CGRP receptor

VALBY, Denmark, April 4, 2025 /PRNewswire/ -- H. Lundbeck A/S (Lundbeck) will present positive interim results from the open-label extension of the PACIFIC trial investigating bexicaserin, in addition to new analyses from clinical trials and real-world data with eptinezumab. H. Lundbeck A/S (Lundbeck) today announced that recent pipeline data will be presented at the 2025 AAN Annual Meeting in San Diego, U.S. The data includes an oral presentation of the six-month results from the open-label extension (OLE) of the Phase 1b/2a PACIFIC trial of bexicaserin, a novel treatment under development for seizures associated with Developmental and Epileptic Encephalopathies (DEEs).1 DEEs are the most severe group of epilepsies characterized by drug-resistant seizures, and developmental slowing or regression.2 "DEEs can be caused by a range of acquired, syndromal, and genetic etiologies, with more than 900 genes implicated. However, only a few subtypes currently have approved therapies, leaving many patients in need. The DEE-inclusive PACIFIC trial and six-month OLE data indicate that bexicaserin may be able to help address this unmet need across multiple DEE types, and highlights Lundbeck's expanding commitment to the neuro-rare space. We look forward to engaging with the global neuroscience community at AAN to discuss the data and potential of bexicaserin to support patients, caregivers and healthcare professionals in the management of DEEs," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. The OLE included patients who successfully completed the PACIFIC trial3 and was designed to evaluate the long-term safety (up to 52 weeks), tolerability, and efficacy of bexicaserin in a cohort of participants with DEEs who were newly exposed to bexicaserin for at least 6 months.1 The OLE interim analysis showed that bexicaserin continues to exhibit a favourable safety and tolerability profile at six months, consistent with the safety profile observed during the PACIFIC trial. All bexicaserin treatment-naive patients (n=9) successfully transitioned from placebo to bexicaserin, reinforcing the tolerability of bexicaserin in an inclusive DEE population. In this placebo-bexicaserin switch population, a 57.3% reduction in countable motor seizures and 61.2% reduction in total seizures was observed, consistent with the response in non-naive participants at 6 months (n=32).* Moreover, more than half of patients newly exposed to bexicaserin (n=5/9) experienced a ≥50% reduction from baseline in countable motor seizures.1* In addition, Lundbeck will present recent post-hoc analyses and real-world data for eptinezumab investigating meaningful endpoints, such as good days per month†, and sustained treatment response. Lundbeck remains focused on raising the bar around preventive treatment expectations in migraine and increasing the understanding of the holistic impact of migraine on quality of life. *As compared to baseline at entry into PACIFIC study. †As reported by trial patients based on individual migraine experience Details of Lundbeck presentations at AAN 2025: Bexicaserin Oral Presentation Monday, April 7, Session S20, 4:18 – 4:30pm PT Title: Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension Eptinezumab Poster Presentations: Title: Long-term Maintenance of ≥50% and ≥75% Migraine Response With Eptinezumab in Patients With High-frequency Episodic Migraine and Chronic Migraine and 2-4 Prior Migraine Preventive Treatment Failures4 I Poster number: P12.005 Title: Patient-reported Impact of ≥75% Increase in Good Days/Month on Migraine Symptoms, Quality of Life, and Brain Fog: Real-world Study of Adults With Chronic Migraine Treated With Eptinezumab5 I Poster number: P12.010 Title: Long-term Reductions in Monthly Headache Days With Eptinezumab Treatment in Adults With Chronic Migraine: Results From the PREVAIL Study6 I Poster number: P12.003 About Bexicaserin Bexicaserin (LP352) is an oral, centrally acting 5-hydroxytryptamine 2C (5-HT2C) receptor superagonist with no observed impact on 5-HT2B and 5-HT2A receptor subtypes. It is being evaluated in a global Phase III clinical program (the DEEp Program). The FDA has granted Breakthrough Therapy designation for bexicaserin for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs) for patients two years of age and older. Bexicaserin is an investigational compound that is not approved for marketing by any regulatory authority worldwide. The PACIFIC trial was a randomised, double-blind, placebo-controlled, DEE-inclusive trial (NCT05364021) in 52 participants with Dravet syndrome, Lennox-Gastaut syndrome, or DEE Other, who had ≥4 countable motor seizures during the 28-day baseline period, and who were on a stable regimen of 1 to 4 concomitant antiseizure medications.3 About eptinezumab (Vyepti®) Eptinezumab is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) which was purposefully developed for IV administration. The efficacy and safety of eptinezumab 100 mg and 300 mg was investigated in two phase III clinical trials (PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine), where eptinezumab met its primary endpoint of decrease in mean monthly migraine days (MMD) over weeks 1-12 in both episodic and chronic migraine. Furthermore, the clinical trial program observed a treatment benefit over placebo that was observed for both doses of eptinezumab as early as day 1 post-infusion. The safety of eptinezumab was evaluated in more than 2,000 adult patients with migraine who received at least one dose of eptinezumab. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Approximately 8% of patients on 300 mg, 6% of patients on 100 mg and 6% of patients on placebo in PROMISE-1 and PROMISE-2 experienced nasopharyngitis. In PROMISE-1 and PROMISE-2, 1.9% of patients treated with eptinezumab discontinued treatment due to adverse reactions. Eptinezumab was approved by the U.S. Food and Drug Administration (FDA) for the preventive treatment of migraine in adults in February 2020, and in January 2022, eptinezumab was granted marketing authorization by the European Medicines Agency (EMA) for the prophylaxis of migraine in adults who have at least four migraine days per month. Today, eptinezumab is launched in the U.S. market, as well as in more than 30 markets worldwide. About H. Lundbeck A/S Lundbeck is a biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world's population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole. Lundbeck has approximately 5,500 employees in more than 50 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site and connect with us via LinkedIn. References: 1. American Academy of Neurology Annual Meeting 2025. Safety, Tolerability, and Efficacy of Bexicaserin in a Cohort of Participants with Developmental and Epileptic Encephalopathies: Interim Results of a Phase 1b/2a PACIFIC Study Open-Label Extension. 2. Sheffer I, et al. Epilepsia. 2025 Feb 27.doi: 10.1111/epi.18265. 3. Kaye R, et al. Efficacy and safety of bexicaserin (LP352) in adolescent and adult participants with developmental and epileptic encephalopathies: Results of the phase 1b/2a PACIFIC study. Presented at the Annual Meeting of the American Academy of Neurology; April 13-18, 2024 4. Ailani J, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. 5. Argoff C, et al. Poster presentation. American Academy of Neurology Annual Meeting 2025. 6. Starling A, et al. Poster Presentation. American Academy of Neurology Annual Meeting 2025. CONTACT: H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Denmark +45 3630 1311 [email protected] This information was brought to you by Cision The following files are available for download: SOURCE H. Lundbeck A/S WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

