N-methyl amisulpride

LB Pharmaceuticals designed its phase 2 study to be considered a registrational trial. \n LB Pharmaceuticals has shared top-line data from a phase 2 schizophrenia trial, touting results that offer early support for its vision and putting it on track to start a pivotal study around the end of the year.The trial randomized 359 people with acutely exacerbated schizophrenia to receive one of three daily oral doses of LB-102 or placebo. LB-102 is a modified version of amisulpride, a dopamine inhibitor that was developed in the 1980s and marketed by Sanofi as a schizophrenia drug—Solian—outside the U.S. High doses of amisulpride are needed to achieve the optimum level of dopamine receptor occupancy.LB-102 could solve that limitation of amisulpride, enabling once-, rather than typically twice-, daily dosing while having superior efficacy and tolerability to the existing dopamine inhibitor and other drugs. The phase 2 trial represented a key test of that idea.LB Pharma saw statistically significant changes on the Positive and Negative Syndrome Scale (PANSS) after four weeks of treatment with all three tested doses of LB-102. Compared to placebo, patients on the low and middle doses of LB-102, respectively, had 5- and 4.7-point reductions in PANSS scores. The reduction in the smaller cohort that took the exploratory top dose was 6.8 points. Bristol Myers Squibb’s Cobenfy achieved an 8.4-point PANSS improvement over placebo after five weeks in a phase 3 trial that enrolled 256 people with schizophrenia experiencing acute psychosis. Neurocrine Biosciences saw placebo-adjusted improvements of up to 7.5 points in a phase 2 study of its would-be Cobenfy rival.Tolerability is central to LB Pharma’s pitch for the schizophrenia market, which is currently served by some drugs that are associated with side effects such as sedation and weight gain. Amisulpride is less prone to causing those side effects than other treatments. LB-102, like amisulpride, binds less to 5-HT2C, alpha-1 or H1 receptors than other treatments and could therefore enjoy the same tolerability benefits.LB Pharma saw one case of sedation across the 251 patients who took LB-102. Average placebo-adjusted weight gain was 2 kg. LB Pharma said the drug candidate’s safety profile was on par with amisulpride. The biotech will discuss the data in more detail at the J.P. Morgan Healthcare Conference next week and share more results later in the year. With phase 2 data in hand, LB Pharma plans to talk to regulators about starting a phase 3 trial late this year or early next year. The biotech designed the phase 2 study to be considered a registrational trial. There are also potential opportunities to study the lower dose of LB-102 in settings such as mood disorders.LB Pharma kept a fairly low profile in the past, raising funding from Deep Track Capital, TCG Crossover, Vida Ventures and Pontifax and moving through the clinic without making much noise. But the biotech has begun to speak up in recent months, publicizing its appointment of Heather Turner, who led Carmot Therapeutics to its $2.7 billion Roche buyout, as CEO and securing a slot at the J.P. Morgan event.