Mycrodose Therapeutics Successfully Delivers Both Macro and Microdose Levels of Psilocin Using Core Drug Delivery Technologies

Mycrodose Therapeutics Successfully Delivers Both Macro and Microdose Levels of Psilocin Using Core Drug Delivery Technologies

Mycrodose Therapeutics showed the ability to synthesize and stabilize psilocin in their laboratory for use in their IP-protected drug delivery systems. The company successfully delivered in vitro both macro and microdose levels of psilocin through human skin using their patch and lozenge technologies.

Mycrodose Therapeutics (“Mycrodose”), a leading US pharmaceutical company specializing in the development of advanced drug delivery (ADD) technologies utilizing DEA Schedule I & III drugs and other compounds, announced today their successful in vitro pre-clinical research study showing the ability to synthesize and stabilize psilocin, the active pharmaceutical ingredient (API), in-vitro through human skin using their proprietary transdermal patch and lozenge technology. Mycrodose’s in vitro studies also showed that the company’s technologies were able to deliver both macro and microdose levels of psilocin into circulation.

“With the upgrade to our in vitro penetration test setup, we are now researching transdermal drug delivery beyond the 1-day patch, extending up to one-week delivery,” says Frank Kochinke, Chief Science Officer, Mycrodose Therapeutics. “However, thinking the opposite way, larger doses within a shorter time interval, essentially macrodosing is potentially possible. Our preliminary results suggest that larger doses, such as a standard macrodose, of psilocin can be delivered via our proprietary transdermal and transmucosal technologies. The technological hurdles that remain are to convert the exciting results into a 2-year shelf-life product. To accomplish that we are enhancing our analytical capabilities and implementing stability-indicating assays as well as using upgraded LC/MS equipment to research psilocin’s metabolites and degradation products. These are needed to be prepared for our projected clinical studies evaluating the prototypes for several indications in large mental and general health market segments,” Kochinke continued.

Mycrodose Therapeutics’ preclinical results show that the active compound psilocin, both extracted from psilocybin mushrooms and synthesized at Mycrodose’s laboratory to cGMP standards, can be stabilized before being delivered transdermally and transmucosally, through the company’s controlled and sustained-release drug delivery technology.

“We have successfully synthesized psilocin, developed a psilocin transdermal drug delivery system and performed in vitro permeation studies with our semi-automatic permeation instrument. We utilized human skin for in-vitro studies, which is donated from local surgery centers and dermatomed in-house. It is important to note all of the aforementioned processes were done in-house, at our research facility.” says Bryan Arrayales, Director of R&D, Mycrodose Therapeutics.

With respect to the instability of psilocin, Mycrodose Therapeutics is currently on track to further stabilize psilocin inside its respective drug delivery systems to increase the APIs shelf life. Through rigorous studies, Mycrodose is able to deliver micro and macro amounts of psilocin giving the company multiple treatment options with respect to patient demand.

The results of the research further show that the company’s ability to control and sustain the delivery of psilocin is possible by increasing or decreasing permeation rates through human skin. The research also showed that a larger dose, a macro dose level, of psilocin can be delivered effectively using the company’s patch and lozenge technology.

Future plans of the company include the synthesis of LSD to be used in the development of an LSD transdermal and sublingual drug delivery system.

About Mycrodose Therapeutics

Mycrodose Therapeutics Inc. is a U.S.-based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. Mycrodose’s state-of-the-art laboratory includes a transdermal department with full in-vitro and analytical capacities that allows for all intellectual property and proprietary data to remain in-house. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom

Chief Operating Officer

Mycrodose Therapeutics

Email: Patrick@MycrodoseThera.com

Phone: 1-619-494-1367

Website: www.MycrodoseThera.com

HAVN Life Enters Into Distribution Agreement With Mycrodose Therapeutics for U.S. Market

HAVN Life Enters Into Distribution Agreement With Mycrodose Therapeutics for U.S. Market

