Once dismissed as a "party drug" for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression. The approval last month of Johnson & Johnson’s (NYSE:JNJ) ketamine-based depression treatment shines a light on another drug maker strongly advancing its own medication for depression. Seelos Therapeutics (NASDAQ:SEEL) is quickly filling the white space left by Big Pharma which largely abandoned research on badly needed new depression treatments.
Wall Street is bullish that New York clinical-stage biopharmaceutical company Seelos Therapeutics’ SLS-002 intranasal ketamine depression treatment under development is safe and will reach millions of patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at imminent risk of committing suicide.
J&J’s nasal spray SPRAVATO and Seelos’ SLS-002 nasal spray both have formulations of ketamine, with subtle differences. J&J’s nasal spray contains the esketamine compound, which is one half of the ketamine compound. However, Seelos Therapeutics’ nasal form of racemic ketamine is made of two mirror-image molecules and is likely to require a smaller dose because of its higher potency.
Proactive Investors sat down with Seelos Therapeutics CEO Raj Mehra to learn more about how the company’s ketamine drug can help depression sufferers. He also discussed the company’s strong late-stage pharmaceuticals pipeline.
Before founding Seelos in 2016, Mehra, who has five degrees, including a Ph.D and MBA from Columbia University, spent nine years at Auriga USA as a managing director focused on equity investments in global health care companies. He has also managed a hedge fund.
What is the backstory of Seelos Therapeutics?
In January, Seelos transitioned into a public company on the Nasdaq by completing a reverse merger with Apricus Biosciences. What were the benefits of the reverse takeover?
Based on investor meetings held when Seelos was private the demand was to fund Seelos to become a public entity for better access to additional investment capital. A reverse merger speeds up that process when you can find a suitable shell to merge with, like Apricus. The key benefit of the reverse takeover was it gave us access to the capital markets.
Johnson & Johnson's SPRAVATO nasal spray, which has a compound similar to the "club drug" ketamine, has now been approved by the FDA for treatment-resistant depression (TRD). What sets your SLS-002 drug apart from J&J’s drug?
J&J’s SPRAVATO is the single isomer (the S isomer) of ketamine, whereas our SLS-002 product candidate is the racemic version, which means it contains both the R and S isomer in equal proportions.
A Zanos publication shows in the animal depression model, that racemic/R ketamine has more potency and minimal side effects versus S-ketamine. Racemic/R ketamine has non-NMDA dependent effect through AMPA binding that S isomer can't achieve. More importantly, the R isomer seems to lack the negative psychoactive effects commonly associated with ketamine.
Additionally, SPRAVATO will be treating treatment-resistant depression, while we are treating suicidality with an underlying post-traumatic stress disorder (PTSD) or major depressive disorder (MDD). The key benefit of SLS-002 is that we hope to get these patients out of the ER/psychiatric hospital sooner using our drug.
When will you reach a key inflection point for your ketamine-based depression treatment?
We plan to begin our pharmacokinetics and pharmacodynamics study in the second half of 2019 and engage the FDA in discussions for the next steps for a pivotal trial after that data. After we complete the study and review the data, Seelos plans to request a post-Phase II meeting with the FDA to discuss trial design requirements for a pivotal study.
How will you overcome the stigma attached to ketamine-based drugs?
SLS-002 will be a low dose of ketamine compared to its use in the anesthetic setting. It will only be administered in the ER setting, and we are making it a single-use device to make its administration safe and convenient.
What are some of your other potential blockbuster candidates and late-stage pipeline of products?
We have SLS-005 which is targeting orphan diseases of the central nervous system. SLS-005 or trehalose which is a protein stabilizer will begin a pivotal trial in Sanfilippo Syndrome in the second quarter, funded by the Team Sanfilippo Foundation. 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. It’s referred to as a childhood disease because most patients never reach adulthood.
The Team Sanfilippo Foundation is finalizing the protocol for an up to 20 patient open-label Phase 2B study. Seelos will provide the drug for the 52-week study as well as an extension study and own the data that comes out of the trial. The first patient with Sanfilippo is expected to be dosed with trehalose in the Phase 2b trial in the second quarter of 2019.
SLS-005 has safe and effective data in other disorders such as OPMD, which is a type of muscular dystrophy, and Spinocerebellar ataxia type 3 (SCA3), a condition characterized by progressive problems with movement, which we may pursue after Sanfilippo.
READ: Seelos Therapeutics extends gains on license of potential Parkinson's candidate created at UCLA
Separately, 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). We have the rights to a family of peptide inhibitors from UCLA that target the aggregation of alpha-synuclein (α-synuclein). SLS-007 is a peptide-based approach targeting the NACore of alpha synuclein for Parkinson's.
Seelos will evaluate the potential for in-vivo delivery of SLS-007 in a Parkinson’s disease transgenic mice model in the second quarter. If we finish the target engagement study successfully in transgenic mice it will be exciting news for Seelos.
How big is the addressable market?
The market for our SLS-002 depression drug is very large as more than 900,000 people were admitted to the ER for suicidality even though no effective drug treatment exists. On the other hand, SLS-005 indication for Sanfilippo Syndrome has 1,000 patients in the United States and OPMD has close to 20,000 patients worldwide. Again, SLS-007 has a large addressable market as there are nearly six million patients worldwide with Parkinson’s disease.
What is the financial standing of the company?
Seelos raised $18 million in January in conjunction with the merger.
Please tell investors why Seelos Therapeutics is a good investment?
For a small company, Seelos has multiple assets in development with massive potential. Success in any one program justifies the investment at this time. Having three strong candidates is almost like having three companies under one roof. It gives us multiple shots on goal.
—This article has been lightly edited —
Contact Uttara Choudhury at [email protected]