Seelos Therapeutics Announces Year End 2020 Business Update

Rhea-AI Summary

Seelos Therapeutics (Nasdaq: SEEL) reported significant advancements in its year-end 2020 update. The company completed its safety trial for the intranasal ketamine program and initiated pivotal trials for major depressive disorder. They achieved key milestones for their ALS and Parkinson's disease programs, receiving orphan drug designations and entering the HEALEY ALS Platform Trial at Harvard. Seelos expanded its team with experienced industry professionals, enhancing its operational capacity. The company anticipates upcoming clinical studies in suicidality and ALS in 2021.

Positive

• Completion of safety trial for intranasal ketamine program.
• Initiation of pivotal trial for major depressive disorder.
• Acceptance of trehalose program into HEALEY ALS Platform Trial at Harvard.
• Receiving orphan drug designations in the US and Europe for various programs.
• Expansion of the Seelos team with experienced professionals.

Negative

• None.

NEW YORK, Jan. 6, 2021 /PRNewswire/ -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year end 2020 business update.

"This past year marked the most significant 12 months in Seelos Therapeutics' history despite being an otherwise challenging year due to the COVID-19 pandemic.  We completed our safety trial for the intranasal ketamine program and began opening centers for our pivotal trial for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. The trehalose program's pivotal study in ALS was accepted into the HEALEY ALS Platform Trial at Harvard and we began our first in vivo studies of SLS-004 and SLS-007, our gene therapy Parkinson's programs. Seelos received additional patents around the world, orphan drug designations in the US and Europe for various programs plus a Rare Pediatric Disease Designation for SLS-005," remarked Raj Mehra Ph.D., Chairman and CEO of Seelos. "We look forward to 2021 as we embark on clinical studies in two unmet needs, namely imminent suicidality and ALS. We have expanded the Seelos team by adding several experienced industry veterans as full-time Seelos employees to efficiently execute clinical and preclinical programs."  

Seelos Team Update

Over the past six months, Seelos expanded its team with the hiring of four full-time employees and the addition of a consultant to aid in the development of key programs.

In addition, Tim Whitaker, MD will now serve as Chief Medical Officer (CMO) for Seelos, formerly serving as Head of Research and Development, and Warren W. Wasiewski, M.D., F.A.A.P. will now serve as Senior Neuro Advisor.

Jessica Kardish, Kimberly Farrand, Lucas Pilipski and Manira Rayamajhi, have all accepted full-time positions at Seelos as follows:

• Jessica Kardish joined Seelos in January 2021 as Seelos' VP, Clinical Development and Operations. Ms. Kardish has over 25 years of drug development and operations experience in mid-size and small pharma companies, primarily in CNS and rare disease spaces. During her 11 years at Shire Pharmaceuticals, Ms. Kardish had a successful track record which included five global regulatory approvals. She holds a Bachelor of Science from Dickinson College and a Master's in Public Health from The Johns Hopkins University.  
• Kimberly Farrand joined Seelos in July 2020 as Seelos' Senior Director, Clinical Development and Operations. Ms. Farrand possesses over 20 years of experience in the industry and spent over 17 years at Shire Pharmaceuticals prior to its acquisition by Takeda Pharmaceutical Company. She holds a Bachelor of Science in Chemistry from Penn State and a Master's in Public Health in Epidemiology from The George Washington University.
• Lucas Pilipski joined Seelos in December 2020 as Seelos' Executive Director of Clinical Operations. Mr. Pilipski has over 17 years of industry experience and spent over four years at Sanofi S.A. and eight years at Shire Pharmaceuticals. He holds a Bachelor of Science in Biology from William Patterson University and a Master's of Science in Biology from Villanova University.
• Manira Rayamajhi, Ph.D.,  joined Seelos in July 2020 as Seelos' Associate Director, Global Regulatory Affairs. She has 10 years of experience spanning multiple therapeutic areas and in all phases of development. She was a Postdoctoral Research Fellow at the University of North Carolina at Chapel Hill for 5 years and previously worked at Carmago Pharmaceutical Services, Syneos Health, and MMS Holdings in various capacities. Dr. Rayamajhi holds a Bachelor of Arts in Biology and Chemistry from Wesleyan College and a Ph.D. in Immunology from the University of Colorado Denver.

