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(Incorporated in Delaware)
We are a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. Through our differentiated approach, we identify clinically validated mechanisms with established efficacy and safety profiles which had historically been limited by high first-pass metabolism, low bioavailability, and/or side effects. We apply our proprietary GlyphTM platform to overcome those limitations and invent innovative oral therapies. Glyph is a lymphatic-targeting prodrug technology which is designed to bypass first-pass metabolism and thereby enhance a drug’s oral bioavailability and reduce side effects. This process, which we call “Glyphing,” also creates new composition of matter intellectual property. Our experienced team of industry leaders has a proven track record in neuropsychiatry drug discovery and development and delivering successful business outcomes. We aim to develop novel, leading treatment options that will make a significant impact for patients and their families.
Our lead product candidate, GlyphAlloTM (SPT-300 or Glyph Allopregnanolone), is a novel, Glyphed oral prodrug of allopregnanolone, an endogenous molecule that has been clinically validated in third-party trials for the treatment of postpartum depression, or PPD, a form of major depressive disorder, or MDD, that shares symptomatology with MDD, as a rapidly acting antidepressant with anxiolytic and sleep-promoting effects. Additionally, an oral synthetic analog of allopregnanolone, zuranolone, demonstrated a rapid antidepressant effect that deepened while patients were on drug and met the primary endpoint in five of the six trials in MDD. GlyphAllo is designed to overcome bioavailability limitations of allopregnanolone and deliver rapid and durable efficacy in MDD. We have demonstrated in a Phase 1 clinical trial that GlyphAllo reaches therapeutically relevant exposures with oral dosing, and in a Phase 2a clinical trial, GlyphAllo demonstrated initial proof-of-concept with an objective biomarker of stress in healthy volunteers and a favorable tolerability profile. We have initiated the Phase 2b BUOY-1 trial in patients with MDD with or without anxious distress and anticipate topline data in the first half of 2027.
Our second product candidate, GlyphAgoTM (SPT-320 or Glyph Agomelatine), is a novel, Glyphed oral prodrug of agomelatine, a clinically validated anxiolytic and antidepressant that is approved for the treatment of generalized anxiety disorder, or GAD, in Australia and MDD in Australia and the European Union, or EU. In April 2026, we reported topline data from the single-ascending dose, or SAD, and crossover portions of our Phase 1 proof-of-concept clinical trial for GlyphAgo. In the head-to-head crossover portion of the trial, GlyphAgo demonstrated a 6.8-fold increase in bioavailability of agomelatine compared to unmodified orally administered agomelatine, and showed significantly lower (10-fold) pharmacokinetic variability compared to unmodified agomelatine. In the SAD portion of the trial, GlyphAgo demonstrated a 9.6 to 14.5-fold increase in dose-normalized exposure compared to agomelatine. GlyphAgo was well-tolerated and no liver-related adverse events, or AEs, were observed. We plan to initiate a Phase 2a proof-of-pharmacology trial designed to evaluate the potential sleep benefit of GlyphAgo in patients with GAD and sleep disturbance, with topline data expected in early 2028 and, in parallel, a Phase 2b trial designed to evaluate efficacy and safety of GlyphAgo in patients with GAD, with topline data expected by the end of 2028.
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