The Agreement allows HAVN Life to export naturally derived psilocybin from its Jamaica facility and grows roster of supply partners in the U.S. market

Vancouver, BC – HAVN Life Sciences Inc. (CSE: HAVN) (OTC: HAVLF) (FSE: 5NP) (the “Company” or “HAVN Life”) a biotechnology company pursuing standardized extraction of psychedelic compounds for investigational research as potential APIs to support brain health and cognitive function, is thrilled to announce its entry into an exclusive U.S. Distribution Agreement (the “Exclusive Distribution Agreement”) with California-based Mycrodose Therapeutics Inc. (“Mycrodose”), a leading pharmaceutical company in the U.S. specializing in the research and development of advanced drug delivery systems utilizing DEA Schedule I, II and III drugs and other compounds aimed at treating cancer related conditions, mental health, and cognitive degenerative diseases.

HAVN Life and Mycrodose have entered into the Exclusive Distribution Agreement to facilitate the import of HAVN Life’s naturally derived GMP psilocybin into the United States for authorized research purposes. The Exclusive Distribution Agreement allows HAVN Life & Mycrodose to provide naturally derived GMP psilocybin to research institutions/researchers within the U.S. at competitive prices, which should assist with alleviating the supply chain issues currently facing researchers who are unable to find GMP psilocybin at an affordable price.

“HAVN Life is kicking off 2022 with strong partnerships in both our research and retail divisions, and we are very excited to start fulfilling purchase orders for our research customers with our new U.S. distribution partner, Mycrodose Therapeutics,” says HAVN Life CEO, Tim Moore. “We’ve been working closely with Chad and his team, and are excited about the potential of this partnership.”

Mycrodose is one of only a handful of pharmaceutical companies that has been authorized by the United States Drug Enforcement Agency (“DEA”), State of California Attorney General’s Research Advisory Board, and The Food & Drug Administration (“FDA”) to import and research six (6) Schedule I, II and III compounds. In December 2021, Mycrodose added a Schedule I Import license which allows the import of Schedule I psilocybin and psilocin.
DEA import authorization gives Mycrodose the ability to import the controlled substance of psilocybin and psilocin for clinical trials, research and development, analytical purposes, and distribution to its clients for authorized research purposes.

“Our company’s proven ability to navigate the meticulous details required for approval by the DEA and FDA for these very difficult licenses has directly contributed to Mycrodose’s ability to lead the U.S.-Pharmaceutical sector working with these highly controlled-substances here in the United States,” says Chad Conner, Chief Executive Officer of Mycrodose Therapeutics. “This distribution partnership with HAVN Life increases access and the ease of obtaining GMP psilocybin for any U.S.-based research institution, university, or private biotech company working with this Schedule I compound. Mycrodose is dedicated to advancing research within this sector and this is one of many ways that we are helping,” he adds.

The interest and demand for psilocybin research in the United States has grown significantly in 2021 and continues to outpace supply in 2022. Recently the Drug Enforcement Agency (DEA) again increased the quota for psilocybin research in the U.S. HAVN and Mycrodose have already successfully completed a first purchase order and delivery of naturally derived GMP raw psilocybin mushrooms from Jamaica into the United States, and Mycrodose is actively handling new enquiries from approved DEA licensed institutions and research organizations.

HAVN Life’s operations in Jamaica are facilitated by strategic partnerships with Hypha Wellness and P.A. Benjamin Manufacturing Company to provide cultivation and processing facilities for psilocybe mushrooms.
For more information on obtaining naturally derived GMP psilocybin contact Mycrodose Therapeutics at www.MycrodoseThera.com

###
On Behalf of The Board of Directors
Tim Moore
Chief Executive Officer

About HAVN Life Sciences Inc.
HAVN Life Sciences is a biotechnology company pursuing standardized extraction of psychedelic compounds for investigational research as potential APIs, the development of natural health products, and innovative therapies to support brain health and enhance the capabilities of the mind.

