NEW YORK, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced an update regarding its development programs for SLS-005 (trehalose) in Europe and the U.S.
Seelos has scheduled a meeting in March 2020 to meet with the European Medicines Agency (EMA) to seek scientific advice and protocol assistance for a European clinical study of SLS-005 in patients with Sanfillipo syndrome type A and B. The EMA provides support, including regulatory guidance and incentives, for the research and development of medicines for rare diseases in the European Union (EU).
“We are truly excited to be working with the EMA to formulate the Sanfilippo study in the EU”, said Raj Mehra, Ph.D., Chairman and CEO of Seelos, “there are currently no approved therapies in the EU for this devastating neurological condition.”
Additionally, Seelos has submitted to the FDA a protocol for its planned expanded access study for Sanfilippo syndrome type C and D patients as well as type A and B patients who do not meet the Phase IIb/III trial entry criteria.
Seelos continues to pursue its plans to develop SLS-005 in oculopharyngeal muscular dystrophy (OPMD) and is evaluating other potential indications where scientific rationale for studying trehalose exists.
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 the scheduled meeting with the EMA and any potential outcome of such meeting, the potential for an expanded access study for Sanfilippo syndrome type C and D patients and certain type A and B patients and Seelos’ plans to develop SLS-005 in OPMD and other potential indications. 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 clinical studies and not gaining marketing approvals for its product candidates, 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, 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. (SEEL)
300 Park Ave., 12th Fl
New York, NY 10022