Seelos Therapeutics Inc. (NASDAQ: SEEL) is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The company’s portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Among the conditions targeted are Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson’s disease, other psychiatric and movement disorders and orphan diseases.
Seelos Therapeutics has two assets in human trials, SLS-002 targeting ASIB-MDD, and SLS-005 targeting ALS, also known as Lou Gehrig’s disease. Part 1 of a proof-of-concept study of SLS-002 was released in May 2021, and part 2 will be released early in 2022. SLS-005 does not have clinical data yet.
The company’s strategy focuses on advancing multiple late-stage therapeutic candidates for CNS disorders, developing therapeutics with proven mechanisms of action and identifying opportunities in large markets. In the Seelos Therapeutics business model, assets must serve a large unmet medical need, orphan population or a unique approach to existing treatments. Assets also must possess extensive scientific rationale and/or existing human data. Seelos Therapeutics looks for assets that are clinically ready or need minimal pre-clinical work. In addition, the clinical development pathway should make economic sense and be appropriate for a company the size of Seelos Therapeutics. The company is headquartered in New York.
Seelos Therapeutics’ SLS-002 (intranasal ketamine) aims to treat ASIB in Major Depressive Disorder and Post-Traumatic Stress Disorder. The company believes SLS-002 has the potential to transform the treatment of ASIB in those disorders. Current treatments include hospitalization and/or anti-depressants, many with warnings because they can lead to increase in suicidal thoughts. Most anti-depressants are slow acting, working over a period of weeks. Ketamine has been shown to work within hours. In addition, the nasal spray system is easily administered, non-invasive and convenient.
Seelos Therapeutics recently entered an exclusive agreement to acquire the worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd. for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™. The company plans to evaluate the sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including PTSD.
The FDA has accepted Seelos’ Investigational New Drug (IND) application to study SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion) for the treatment of spinocerebellar ataxia (SCA). The FDA has also granted the program Fast Track designation in the U.S. for SCA. SLS-005 has previously received Orphan Drug designation for spinocerebellar ataxia type 3 (SCA3) from the FDA and from the European Medicines Agency in the EU. SCA is a highly debilitating neurodegenerative disease that currently lacks a cure or an approved therapeutic and, as such, patients manage symptoms through physical therapy and other symptomatic treatments.
The company received an issued patent from the Japanese Patent Office (Japanese patent number 6968839, titled: STRUCTURE-BASED PEPTIDE INHIBITORS OF ALPHA-SYNUCLEIN AGGREGATION), covering the composition of matter for SLS-007, a potentially disease-modifying gene therapy focused on intracellular alpha-synuclein (α-synuclein) aggregation in Parkinson’s disease. Seelos Therapeutics is currently conducting in vivo preclinical studies on SLS-007 for patients with Parkinson’s disease. The preclinical studies are designed to establish the in vivo pharmacokinetic and pharmacodynamic profiles and target engagement parameters of SLS-007. The company was issued a composition of matter patent for SLS-007 in the U.S. in October 2020.
Worldwide, more than 800,000 people die by suicide annually. Suicide is the 10th leading cause of death in the U.S. every year, claiming 45,000 lives – on average one every 12 minutes. Depression is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide, affecting an estimated 300 million people globally. Approximately one-third of patients with MDD are diagnosed with treatment-resistant depression. The World Health Organization says MDD will be a leading cause of disability by 2030. Depression affects nearly 1-in-4 Americans aged 18 and over in any given year.
According to a report from ResearchAndMarkets, the global psychedelic drugs market is expected to grow from $3.21 billion in 2021 to a value of $6.33 billion in 2026, a CAGR of 14.5% during the forecast period. Market growth is due to a large unmet need for mental health treatment driving the adoption of psychedelic drugs. North America accounts for half of the revenue in the global psychedelic drugs market and should be worth $3.184 billion by the end of the forecast period.
The senior leadership team members at Seelos Therapeutics are passionate, empowered, experienced, and committed to building a responsibly driven company focused on the most efficient development of products that address significant unmet needs in CNS disorders and in rare diseases.
Raj Mehra, PhD, is the chairman, founder, and CEO at Seelos Therapeutics. He has 23 years’ experience as a venture capitalist and investor.
Michael Golembiewski is CFO at Seelos Therapeutics. He has 28 years of experience in public company accounting and finance.
Tim Whitaker, M.D., is Chief Medical Officer at Seelos Therapeutics. He has 24 years of experience with 19 new drug applications (NDA) and supplemental new drug applications (sNDAs) approved in CNS.
Warren Wasiewski, M.D., is Senior Neuro Advisor at Seelos Therapeutics. He has 23 years of experience as a pediatric neurologist, 18 years in the pharmaceutical industry, and has designed clinical trials for five orphan CNS programs.
Jessica Kardish is Head of Clinical Operations at Seelos Therapeutics. She has 26 years of experience with five NDAs in CNS and rare diseases.
Gopal Krishna, Ph.D., is the Head of Manufacturing and Technical Operations at Seelos Therapeutics. He has 27 years of experience in cGMP, GLP, and CMC regulations.
Anthony Marciano is the Chief Communications Officer at Seelos Therapeutics. He has 25 years of experience in health care investor engagement.
- Seelos Therapeutics received a patent from the Japanese Patent Office covering its SLS-007 for Parkinson’s disease.
- The company was issued a similar patent for SLS-007 in the U.S. in October 2020.
- Seelos Therapeutics has an exclusive worldwide license agreement, excluding China, for Wafermine™, a sublingual ketamine wafer.
- The U.S. Food and Drug Administration has accepted Seelos’ Investigational New Drug application to study SLS-005 for treatment of spinocerebellar ataxia (SCA).