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Seelos Therapeutics

Seelos Therapeutics to embark on two key clinical trials in the third quarter

All eyes are on the New York company’s pharmacokinetics study linked to its promising SLS-002 intranasal ketamine depression drug

A patient who suffers depression
The clinical-stage biopharmaceutical company focuses on central nervous system, neurological and psychiatric disorders

Seelos Therapeutics Inc (NASDAQ:SEEL), a clinical-stage biopharmaceutical company, released a second quarter pipeline update Thursday showing it is embarking on two clinical trials in the third quarter.

The New York company has several drugs in the pipeline and Wall Street is bullish about the company’s SLS-002 intranasal ketamine depression drug aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide.

Seelos plans to begin its pharmacokinetics and pharmacodynamics study linked to SLS-002 in the second half of 2019.

READ: Seelos Therapeutics has catalysts for its ketamine depression drug, multiple shots on goal with a strong pipeline

Similarly, the company has filed an Investigational New Drug application with the US Food and Drug Administration for a clinical study of its drug SLS-005, also known as Trehalose, which is a protein stabilizer that activates a process that clears material from cells.

Seelos is collaborating with Team Sanfilippo Foundation, a non-profit foundation formed by parents of children with the degenerative condition.

The parties are expanding the study from its original parameters. In addition to the study for patients with Sanfillipo syndrome types A and B, which are more common, Seelos is now able to offer a separate expanded access study for patients with types C and D, as well as those with A or B who don’t meet the initial entry criteria.

SLS-005 targets a rare orphan disease 

“We have made tremendous progress on multiple programs,” said Seelos Therapeutics CEO Raj Mehra. “We are progressing with the initiation of a potentially pivotal study for SLS-005 in a broad spectrum of Sanfilippo syndrome…We will further develop SLS-005 in other neurological indications such as oculopharyngeal muscular dystrophy.”

Sanfilippo is a rare genetic condition in which the body doesn’t have certain enzymes to break down long chains of sugar molecules and it can cause fatal brain damage. Over time, young patients suffer a loss of speech and other cognitive skills, heart problems and often death prior to adulthood.

SLS-002 ketamine depression drug

“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,” said Tim Whitaker, head of R&D at Seelos Therapeutics. “We continue to make preparations to begin the PK/PD and DDI studies in the third quarter.”

Seelos has exclusively in-licensed the rights to a potential disease-modifying Parkinson’s disease therapy created by researchers at the University of California, Los Angeles (UCLA). As a result, it has the rights to a family of peptide inhibitors from UCLA that target the aggregation of alpha-synuclein (α-synuclein).

The function of α-synuclein proteins in the healthy brain is unknown, but Parkinson's researchers are interested in it because it is a major constituent of Lewy bodies, protein clumps that are the pathological hallmark of the neurological disorder.

Parkinson’s disease therapy

Seelos has named the new program SLS-007, with an initial focus on Parkinson's disease.

“Additional preclinical studies are underway for SLS-007 to further characterize the peptides’ potential in targeting alpha-synuclein pathology in Parkinson’s Disease,” said Mehra. 

“This approach is complementary to our SLS-004 utilizing gene therapy to reduce the expression of alpha-synuclein. 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.”

Seelos is evaluating the potential for in-vivo delivery of SLS-007 in a Parkinson’s disease transgenic mice model.

“Alpha-synuclein is a normal protein that all of us have,” said Mehra. “But it turns out that in Parkinson’s patients the accumulation of alpha-synuclein is always present and that has been identified as a key target.”

In July, Seelos Therapeutics was added to the Russell Microcap Index. Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. 

Seelos stock traded at $1.62 in fternoon trade.

—Adds stock price—

Contact Uttara Choudhury at [email protected]

Follow her on Twitter@UttaraProactive 

Quick facts: Seelos Therapeutics

Price: $1.22

Market: NASDAQ
Market Cap: $32.88 m
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