Seelos Therapeutics Inc (NASDAQ:SEEL) updated investors Friday on the progress of its drug pipeline during the third quarter, which included Food and Drug Administration acceptance of its Investigational New Drug Application for its Sanfilippo syndrome treatment.
The company received the green light from the FDA on August 22 for the drug, known as SLS-005 or trehalose, and plans to move ahead with clinical trials.
Meanwhile, Seelos is initiating Phase 1 studies of SLS-002, the company’s intranasal ketamine depression drug aimed at patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide.
The studies will be conducted in healthy volunteers and are meant to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interactions (DDI).
“Seelos continued to make significant progress in the third quarter on several of our programs,” CEO Raj Mehra said in a statement. “We expect screening and dosing to commence in the phase IIb/III trial in Sanfilippo syndrome in the US for SLS-005, and in the PK/PD/DDI studies for SLS-002. As a result, we envision multiple clinical studies in these two programs next year. Getting these studies launched in consultation with the FDA, completing a financing, and ringing the opening bell at Nasdaq have kept us very busy and has continued to raise awareness of our company.”
The company said it completed a $6.7 million registered direct offering with certain institutional investors in August, and it received a grant from Team Sanfilippo Foundation to fund studies of SLS-005.
The New York company also had a face-to-face meeting with the FDA to discuss the design of a potential Proof of Concept study for SLS-002. Based on agency feedback, Seelos is planning to conduct a Phase to PoC study in patients with MDD at imminent risk of suicide.
Additionally in the third quarter, Seelos began the ground work for another Investigational New Drug application, this time for SLS-008, a treatment it plans to develop for pediatric esophagitis. The condition is considered an orphan disease, a rare affliction that affects fewer than 200,000 people nationwide.
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