David M. Biondi, DO, FAAN has also joined Seelos as a consultant with an extensive background in medical practices and the pharmaceutical industry. Dr. Biondi served as a neurologist in the United States Navy and later in community and academic practice settings. He held medical affairs and clinical development roles at Janssen Pharmaceuticals, Johnson & Johnson, and Alder Biopharmaceuticals. He most recently served as Executive Director for Clinical Programs at Cohen Veterans Bioscience and currently sits on their Board of Directors. Dr. Biondi holds a Bachelor of Science in Pharmacy from Long Island University, a Doctor of Osteopathic Medicine from The University of New England and served his Neurology Residency at the US National Naval Medical Center in Bethesda, MD.

Seelos Business Update

In 2020, Seelos Therapeutics achieved several major milestones and continued to make progress on its multiple clinical stage development programs.

SLS-002 (intranasal racemic ketamine)

• In March, completed a Type C meeting with the FDA for advice on a regulatory pathway and two-part pivotal trial design 
• In the second quarter, released final safety data of Phase I pharmacokinetics/pharmacodynamics study showing a safe and well tolerated side effect profile at the highest dose levels 
• In the fourth quarter, initiated trial sites in screening and dosing patients for the open-label 16 patient Part A study  
• Received a new patent in Japan for anxiety due to phobic disorders 

SLS-005 (IV trehalose)

• In the third quarter, received a "may proceed" notice from FDA to initiate pivotal Phase IIb/III trial in ALS
• In December, SLS-005 was selected for the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital 
• SLS-005 received US Orphan Drug Designation (ODD) in ALS and Sanfilippo syndrome and European ODD for Sanfilippo syndrome 
• Granted Rare Pediatric Disease Designation for SLS-005 in Sanfilippo syndrome
• Received multiple patents in US and Israel

SLS-004 and SLS-007 (Parkinson's disease gene therapy programs)

• In the second quarter, initiated preclinical in vivo studies of both SLS-004 and SLS-007 in Parkinson's disease
• In September, announced a sponsored research agreement with Duke University for gene therapy studies of SLS-004 
• In October, received a patent covering composition of matter for SLS-007  

Upcoming Catalysts

SLS-002 (intranasal racemic ketamine)

• Potentially pivotal Proof of Concept study commenced in December, and Seelos is continuing to open trial sites for screening and dosing
• First data readout upon completion of the first 16 patients in the Part A open-label portion

SLS-005 (IV trehalose)

• Pivotal Phase IIb/III trial in ALS to begin in the first half of 2021 in the HEALEY ALS Platform Trial

SLS-004 and SLS-007 (Parkinson's disease gene therapy programs)

• SLS-007 Preclinical data on delivery and target engagement expected in Q1 2021
• SLS-004 Preclinical data expected mid-2021

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding Seelos' ability to complete clinical studies for product candidates for imminent suicidality and ALS, Seelos' ability to efficiently execute clinical and pre-clinical programs, the hiring of certain employees and consultants, including their ability to aid in the development of key programs, the safety profile of SLS-002, the final safety data of SLS-002, the potential pivotal proof of concept study for SLS-002, opening additional trial sites for screening and dosing for the pivotal proof of concept study for SLS-002, the commencement of the pivotal Phase IIb/III trial of SLS-005 for ALS in the HEALEY ALS Platform Trial, the expected timing for preclinical data regarding the delivery and target engagement of SLS-007, and the expected timing for preclinical data for SLS-004. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

 

View original content to download multimedia:http://www.prnewswire.com/news-releases/seelos-therapeutics-announces-year-end-2020-business-update-301201900.html

SOURCE Seelos Therapeutics, Inc.

FAQ

What were the major accomplishments of Seelos Therapeutics in 2020?

Seelos completed the safety trial for its intranasal ketamine program, initiated pivotal trials for major depressive disorder, and achieved key milestones in ALS and Parkinson's disease programs.

What programs did Seelos Therapeutics receive orphan drug designations for?

Seelos received orphan drug designations for its trehalose program in ALS and Sanfilippo syndrome, as well as for other programs in Europe and the US.

What is the significance of the HEALEY ALS Platform Trial for Seelos Therapeutics?

The acceptance of Seelos' trehalose program into the HEALEY ALS Platform Trial at Harvard is a significant milestone indicating progress in ALS treatment research.

What clinical studies is Seelos Therapeutics planning for 2021?

Seelos is planning to commence clinical studies for imminent suicidality and ALS in 2021.

How did Seelos Therapeutics expand its team in 2020?

Seelos expanded its team by hiring four full-time employees and a consultant with extensive industry experience.