proprietary over-the-counter skincare products including its CaniSun™ sunscreen and other wellness brands sold through www.cbdcaring.com.

For additional information, please visit www.jupiterwellness.com. The Company's public filings can be found at www.Sec.gov.

Safe Harbor Statement
To the extent any statements contained in this presentation of Jupiter Wellness, Inc. (the "Company") contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 and the information that are based upon beliefs of, and information currently available to, the company's management as well as estimates and assumptions made by the company's management. These statements can be identified by the fact that they do not relate strictly to historic or current facts. When used in this presentation the words "estimate," "expect," intend," believe," plan," "anticipate," "projected" and other words or the negative of these terms and similar expressions as they relate to the company or the company's management identify forward-looking statements. Such statements reflect the current view of the company with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to the company's industry, its operations and results of operations and any businesses that may be acquired by the company. Should one or more of these risks or uncertainties materialize, or the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, the company cannot guarantee future results, performance, or achievements. Except as required by applicable law, including the security laws of the United States, the company does not intend to update any of the forward-looking statements to conform these statements to actual results.

Investor & Public Relations Contact Info
Phone: 561-244-7100
Email: info@JupiterWellness.com

SOURCE: Jupiter Wellness, Inc.

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https://www.accesswire.com/659778/Jupiter-Wellness-Applies-for-IND-number-from-the-US-Food-and-Drug-Administration

FAQ

What is the significance of Jupiter Wellness requesting an IND number for JW-100?

Requesting an IND number is a critical step for Jupiter Wellness to move forward with its clinical trials for JW-100, aimed at treating eczema.

When did Jupiter Wellness announce progress in its JW-100 trials?

Jupiter Wellness announced its plans on August 16, 2021.

What were the results of the JW-100 clinical trials?

In a clinical trial, JW-100 significantly reduced ISGA scores in 50% of adult patients suffering from eczema after two weeks.

What does the IND number request mean for Jupiter Wellness?

The IND number request indicates that Jupiter Wellness is preparing to submit a pre-IND application to the FDA, which is essential for gaining approval to conduct further clinical studies.

What is Jupiter Wellness's focus in their product development?

Jupiter Wellness focuses on skin care therapeutics, particularly treatments targeting the endocannabinoid system for conditions like eczema.