Through its research division, HAVN Labs, the company has developed an end-to-end supply chain of standardized, naturally derived psychedelic compounds for investigational research in an effort to define the future of modern medicine. HAVN Life offers a full range of high-quality mushroom and plant extracts that help support immune function and support a healthy lifestyle.

Purchase our plant-based Natural Health Products and find out more at yourhavnlife.com, and follow us on FacebookTwitterInstagram and Youtube.

About Mycrodose Therapeutics
Mycrodose Therapeutics Inc. is a U.S.-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I-III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

Contact:

Investor Relations: ir@havnlife.com 604 687-7130
Media: savi@emergence-creative.com 647 896-8078

Forward-Looking Information: This news release contains “forward-looking information” within the meaning of applicable securities laws relating to statements regarding the Exclusive Distribution Agreement, Mycrodose’s business, products and future of Mycrodose’s business and the Company’s business, products and future of the Company’s business. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking information. Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance and developments to differ materially from those contemplated by these statements depending on, among other things, the risks that the anticipated benefits from the Exclusive Distribution Agreement will not be realized as contemplated, or at all, risks that Mycrodose’s products and plan will vary from those stated in this news release and Mycrodose may not be able to carry out its business plans as expected and risks that the Company’s products and plan will vary from those stated in this news release and the Company may not be able to carry out its business plans as expected. Except as required by law, the Company expressly disclaims any obligation and does not intend to update any forward-looking statements or forward-looking information in this news release. Although the Company believes that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. The statements in this news release are made as of the date of this release.

The CSE has not reviewed, approved or disapproved the content of this press release.LinkedInFacebookTwitterEmailShare

Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics Receives DEA License to Research Four Psychedelics

Mycrodose Therapeutics is pleased to announce that the company has been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds at their San Diego, California laboratory.

The company’s Schedule I DEA License was granted final approval after the DEA conducted an extensive in-person audit of Mycrodose Therapeutics’ facilities and after the FDA conducted an extensive review of the company’s in-depth research protocols for using Psilocybin, LSD, MDMA, and DMT in the development of their IP protected drug delivery technologies.

Mycrodose Therapeutics is one of a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds by the United States Drug Enforcement Agency (DEA).

“With the approval to research four Schedule I active pharmaceutics ingredients in our laboratory, we are extremely excited to marry those substances with our proprietary advanced drug delivery technologies. We are confident that our non-conventional drug delivery platforms will not only make the use of psychedelic drugs much safer but also increase the number of patients that can be treated with these powerful APIs. I’m thinking here in particular about children and the elderly. Due to the projected tight dosage control and the convenience of use, we are poised to elevate the status quo of psychedelic drug use in many medical conditions”, says Dr. Kochinke, Mycrodose Therapeutics, Chief Science Officer.

Dr. Frank Kochinke has over 30 years of experience inventing advanced drug delivery technologies and working with Schedule I compounds within the pharmaceutical-biotech industry. Having this in-house core expertise allowed Mycrodose Therapeutics to apply directly to the DEA, whereas many companies in the Psychedelic sector rely on the experience of third-party research institutions or Universities to carry out their research protocols.

Mycrodose Therapeutics laboratory in San Diego is currently in development of two (2) of their four (4) core technologies; the transdermal patch and transmucosal lozenge. The company’s IP Protected technology delivers a sustained and controlled dose of medicine into the body over time, which is believed to be safer and more effective than conventional drug delivery methods.

“We are excited to have a team with the expertise to obtain our Schedule I DEA license without needing to partner with a research institution or University. This milestone continues to validate the depth of our team, our research protocols, and our technologies,” says Chad Conner, Chief Executive Officer.

About Mycrodose Therapeutics:
Mycrodose Therapeutics (http://www.MycrodoseThera.com) is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License to research four (4) psychedelic compounds: Psilocybin, MDMA, DMT & LSD by the United States Drug Enforcement Agency (DEA).

