BREAKING: Cybin And Clinilabs Receive DEA License For First-In-Human Clinical Trial Of Psilocybin To Treat Depression

BREAKING: Cybin And Clinilabs Receive DEA License For First-In-Human Clinical Trial Of Psilocybin To Treat Depression

Cybin Inc. CYBN CYBN and Clinilabs Drug Development Corporation (Clinilabsannounced that the U.S. Drug Enforcement Agency (DEA) has granted a Schedule I license to support the first-in-human Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog being developed for the treatment of the major depressive disorder (MDD).

"Obtaining a DEA license for our Phase 1/2a trial is the final step clearing the way to begin dosing participants in our first-in-human study of CYB003. Our rigorous recruitment and enrollment process is well underway, and we are excited to commence dosing of our first cohort of participants,” said Doug Drysdale, CEO of Cybin in a press release procured by Benzinga.

“The DEA license is a federal requirement for any investigators who intend to study, produce, analyze, or otherwise work with Schedule I controlled substances,” Cybin, a biopharmaceutical company focused on psychedelics, explained in the release.

Details Of The Study

The Phase 1/2a trial is a randomized, double-blind, placebo-controlled study evaluating people with moderate to severe MDD.

Participants will receive two administrations (placebo/active and active/active) and a response/remission will be assessed at Week 3 (after the first dose) and at Week 6 (after the second dose).

Using the Montgomery-Asberg Depression Rating Scale, the trial will assess the rapid onset of antidepressant effect on the day of dosing. The study will also evaluate the incremental benefit of the second dose of CYB003 when administered at Week 3 and will provide important PK and safety data to determine a clinical path forward.

An optional period of assessment will help determine the durability of the treatment effect out to 12 weeks. The detailed Phase 1/2a study protocol is available at clinicaltrials.gov under the Identifier number: NCT05385783.

Who Will Participate In The Trials?

Cybin announced that participants in the trial that are currently being treated with antidepressants will be allowed to remain on their antidepressant medication.

This research study is recruiting individuals between the ages of 21 and 55 who have been diagnosed with MDD and who are currently taking an antidepressant medication that is not working to their satisfaction.

Participation includes 11 outpatient visits and two 2-day inpatient stays. Participants who are located within reasonable travel distance to the Clinilabs Eatontown, New Jersey clinical research unit, may pre-screen for study entry at www.depressionpsychedelicstudy.com

What is CYB003?

CYB003 is a deuterated analog of psilocybin, which is part of a family of molecules called indoleamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite psilocin, which can cross the blood-brain barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is designed to potentially address the challenges and limitations of oral psilocybin. Based on preclinical data, CYB003 achieved less variability in plasma levels, faster onset of action, and shorter duration of effect.

Cybin’s team believes CYB003 has the potential to reduce the time and resource burden on patients, providers, and payers and possibly improve the scalability and accessibility of treatment.

Clinilabs Drug Development Corporation

Clinilabs Drug Development Corporation is the only global, full-service contract research organization focused exclusively on central nervous system drug development. The company focuses on the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as ultra-rare diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver high-quality, timely and cost-effective clinical drug development services, to speed new medicines to market.

Photo by Terry Vlisidis on Unsplash

Posted In: ClinilabsCybinDEADoug DrysdaleMDDPsilocybinBiotechCannabisNewsPenny StocksPsychedelicsEmerging MarketsHealth CareContractsLegalMarket-Moving ExclusivesMarkets

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This Company Reports Its Consumer Therapeutics Could Be A Game Changer For People With Skin Problems

This Company Reports Its Consumer Therapeutics Could Be A Game Changer For People With Skin Problems

From allergies and insect bites to sunburns and irritations, the human skin can succumb to several conditions, including acne, psoriasis, blisters, hives, actinic keratosis, rosacea, and carbuncle.

Skin diseases are more prevalent than many think; they currently make up 1.79% of the global disease burden.

Zooming in on the U.S., the American Academy of Dermatology (AAD) reports that 84.5 million Americans — 1 in 4 — are impacted by skin diseases.

In addition to the debilitating physical and emotional impact, skin diseases can have on people, they can also be a financial strain. Skin diseases cost the U.S. healthcare system $75 billion in medical, preventative and prescription, and nonprescription drug costs.

For every three Americans with skin disease, the AAD reports that a dermatologist saw only one.

