Biotech Requests Pre-IND Meeting with the US FDA: Jupiter Wellness: NASDAQ: JUPW JW-100 Clinical Program Treatment for Mild to Moderate Eczema
Following receipt of a Pre-Assignment number from the FDA Jupiter Wellness requests Pre-IND meeting
JUPW a developer of enhanced skin care therapeutics and treatments focused on the endocannabinoid system today announced it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its JW-100 drug development program the treatment of patients with mild to moderate Eczema.
The benefits of holding a pre-IND meeting are to receive early FDA feedback on proposed preclinical and clinical study plans confirming strategy for IND submission.The FDA’s statistics show that this can significantly reduce overall development times which impacts time to market.
The Global Eczema (atopical dermatitis) treatment market is valued at $10 billion and expected to grow at a CAGR of 13% from 2020-2025. 31.6 million Americans or roughly 10% of the population suffer from Eczema. 86% are not satisfied with their current treatment.
Through the Company’s research and development program, it has shown that in a double-blinded, placebo controlled clinical trial, JW-100 significantly reduced ISGA scores in 50% of adult patients suffering from eczema and JW-100 cleared or reduced eczema following 2 weeks of use.
– Developer of CBD Treatments for the Multi-Billion Dollar Skin Care Market.
– Multiple Clinical Studies Underway on Company’s Proprietary Products.
– LOI Signed to Acquire JustCBD and its Affiliates with Over 300 SKUs.
– Highly Qualified Management with Extensive Accomplishments in Place.
– Investment in Theme Park Business Sees Surge in Recent Business as the Pandemic Declines.
Jupiter Wellness, Inc. (NASDAQ: JUPW) is a leading developer of cannabidiol (CBD) based medical therapeutics and wellness products. The JUPW clinical pipeline of prescription CBD-enhanced skin care therapeutics address indications including eczema, burns, herpes cold sores, and skin cancer. JUPW generates revenues from a growing line of proprietary over-the-counter skincare products including its flagship CaniSun
sunscreen and other wellness brands sold through its robust distribution platform.
JUPW is NASDAQ listed and has an attractive share structure with only
11,410,188 shares currently outstanding.
– JUPW Advances Clinical Pipeline of CBD-Based Topical Treatments
On April 29th JUPW announced an update on its clinical pipeline of CBD-based therapeutic topical formulations including JW-100 for the treatment of eczema, JW-200 for skin cancer, JW-300 for burns, and JW-400 for herpes cold sores.
Commenced Patient Enrollment for Skin Cancer: Study Completion Expected Q4 2021
The JUPW JW-200 is designed to provide action and relief in the treatment of Actinic Keratosis (AK), the most common precancer that forms on skin as a result of exposure to ultraviolet (UV) rays. The objective of this double blinded, placebo-controlled study is to evaluate the efficacy of JW-200 in both the treatment and prevention of disease, with a primary efficacy endpoint of the percentage of patients with complete clearance of AK lesions. An estimated 120 adults diagnosed with AK will be recruited, with an expected study completion date of Q4 2021.
The Skin Cancer Foundation estimates 58 million Americans have one or more AK lesions which appear as raised, scaly discolored patches on sun-exposed skin. Left untreated, approximately 20% of AK lesions progress to squamous cell carcinoma. The skin cancer treatment market was $8.19 billion 2019 and is estimated to reach $14.55 billion by 2027.
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.
The closing of the transaction is subject to the completion of due diligence, the negotiation and execution of definitive transaction agreements, availability of financing and any necessary regulatory approvals. There can be no assurance that the transaction will be consummated. A condition of the closing of the transaction is that JUPW will enter into a 3-year management operating agreement whereby key members of the JustCBD management team will be retained by JUPW. In addition, it is anticipated that JustCBD will receive representation on the JUPW board of directors.
JustCBD is a leading global manufacturer, retailer and wholesaler of consumer CBD products with over 300 SKUs across a wide variety of categories. Preliminary unaudited 2020 consolidated financial statements of JustCBD and its affiliates show approximately $28 million of revenue. JustCBD has engaged a leading SEC audit firm to complete its audit, which audit is in process.
JUPW management believes this acquisition will be highly accretive to JUPW and its shareholders and puts the Company at the forefront of CBD consumer related products on the market today.
– SRM Division Sees Significant Monthly Sales Growth as Global Theme Parks Set to Reopen
On March 11th JUPW announced that SRM Entertainment was on track for the month of March to produce its highest monthly sales since the wholly owned subsidiary was acquired in December of 2020.
SRM designs, manufactures, and sells creative products and services globally to customers including Fortune 500 companies with a focus in the hospitality industry and the world’s most iconic theme parks in locations including Orlando, Florida, Southern California, and other high profile cities worldwide.
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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