Chicago, IL and Toronto, ON (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 following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the Company is expanding its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) and exploring other complementary orphan indications.
Consistent with the positive feedback received from FDA, Wesana will accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the prior development pathway for SANA-013 with TBI associated depression as the lead indication, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.
Wesana’s SANA-013 is designed to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). The low, non-hallucinogenic dose of psilocybin in combination with CBD is being developed for MDD and other indications so that affected people can benefit from a chronic, at-home use proposition.
Daniel Carcillo, Wesana’s founder and Chief Executive Officer, said, “Given the positive written feedback from FDA regarding SANA-013, we are extremely excited to begin developing meaningful clinical data for our novel formulation and protocol. We believe SANA-013 provides Wesana distinct advantages compared to other companies exploring psilocybin, as they are primarily focused on delivering large in-clinic doses of psilocybin on an intermittent basis and therefore are not optimally positioned to treat conditions such as MDD that likely will require some kind of chronic dosing.”
MDD is a chronic, recurring, and debilitating mental disorder leading it to be one of the most burdensome illnesses on a global scale. Patients suffering from MDD are frequently and significantly impaired from an occupational and social function standpoint resulting in severe economic costs. With approximately 264 million people suffering from depression globally, according to World Health Organization data in 2020, the market size is currently estimated to grow at a CAGR of 3.9% to US$16 billion by 2026.1
About Wesana Health
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the Company’s future operations and clinical trials, including initiation of a Phase 1b/2a study for MDD in H1 2023. as part of a revised accelerated development pathway; and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
Certain assumptions that influence the successful initiation of a Phase 1b/2a study for MDD in H1 2023 as part of an expanded development pathway include: (i) the Company’s capital will be sufficient to execute the expanded (or any) development pathway; (ii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broadened indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance as to the Company’s ability to raise additional funding to finance its operations; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; general economic, market and business conditions and other risk factors including those found in the Company’s management’s discussion and analysis for the year ended December 31, 2021 and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
1 Source: 2020, October. “Depression Treatment Market By Drug Type (Antidepressants, Antipsychotics) By Application (Major Depressive Disorder (MDD), Bipolar Disorder), By End-User (Hospitals, NGOs, Mental Health Centers), By Distribution Channel, and By Region, Forecasts to 2027.” Emergen Research,