Dopamine hydrochloride

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.

Phase 2b study will evaluate the safety and efficacy of gemlapodect (NOE-105) in patients with Tourette syndromeBASEL, Switzerland, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Noema Pharma AG, a clinical-stage neuroscience-based company, today announced the first patients have been dosed in a global Phase 2b study evaluating the safety and efficacy of gemlapodect (NOE-105) in Tourette syndrome. NOE-TTS-201 (NCT06315751) is a Phase 2b, 12-week, randomized, double-blind, placebo-controlled study that is designed to examine the safety and efficacy of gemlapodect. The trial will enroll 140 patients with Tourette syndrome in multiple centers in the US and Europe. Patients will be treated with up to 15 mg of gemlapodect once daily, or a matching placebo. The primary endpoint is the Yale Global Tic Severity Scale (YGTSS) Total Tic Score. “Patients with Tourette syndrome carry an incredible burden related to the expression of motor and vocal tics with limited treatment options,” said Ilise Lombardo, M.D., Chief Executive Officer of Noema Pharma. “I am happy to announce the progression of the development of gemlapodect in Tourette syndrome with the dosing of the first patients in our Phase 2b trial.” About Tourette Syndrome Tourette syndrome is a neurodevelopmental disorder in the wider spectrum of tic disorders, consisting of motor and vocal abrupt and brief movement or sound which is preceded by a local or generalized urge/premonitory sensation. TS impacts over a half-million individuals and families in the US alone, as well as millions of individuals worldwide. About NOE-105/gemlapodect NOE-105/gemlapodect is a potential first-in-class phosphodiesterase-10A (PDE10A) inhibitor in mid-stage clinical development as a dopamine modulator for Tourette syndrome. NOE-105 has been well-tolerated in studies with healthy volunteers and in patients with Tourette syndrome. NOE-105 has the potential to achieve a more targeted effect by modulating dopamine signaling exclusively in the medium spiny neurons of the striatum in the brain, while limiting off-target effects compared to other dopamine antagonists. About Noema Pharma Noema Pharma is a clinical-stage biotech company advancing a portfolio of transformative therapeutics utilizing first-in-disease approaches targeting neuroscience-based conditions with high unmet need. Noema has four programs currently in active Phase 2 clinical trials evaluating pain in Trigeminal Neuralgia, seizures in Tuberous Sclerosis Complex, Tourette syndrome and vasomotor symptoms plus associated symptoms of menopause with readouts expected in 2025. Noema was founded by leading venture capital firm Sofinnova Partners and is supported by current investors including Forbion, Gilde Healthcare, Invus, Jeito Capital, Polaris Partners and UPMC Enterprises. Learn more at www.noemapharma.com. Investor Contact: Precision AQAlex Lobo212-698-8802alex.lobo@precisionaq.com