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom
Chief Operating Officer
Mycrodose Therapeutics
Email: mailto:Patrick@MycrodoseThera.com [Patrick@MycrodoseThera.com __title__ null]
Phone: 1-619-494-1367
Website: http://www.MycrodoseThera.com

New microdosing patch for autistic patients

Nova Mentis and Mycrodose Therapeutics Announce Major Milestone with Transdermal Technology for Fragile X Syndrome Clinical Program

Nova Mentis (NOVA) and Mycrodose Therapeutics successfully created a transdermal patch that delivers Nova’s psilocybin formulation through the skin. The companies aim to use the patch to administer microdoses to autistic patients to treat cognitive impairments.

This method could be administered at home to reduce medical costs for families and save time for overworked medical professionals.

PDF of article

Novamentis

Congrats to the top psychedelics companies of 2021!

The 1st Annual Microdose Awards

These leading companies were recognized for their accomplishments at Microdose Psychedelic Insights’ Wonderland: Miami – the world’s largest psychedelic business event ever.

Company of the Year: Cybin Inc. (CYBN)

Psilocybin Company of the Year: MycroDose Therapeutics (private)

Ketamine Company of the Year: Field Trip Health (FTRP)

Ibogaine Company of the Year: MindMed (MNMD)

DMT Company of the Year: Psilera Bioscience (private)

LSD Company of the Year: MindMed (MNMD)

MDMA Company of the Year: MAPS (non-profit)

Platform Company of the Year: MindMed (MNMD)

Drug Development Company of the Year: Awakn Life Sciences (AWKN)

Retreat of the Year: Synthesis

Clinic of the Year: Awakn Life Sciences (AWKN)

B2C Tech Company of the Year: Fireside Project (non-profit)

B2B Tech Company of the Year: MycroDose Therapeutics (private)

PDF of article

Mycrodose Therapeutics and Nova Mentis Announce LOI to Co-Develop Advanced Drug Delivery System

Mycrodose Therapeutics and Nova Mentis Announce LOI to Co-Develop Advanced Drug Delivery System

Partnership will Create Patented Products for the Treatment of Neuroinflammatory Disorders

October 19, 2021 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders, and Mycrodose Therapeutics (“Mycrodose”), a US pharmaceutical company focused on developing advanced drug delivery systems for use with psychedelic compounds, announce that they have entered into a letter of intent (“LOI”) to develop patented products to treat neuroinflammatory disorders, such as fragile X syndrome (“FXS”) and autism spectrum disorder (“ASD”).

The Joint Venture (“NewCo”) will accelerate the research and development of psilocybin-based therapeutics by utilizing Mycrodose Therapeutics’ patented advanced drug delivery systems with Nova’s proprietary psilocybin drug to treat patients with neuroinflammatory conditions, including FXS, the most common inherited cause of ASD.

“NOVA’s lead drug candidate, psilocybin, has revealed significant promising results in preclinical models of fragile X syndrome and autism spectrum disorder. The results are exciting and have shown that psilocybin corrects the cognitive deficits displayed by a rat model of FXS and mitigates the anxiety-like traits observed in an environmental model of autism based on prenatal exposure to valproic acid,” stated Marvin S. Hausman MD,  Chairman of NOVA’s Scientific Advisory Board. “We have established a microdose therapeutic level for psilocybin in our most recent study that can be used in a planned upcoming human clinical study. This collaboration with Mycrodose Therapeutics is a ‘hand and glove fit’ with our breakthrough psilocybin microdose discovery, as their advanced drug delivery technologies offer many advantages for microdosing drug delivery, including providing a non-invasive, sustained and controlled dose of medicine that can be self-administered.”

NOVA has already successfully completed four preclinical studies confirming the therapeutic efficacy of the company’s proprietary psilocybin drug. The ability of the drug to modulate levels of neuroinflammatory molecules (cytokines) measured pre- and post-treatment is an important catalyst driving the fragile X clinical program.

