Wesana Health Granted US FDA Pre-IND Meeting for SANA-013


Ryan Allway

January 11th, 2022

Psychedelics


CHICAGO and TORONTO, Jan. 11, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pleased to announce that the U.S Food and Drug Administration (U.S. FDA) granted the Company’s request for a pre-IND (Investigational New Drug) meeting to discuss the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD).

 

In the pre-IND meeting, the Company expects to receive feedback from the FDA on its toxicology program and research to-date, in advance of IND clearance and initiation of the Phase I clinical trial, currently anticipated to occur in late 2022.

 

“This is a thrilling milestone in my nearly-decade long effort to find and advocate for treatments that provide hope to brain injury survivors,” said Daniel Carcillo, Wesana founder and CEO. “People who are suffering with severe TBI-related depression have a fivefold increase in suicide attempts and are 3 to 4 times more likely to die by suicide1 2. They deserve to have the best diagnostics and treatment options available to them, including a pharmaceutical option that doesn’t exasperate symptomology. We look forward to being able to move SANA-013 to a Phase I clinical trial as soon as possible.”

 

While there are a number of available therapies to treat depression, the success rate of antidepressants is only approximately 30 to 40%, highlighting the need for additional therapeutic options3. Further, despite the established importance of treating depression, only 44% of TBI patients with Major Depressive Disorder (MDD) received antidepressants or counseling4. Of those treated, there is limited evidence supporting the efficacy of antidepressants in the treatment of post-TBI depression5.

 

Wesana’s drug development program looks to utilize combination therapy to treat migraine and the symptoms associated with TBI, such as depression. By utilizing psilocybin and cannabidiol (“CBD”), a combination therapy of compounds with demonstrated effectiveness, SANA-013, is targeted to improve neuroplasticity and neurogenesis while acting as an anti-neuroinflammatory. In contrast to therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects beginning as early as a few weeks post administration, SANA-013 utilizes a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.

 

Mark A. Wingertzahn, Wesana’s Chief Scientific Officer said, “The data generated, and progress across Wesana’s drug development portfolio continues to exceed our expectations. This upcoming year is going to be important for Wesana as we continue to move through our development program with SANA-013 and have additional discussions on the development strategy and importance of this therapy with regulators in the U.S. and abroad.”

 

Please refer to the Company’s management’s discussion and analysis dated November 29, 2021, available on the Company’s profile on www.sedar.com for additional information as to the Company’s drug development program and the steps required to be completed for the Company to be able to commence phase I clinical trials.

 

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and proprietary protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

 

________________________
1
 Juengst SB, Kumar RG, Wagner AK. A narrative literature review of depression following traumatic brain injury: prevalence, impact, and management challenges. Psychol Res Behav Manag. 2017;10:175-186.

 

2 Oquendo MA, Friedman JH, Grunebaum MF, Burke A, Silver JM, Mann JJ. Suicidal behavior and mild traumatic brain injury in major depression. J Nerv Ment Dis. 2004;192(6):430-4.

 

3 Eaton WW, PI A, Kessler RC. The population dynamics of mental disorders Eaton WW, ed Public Mental Health. Oxford University Press, 2012:125-150.

 

4 Bombardier CH, Fann JR, Temkin NR, Esselman PC, Barber J, Dikmen SS. Rates of major depressive disorder and clinical outcomes following traumatic brain injury. JAMA. 2010;303(19):1938-45.

5 Robert S. Traumatic brain injury and mood disorders. Ment Health Clin. 2020;10(6):335-345.

 

CONTACT: For more information, please contact: Investor Contact: Keenan Gentry Email: [email protected] Phone: 773-236-7972 Media Contacts: Nick Opich / Fallon Carter KCSA Strategic Communications Email: [email protected] Phone: 212-896-1206 On behalf of the Board of Directors: Daniel Carcillo, Chief Executive Officer Phone: 773-236-7972


This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


Network Partners

Follow Us on Social Media

About CFN Media Group

CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.

Disclaimer: Matters discussed on this website contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. CFN Media Group, which owns CannabisFN, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.

Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer

loading