To make matters worse, the dermatology association also observed that acne has become a significant problem among teenagers  — more than 85% of young people suffer from at least one form of acne.

Demand for effective therapies is growing as cases continue to soar. Luckily, a large number of drugs from companies like AbbVie Inc. ABBV, GSK plc GSK, Eli Lilly and Co. LLY, and Viatris Inc. VTRS have been approved to treat various dermatologic conditions.

These drugs are contributing to the growth of the global dermatology treatment market. The market size was $36.82 billion in 2019 and is projected to reach $63.99 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 12.9% during the forecast period.

For a company like Jupiter Wellness Inc. JUPW, which is ramping up research, development, and trial of new therapies, the market's growth, and need could present opportunities.

The company’s clinical pipeline of prescription skin-care therapeutics addresses health conditions such as eczema, burns, herpes, cold sores, and skin cancer.

Founded in 2018, Jupiter Wellness is engaged in early-stage manufacturing, distribution, and marketing of consumer products.

A Look At Jupiter Wellness’s Consumer Products 

The Jupiter, Florida-based company’s clinical pipeline includes JW-100, a novel topical formulation containing CBD and aspartame for treating eczema, dermatitis, and actinic keratosis.

Also in the pipeline is JW-300, a prescription product for treating burns, and JW-400, a nonprescription lotion/lip balm for treating symptoms of cold sores.

Eczema (JW-100):  Topical treatment for atopic dermatitis (eczema)

According to Jupiter Wellness, studies showed that JW-100 cleared or reduced eczema symptoms after two weeks of use. Results suggest that JW-100 may potentially prove superior to existing prescription drugs.

A Phase 3, double-blind, placebo-controlled multicenter trial is underway to evaluate the superiority of JW-100 to Eucrisa a Food and Drug Administration (FDA)-approved topical drug) in mild to moderate eczema.

Female sexual wellness (RJ-101):  Topical treatment for female libido loss

The company’s studies showed that RJ-100 increased nipple erection, sensitivity, and genital lubrication in clinical trials conducted on normal patients and those with nipple neuropathy.

Jupiter Wellness hopes to launch RJ-101 in 2023 and anticipates it will be sold as an over-the-counter (OTC) treatment for female sexual dysfunction and as a consumer product for general sexual wellness and pleasure.

Hair Loss (Minoxidil Booster): Topical treatment designed to improve Minoxidil efficacy

The company reports minoxidil is the only FDA-approved topical drug for treating common hair loss (androgenetic alopecia). 

The company says clinical studies of Minoxidil Booster have shown it increases the enzymes needed for minoxidil to work, sulfotransferase enzymes, by up to seven times over a two-week period.

Minoxidil Booster has been licensed to Taisho Pharmaceutical Holdings, a $2.6 billion company and Japan’s leading seller of minoxidil products. It expects to launch the product commercially in 2023.

It has also been licensed to India-based Cosmofix Technology and Sanpellegrino Cosmetics and is expected to be launched soon.

Psoriasis and vitiligo (Photocil): Topical treatment for psoriasis and vitiligo

 Jupiter Wellness says Photocil safely and effectively permits phototherapy treatments at home by blocking harmful radiation and allowing the passage of therapeutic ultraviolet (UV) radiation.

It is anticipated that Photocil will be available online in the U.S. in the fourth quarter of 2022 as an FDA-approved over-the-counter product under a United States Pharmacopeia (USP) monograph for psoriasis and vitiligo.

The company reports that clinical trial results showed that Photocil cream acts as a barrier to nontherapeutic radiation from the sun when skin is exposed to direct daylight. 

Burns (JW-300): Topical treatment of first-degree burns and sun exposure

Jupiter Wellness reports that JW-300 was shown to significantly lower the incidence of burns in patients exposed to UV radiation.

JW-300 is being evaluated for sale as an after-sun consumer product to complement the company’s NoStingz sunscreen — topical protection from jellyfish, sea lice, and ultraviolet A (UVA)/ultraviolet B (UVB) rays — and legacy sun care product lines.

Cold sores (JW-400): Topical treatment for herpes labialis (cold sores)

Jupiter Wellness revealed that phase 1, a double-blind placebo-controlled investigational study in Europe and Asia with FDA-similar protocols initiated in preparation for FDA Investigational New Drug (IND) filing.

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice.

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Posted In: Jupiter WellnessPartner ContentBiotechPenny StocksGeneral

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