“With the high safety profile of Mycrodose’s technologies and NOVA’s FDA/EU FXS orphan drug indication for its proprietary psilocybin, this partnership opens microdosing psilocybin-based drugs to a broader patient base, including pediatric applications. To our knowledge, the planned therapeutic study for autism and fragile X will be the first to research the potential for psilocybin to help treat pediatric patients,” says Chad Conner, Chief Executive Officer, Mycrodose Therapeutics. “The complementary relationship between NOVA and Mycrodose definitely helps everyone get into clinical trials faster with fewer hurdles. The sum of this partnership with NOVA is much greater together than each individual company alone, and allows our combined team to deepen its research on our kids and young people, a segment of the population that truly touches all of our hearts.”

NOVA has applied to the US FDA and European Union for psilocybin Orphan Drug designation for fragile X syndrome treatment, which would provide a wide range of financial and regulatory benefits.

The US Orphan Drug Act grants very attractive financial incentives to companies through a seven-year period of market exclusivity for the drug approved, even if the product is not under a provisional or granted patent. In addition, the US Orphan Drug Act provides tax credits of up to 50% of the qualified clinical testing expenses, provides grants for clinical testing, additional assistance in framing protocols for investigations, and the FDA waives the $2.4 million New Drug Application filing fee.

Summary Terms of the LOI include:

  • The Parties will incorporate a company (“NewCo“) whereby both Nova Mentis and Mycrodose Therapeutics will subscribe for shares to become equal 50% shareholders of NewCo and nominate an equal number of individuals to the Board of Directors of NewCo.
  • NewCo will be the owner of the Product(s), technologies, R&D protocols, and data gathered.
  • The Parties will mutually develop a R&D and Clinical Plan.
  • Mycrodose Therapeutics will give an exclusive license of its patented technologies to the collaboration for agreed upon indications.
  • A Scientific Advisory Board (“SAB”) will be created by the Parties to decide priorities based on rationales (financial, medical, clinical, scientific, delivery, etc.) that ranks the importance of specific product development and applicable clinical programs. The formalization of a definitive agreement is subject to satisfactory due diligence from both parties as well as other conditions customary for such a transaction.

About Mycrodose Therapeutics

Mycrodose Therapeutics is a US-Based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing psychedelic compounds to treat mental health and cognitive degenerative diseases. Mycrodose is one of only a few private companies that has been granted a Schedule I License and been approved by the United States Drug Enforcement Agency (DEA), State of California Attorney General’s Research Advisory Board, and The US Food & Drug Administration (FDA) to research four (4) psychedelic compounds: psilocybin, LSD, MDMA, and DMT. The company believes that its IP-Protected Sustained Microdosing Technology is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom

Chief Operating Officer

Mycrodose Therapeutics

Email: Patrick@MycrodoseThera.com

Phone: 1-619-494-1367

Website: www.MycrodoseThera.com

 

About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. The goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and Fragile X Syndrome (FXS).

For further information on the Company, please

visit https://www.novamentis.ca or email info@novamentis.ca

On Behalf of the Board

Will Rascan, President & CEO

Nova Mentis Life Science Corp.

Phone: 778-819-0244

Toll Free: 1-833-542-5323

Twitter: @novamentislsc

Instagram: @novamentislsc

Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

 This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

Autistic children try microdosing

Mycrodose Therapeutics and Nova Mentis Announce LOI to Co-Develop Advanced Drug Delivery System

According to preclinical research conducted by Nova Mentis (NOVA), psilocybin has potential to reduce anxiety in autistic patients and could improve cognitive function in patients with fragile x syndrome (FXS), a genetic condition that causes learning impairments.

Now, the company is forming a joint venture with Mycrodose Therapeutics to accelerate R&D into the treatment. The partnership will use Mycrodose Therapeutics’ patented systems to self-administer a non-invasive microdose.

The joint venture plans to conduct human clinical trials on a broad range of patients with FXS and autism spectrum disorder (ASD), including pediatric patients. This will be the first study investigating psilocybin’s impact on children.

PDF of article