NEW YORK, Aug. 01, 2019 (GLOBE NEWSWIRE) -- Seelos Therapeutics, Inc. (SEEL), a clinical-stage biopharmaceutical company, today released its second quarter pipeline update.
“We have made tremendous progress on multiple programs,” emphasized Raj Mehra, Ph.D., Chairman and CEO of Seelos Therapeutics, “progressing with the initiation of a potentially pivotal study for SLS-005 in a broad spectrum of Sanfilippo syndrome A and B patients and including the C and D type patients in an expanded access program is a great achievement in an indication with paucity of therapeutic choices. We will further develop SLS-005 in other neurological indications such as oculopharyngeal muscular dystrophy (OPMD).”
“Simultaneously, we are finalizing the protocol for a proof-of-concept study in Suicidality/Acute Suicidal Ideation and Behavior in a broader depression population for SLS-002 in discussions with the FDA,” added Tim Whitaker, MD, Head of R&D. “We continue to make preparations to begin the PK/PD and DDI studies in Q3.”
“Additional preclinical studies are underway for SLS-007 to further characterize the peptides’ potential in targeting alpha-synuclein pathology in Parkinson’s Disease. This approach is complementary to our SLS-004 utilizing gene therapy to reduce the expression of alpha-synuclein.” Dr. Mehra continued, “we have assembled a team of seasoned pharmaceutical drug developers across all key functions and provided them with ample resources to execute on our strategic plans.”
Second Quarter Corporate Highlights
- Seelos acquired exclusive worldwide licensing of a gene therapy program targeting the regulation of the SNCA gene, which encodes alpha-synuclein expression, from Duke University. The company plans to study this approach, named SLS-004, initially in Parkinson's Disease (PD).
- The company announced it had scheduled a Type C meeting (face to face) with the FDA to take place over the summer to design and initiate a Proof of Concept study for SLS-002 (intranasal racemic ketamine) in suicidality.
- Seelos initiated additional in-vitro studies for further characterization of SLS-007 and is in the process of initiating proof of concept studies for in-vivo delivery in rodents. This will set up the target engagement studies in transgenic rodent models of Parkinson’s Disease.
- Warren W. Wasiewski, M.D., F.A.A.P. joined Seelos as Chief Scientific Officer and will lead the SLS-005 program in Sanfilippo syndrome and spearhead the trehalose program in oculopharyngeal muscular dystrophy (OPMD).
- Seelos (SEEL) was added to the Russell Microcap® Index.
Update on Pipeline Development
- SLS-002 (intranasal racemic ketamine) - In line with Seelos’ Investigational New Drug (IND) program, preparations are underway to initiate its phase I in Q3 2019 to further evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI) of SLS-002 in healthy volunteers.
- SLS-005 (trehalose) - In July, Seelos submitted the Investigational New Drug Application (IND) for an FDA/EMA open-label phase IIb/III trial in Sanfilippo syndrome type A and B patients and will expand inclusion of Sanfilippo type C and D patients, as well as type A and B patients who do not meet the trial entry criteria into a separate, expanded patient access study.
- Seelos announced the receipt of a grant from Team Sanfilippo Foundation to be used towards funding of the SLS-005 program.
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 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. (SEEL)
300 Park Ave., 12th Fl
New York, NY 10022