Jaguar Health and Filament Health Sign Letter of Intent to Develop Botanical Prescription Drugs for Specific Mental Health Indications

Drug Discovery Collaboration Will Leverage the Botanical Drug Development Expertise of Both Companies

SAN FRANCISCO, CA / ACCESSWIRE / June 9, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) and Filament Health Corp. (NEO:FH) today announced that the companies have signed a letter of intent to enter a collaboration agreement to develop botanical prescription drugs for specific psychoactive target indications in the United States. The goal of the collaboration is to extend the botanical drug development skillsets of both companies in order to develop pharmaceutical-grade, standardized drug candidates and partner with a potential future licensee regarding the development and commercialization of these novel plant-based drugs for indications such as attention-deficit/hyperactivity disorder (ADHD) and social anxiety disorder.

“We are thrilled with this collaboration with Filament Health, a company focused on discovering, developing and standardizing botanical drugs as well as the delivery to patients suffering from mental health conditions,” said Steven King, PhD, Jaguar’s Chief Sustainable Supply, Ethnobotanical Research & IP Officer and head of the company’s Entheogen Therapeutics Initiative (ETI). Jaguar’s ETI aims to discover and develop groundbreaking, novel, natural medicines derived from psychedelic and psychoactive plants for treatment of mood disorders, neurodegenerative diseases, addiction, and mental health disorders. “Jaguar and Filament are in the process of identifying plant candidates that may prove beneficial for addressing indications such as ADHD and social anxiety disorder, for which we plan to collaboratively work to develop botanical drugs.”

“Filament is a leader in the development of botanical medicines, and we are dedicated to supporting the treatment of mental health conditions through our expertise and technology,” said Benjamin Lightburn, Chief Executive Officer of Filament Health. “We have developed novel manufacturing and standardization techniques which we have applied to psilocybin, psilocin and ayahuasca. We are pleased to partner with Jaguar and look forward to working with their team to identify and standardize new entheogens.”

Under this partnership, Jaguar will have responsibility for the identification of plants that may offer novel mechanisms of action, as well as for botanical drug development and the raw material supply chain. Filament will be responsible for developing the manufacturing techniques required to produce standardized, pharmaceutical-grade drug candidates. The two companies will then jointly seek partnership with a potential licensee for full development and commercialization of novel drug candidates, with proceeds from the relationship split equally between Jaguar and Filament.

“We very much look forward to working with Filament on this initiative,” said Lisa Conte, Jaguar’s President, CEO and Founder. “Jaguar’s core team began focusing more than 30 years ago on the development and commercialization of plant-based prescription medicines, and our Mytesi^® (crofelemer) product, approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy, is the only oral plant-based prescription medicine approved under FDA Botanical Guidance. Filament’s expertise in natural product chemistry and drug development allows for the mobilization of a key asset we have generated over 30 years – a library of 2,300 medicinal plants and 3,500 plant extracts, all from firsthand ethnobotanical investigation by Jaguar and our ETI Scientific Strategy Team (SST).”

The ETI SST will support this collaboration, and consists of leading and globally renowned ethnobotanists, physicians, and pharmacologists, as well as experts in the fields of natural product chemistry and neuropharmacology:

• Michael J. Balick, Ph.D.: Considered one of the world’s leading ethnobotanists and economic botanists; specialist in healing plants and toxic plants and their use by Indigenous peoples; research associate of the Brain Chemistry Labs of the Institute of EthnoMedicine; member of original scientific strategy team that contributed to development of Jaguar’s plant library.
• Thomas Carlson, M.D., M.S.: Ethnobotanist, botanist, physician; teaching professor of integrative biology at the University of California, Berkeley; member of original scientific strategy team that contributed to development of Jaguar’s plant library; key architect of ethnomedical field research process conducted by ethnobotanist/physician teams of Jaguar predecessor company Shaman Pharmaceuticals.
• Pravin Chaturvedi, Ph.D.: Pharmacologist with specialty in neuropharmacology; chair of the Scientific Advisory Board of Napo Pharmaceuticals (Napo), Jaguar’s wholly-owned subsidiary, and the chief scientific officer of Jaguar; Over 25+ year career, led discovery and/or development activities for several new chemical entities including development of Napo’s FDA-approved drug product, Mytesi^® (crofelemer), the only oral plant-based prescription medicine approved under FDA Botanical Guidance.
• Julie Anne Chinnock, ND, MPH, ARNP/CRNA: Ethnobotanist; Doctor of Naturopathic Medicine; owner and manager of Ketamine clinic; part of original Shaman Pharmaceuticals field research teams; public health expert.
• Stephen Dahmer, M.D.: Ethnomedical researcher and practicing integrative physician; expert on endocannabinoids who has conducted ethnomedical field research in tropical regions.
• Wade Davis, Ph.D.: Ethnobotanist, anthropologist, writer, and professor of anthropology at University of British Columbia; extensive international ethnobotanical field research.
• Elaine Elisabetsky, Ph.D.: Among world’s leading ethnopharmacologists; professor in the pharmacology and biochemistry departments of the Universidade Federal do Rio Grande do Sul in Brazil; member of original scientific strategy team that contributed to development of Jaguar’s plant library.
• Nigel Gericke, M.B.B.Ch.: Medical doctor, ethnobotanist, and ethnopharmacologist; former advisory panelist to the United States Pharmacopoeia; longstanding member of the Medicinal Plants Specialist Group of the World Wide Fund For Nature; founding member of the Association for African Medicinal Plants Standards.
• Maurice Iwu, Ph.D.: President of Bioresources Development Group and founder of International Center for Ethnomedicine and Drug Development (InterCEDD) in Nigeria; member of original scientific strategy team that contributed to development of Jaguar’s plant library.
• Steven R. King, Ph.D.: Ethnobotanist; Napo’s chief sustainable supply and ethnobotanical research officer; managed Napo’s original scientific strategy team and outcomes; research associate of the Brain Chemistry Labs of the Institute of EthnoMedicine.
• Charles Limbach, M.D.: Ethnomedical specialist and family medicine physician; member of original scientific strategy team that contributed to development of Jaguar’s plant library.
• David Sesin, Ph.D.: Natural product chemist; Jaguar’s chief manufacturing officer; created isolation and manufacturing process for Mytesi (crofelemer).

About Filament Health

Filament Health (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) is a clinical-stage natural psychedelic drug development company. Filament believes that safe, standardized, naturally-derived botanical medicines can improve the lives of many, with a mission to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural medicines, including psychedelic medicines, for clinical development. Filament is paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn

About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals, & Napo Therapeutics

Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Animal Health is a tradename of Jaguar Health. Jaguar Health’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe.

For more information about Jaguar Health, please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com.

About Mytesi^®

Mytesi (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).

See full Prescribing Information at Mytesi.com. Crofelemer, the active ingredient in Mytesi, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon Rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that the collaboration between Jaguar and Filament will identify plant candidates that may prove beneficial for addressing indications such as ADHD and social anxiety disorder, and the expectation that this collaboration will identify and standardize new entheogens. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:

Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

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