NEW YORK, Nov. 08, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, today released its third quarter pipeline update.
“Seelos continued to make significant progress in the third quarter on several of our programs”, said Raj Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics. “We expect screening and dosing to commence in the phase IIb/III trial in Sanfilippo syndrome in the US for SLS-005, and in the PK/PD/DDI studies for SLS-002. As a result, we envision multiple clinical studies in these two programs next year. Getting these studies launched in consultation with the FDA, completing a financing, and ringing the opening bell at Nasdaq have kept us very busy and has continued to raise awareness of our company.”
“IND enabling work has also begun in SLS-008,” added Tim Whitaker, MD, Head of R&D. “We plan to study SLS-008 in a pediatric orphan indication, and we are exploring other potential target indications as well.”
Third Quarter Corporate Highlights
- Seelos received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for Seelos' U.S. Patent Application for SLS-005 (trehalose) for treating Friedreich Ataxia (FA).
- The company received a grant from Team Sanfilippo Foundation for funding of studies of SLS-005 in Sanfilippo syndrome type A and B patients and the separate expanded access study for Sanfilippo type C and D as well as type A and B patients who do not meet the trial entry criteria.
- Seelos announced the Investigational New Drug Submission and Acceptance from FDA for SLS-005 for Mucopolysaccharidosis type III (Sanfilippo syndrome).
- The Seelos staff and board of directors rang the opening bell at the Nasdaq Marketsite in Times Square on August 12th.
- The company raised $6.7 million in a registered direct offering with certain institutional investors.
Update on Pipeline Development
- Seelos is initiating its Phase I studies to further evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) of SLS-002 (intranasal racemic ketamine) in healthy volunteers this quarter and preliminary data from such studies are expected in Q1 2020.
- Seelos amended its agreement with Vyera Pharmaceuticals which removes the requirement to conduct a Phase III trial for SLS-002 and converts the one-time cash payment obligation otherwise owed to Vyera for commencement of the Phase III trial to a series a cash and stock payments over the next 9 months.
- The company completed a Type C meeting (face to face) with the FDA to discuss the potential design of a Proof of Concept (PoC) study for SLS-002. Based on feedback from its Type C meeting with FDA, Seelos plans to conduct a Phase II PoC study in patients with Major Depressive Disorder (MDD) at Imminent Risk of Suicide.
- The company is seeking scientific advice from EMA to initiate a clinical study in Sanfilippo syndrome patients in EU.
- Seelos began IND enabling work this quarter on SLS-008 which it plans to develop for pediatric esophagitis, an orphan disease and is exploring other potential target indications.
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 our expectations regarding the expected timing for dosing the first patient with Sanfilippo Syndrome with trehalose, expectations regarding the initiation of a phase I study with intranasal racemic ketamine in Suicidality-PTSD, expectations regarding the timeline for receiving preliminary data from the company’s phase I studies, plans regarding the study of SLS-008 in a pediatric orphan indication and expectations regarding proof of concept for target engagement for peptide-based approach targeting the NACore in Parkinson's Disease. These statements are based on the company's 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 to 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 our product candidates, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund our development plans and ongoing operations, 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.
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022