NEW YORK, April 08, 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 provides its first quarter business update and pipeline developments.
While the COVID-19 outbreak is reaching unprecedented pandemic levels globally, Seelos empathizes with those experiencing the devastating loss of life and the transformation of their daily lives. History has shown that the need for mental health treatment surges surrounding tragedies that have caused a major loss of human life, financial disruptions and increased unemployment. As we work through this crisis, we are acutely aware of the issues that may grow and likely persist in the aftermath.
Seelos is on the frontline of mental health research and is progressing on schedule with its clinical development of SLS-002 in Acute Suicidal Ideation and Behavior (ASIB) in patients with Major Depressive Disorder (MDD). Addressing ASIB continues to be our top priority and the ongoing pandemic has heightened its importance as healthcare providers continue to work to develop a novel treatment for these patients in need.
“Currently, the work on all our programs is progressing as scheduled, and the FDA has been very accommodating by providing virtual and telephonic interactions for guidance in lieu of face-to-face meetings”, said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “We have a talented and extremely experienced team driven to advance our programs and look forward to continuing to update our shareholders.”
Seelos expects to release additional safety data on the Phase I studies of SLS-002 in the second quarter, details from the Type C meeting with FDA and updates to other key programs such as SLS-005 and SLS-007.
- Phase I dosing for all 104 patients was completed as scheduled.
- Preliminary safety data to date have been highly encouraging. There have been no serious adverse events (SAEs), the super-majority of the adverse events (AEs) have been mild and transient in nature and all subjects completed the study.
- Seelos is on schedule to lock and unblind the Phase I data in the second quarter of 2020 and will release additional data once unblinded.
- The Type C meeting with the FDA successfully concluded as scheduled last month and provided a path forward for the Proof of Concept study in ASIB in MDD.
- Last month, Seelos announced it had received a written response from the European Medicines Agency (EMA) with guidance to design an open-label, non-placebo controlled, Phase IIb/III pivotal study for the treatment of patients with Sanfilippo syndrome types A and B in the European Union.
- Seelos is continuing discussions with the FDA regarding the use of Sanfilippo syndrome natural history data as a control for a pivotal study in the U.S. Seelos is currently collecting additional natural history data for that purpose.
- Requests for Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) for SLS-005 in Sanfilippo Syndrome have been submitted to the FDA.
- Seelos is working on finalizing a protocol for a pivotal study in Oculopharyngeal Muscular Dystrophy (OPMD) and expects to provide details after interacting with the FDA.
SLS-004 & SLS-007
- Seelos is continuing with pre-clinical work on both Parkinson’s disease programs, and details of the protocol for SLS-007 will be released upon approval by our scientific advisers.
- Pre-Investigational New Drug (IND) work is continuing for SLS-008.
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 with respect to the timing for releasing data from the Phase I study of SLS-002, expected emergency department need for treatments for ASIB, expectations regarding the safety data of SLS-002, including adverse events and hemodynamic profiles, Seelos’ plans to release additional data from the Phase I study of SLS-002, Seelos’ plans to disclose the general outline of the Type C meeting with the FDA, the design of the SLS-005 study in the European Union, the use of natural history data of Sanfilippo syndrome patients in SLS-005 studies, expectations regarding requests for Rare Pediatric Disease Designation and Orphan Drug Designation for SLS-005 in Sanfilippo Syndrome, expectations regarding a pivotal study in Oculopharyngeal Muscular Dystrophy (OPMD), Seelos’ plans to release details of the protocol for a pivotal study in OPMD, expectations regarding preclinical work on SLS-004 and SLS-007 for Parkinson’s disease, Seelos’ plans to release details of the protocol for SLS-007 and expectations regarding pre-Investigational New Drug work for SLS-008. 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 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 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.