Clinical-stage biopharmaceutical company Seelos Therapeutics Inc. (Nasdaq: SEEL) entered into a Department of Defense-funded trial to evaluate treatments for post-traumatic stress disorder in military personnel.
The trial, an adaptive platform study, is designed to test multiple treatments simultaneously, a method that aims to enhance efficiency in clinical research. SLS-002, which is an intranasal form of racemic ketamine, will be evaluated for its effectiveness in reducing symptoms of PTSD, a condition prevalent among veterans and active-duty service members.
Seelos’ participation in this trial is an extension of its existing research focus, previously centered on acute suicidal ideation and behavior in major depressive disorder. The move into PTSD treatment research fits a growing need within military and veteran communities, Seelos’ CEO and chairman Raj Mehra said in a statement Monday.
The trial includes a 30-day screening period, a 12-week treatment phase, and a subsequent four-week safety evaluation. It will employ a range of measurement tools, such as the Clinician-Administered PTSD Scale-5-Revised and the Columbia Suicide Severity Rating Scale, to gauge the impact of the treatments.
According to the U.S. Department of Veterans Affairs, PTSD is a major issue, affecting a sizable portion of the U.S. population, with higher incidence rates among veterans. The current available treatments for PTSD have limitations, highlighting the need for more effective therapeutic options.
The trial is a collaboration between Seelos and the Warfighter Readiness, Performance, and Brain Health Project Management Office of the U.S. Army Medical Materiel Development Activity.
Should the study yield positive outcomes, Seelos may be positioned to approach the U.S. Food and Drug Administration to request approval for SL-002, potentially fast-tracking its entry into the health care market, according to Seelos spokesperson Anthony Marciano.
The study, which is fully funded by the Department of Defense and estimated to have 600 participants, is larger in scope than the company’s current studies with the drug.
“If the study is big enough, we should be able to be approved off of this,” Marciano told Green Market Report. “That’s because we have chosen we have chosen one dose. This could be data that we could file with with the FDA, potentially.”
He also highlighted SL-002’s market potential by pointing to another intranasal drug with a similar offering, Johnson and Johnson’s esketamine nasal spray, Spravato.
“This is really more about collaboration and who we’re helping, but at the end of the day, it comes down to what does this mean to the investors as far as the business opportunity?” Marciano said.
The treatment plan for SL-002 involves administering five doses over two weeks, which mirrors the approach used for other treatments for PTSD. The overall treatment plan suggests a more prolonged 12-week course, likely involving twice-weekly dosing initially, then weekly for the remaining period, totaling approximately 16 doses per patient.
This represents a huge market opportunity, Marciano noted. With an estimated charge of $800 per dose, the cost per patient could be about $12,000. If 1 million of the 13 million PTSD sufferers in the U.S. used this treatment, it could create a $12 billion annual market.
However, Green Market Report previously reported that the firm’s most recent 147-patient Phase 2 trial failed to achieve meaningful signals for its primary endpoint. Those results came after the company had already engaged with the government about partnering for the study, which Marciano says began more than a year and a half ago.
Financial setbacks were cited at the time, though the company has since partnered with a large investment bank to provide extra runway, according to Marciano.
He added that certain properties of the company’s design with the nasal spray device manufacturer, Aptar, is patented.
“We’ve totally changed the characteristics of the drug and we are safety profile is way better than IV and the efficacy is actually exceptional,” he said. “The intranasal administration actually changes some of the characteristics of the drug. That’s what makes it patentable.”
Moreover, a co-exclusivity agreement deal means that the the device manufacturer will only work with Johnson and Johnson’s Spravato and Seelos’ racemic ketamine, Marciano said.
“So, it’s already an FDA-approved device. And again, this means if anyone were trying to copy us, you would infringe on the device as well,” he said.
Seelos on Friday announced a 1:30 reverse stock split, which is set to take affect Tuesday. The reverse stock split will reduce its shares from around 167.7 million to 5.6 million, the company said.
The company’s shares were down 15% Monday morning.
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