A recent settlement resolves allegations that Biohaven induced doctors to write Nurtec prescriptions by paying “improper remuneration," including through speaker payouts and meals at “high end restaurants." Over the years, the U.S. Department of Justice (DOJ) has taken a host of drugmakers to task over alleged kickback payments intended to boost prescriptions. Recently, Pfizer found itself in the agency's crosshairs thanks to one of its M&A plays.Now, Pfizer—which purchased neuroscience specialist Biohaven for $11.6 billion in 2022—is committing more than $59.7 million to resolve the kickback allegations against its subsidiary, the DOJ said Friday.The claims and ensuing settlement revolve around Biohaven’s CGRP receptor antagonist Nurtec ODT, which is cleared to both treat and prevent migraines in adults. The drug, which was the crown jewel in Pfizer’s Biohaven buyout, delivered $928 million in 2023 sales. Pfizer reports its fourth-quarter 2024 financial results next week, and the drug is expected to cross the $1 billion mark for the first time.The settlement resolves allegations—brought forward in a 2021 whistleblower lawsuit—that Biohaven induced doctors to write Nurtec prescriptions by paying “improper remuneration," including through speaker payouts and meals at “high end restaurants," according to a DOJ press release on Monday.Prescribers who attended multiple educational programs on the same topic “received no educational benefit from attending repeat programs,” the DOJ said in its release, while other Biohaven speaker programs were attended by people with no educational need to be there, such as speakers’ spouses, family members or friends.Pfizer’s buyout of Biohaven officially closed Oct. 3, 2022.“The settlement relates to alleged conduct at Biohaven before Pfizer’s acquisition of the company in October 2022 and does not include any admission of liability or wrongdoing,” a Pfizer spokesperson said in an emailed statement.Pfizer is “pleased to put this legacy matter behind us, so that we can continue to focus on the needs of patients," the company's spokesperson said. The allegations against Biohaven first came to light when an ex-staffer filed a whistleblower lawsuit against her former company in the summer of 2021. As part of the deal with the DOJ, the former staffer is in line to receive roughly $8.4 million as her share of the federal settlement, the government explained.While Nurtec was already on a rapid ascent by the time of Biohaven’s acquisition, Pfizer has helped raise the migraine med’s profile even more thanks in part to an ad campaign with award-winning musician and actor Lady Gaga.Biohaven isn't alone in facing allegations over kickbacks in recent years.Last fall, Teva Pharmaceuticals USA and Teva Neuroscience forked over a combined $450 million in a DOJ settlement to resolve claims that they leveraged assistance foundations to fund patients’ copays for the multiple sclerosis blockbuster Copaxone from 2006 through 2017. Prior to that, Biogen in 2022 finalized an agreement to pay $900 million to resolve a lawsuit alleging it paid kickbacks to doctors over a five-year span to boost sales of its own multiple sclerosis drugs. Novartis has also found itself in the DOJ’s sights, paying more than $642 million in 2020 to resolve claims that it offered kickbacks to doctors and illegal copayment support to Medicare to improve pharmaceutical sales. 

SAN DIEGO--( BUSINESS WIRE )--Nuvie Bio, a new clinical-stage biopharmaceutical company dedicated to addressing the most pressing unmet medical needs in migraine and related neurological diseases, announced completion of a first-in-human trial with NVI-100, the company’s lead investigational drug for the acute treatment of migraine. NVI-100 is a first-in-class water-soluble peptide antagonist for the calcitonin gene-related peptide (CGRP) receptor delivered via a patient-friendly autoinjector for the acute treatment of migraine. The Phase 1 study in healthy volunteers has shown that NVI-100 is well-tolerated and achieves rapid, high and consistent plasma levels. Nuvie Bio plans to file an Investigational New Drug (IND) application for NVI-100 later this year, clearing the way for the start of its Phase 2 clinical trial. “ We are developing the first rapidly absorbed subcutaneous CGRP receptor antagonist, with the goal to provide rapid relief from migraine to millions of people who are not satisfied with existing therapies,” said Pierre Rivière, Ph.D., co-founder and CEO of Nuvie Bio. “ We are extremely pleased with the results of the NVI-100 Phase 1 study. The human pharmacokinetics data support that NVI-100 is the first CGRP receptor antagonist with the potential to deliver fast, high and consistent efficacy, which combined with the tolerability associated with this clinically validated mechanism of action, could profoundly transform the acute treatment of migraine.” “ It is an exciting time to be involved in caring for people with migraine because of the significant advancements in treatments we have seen in recent years,” said Richard B. Lipton, M.D., Professor and Vice Chair of Neurology, Albert Einstein College of Medicine, and director, Montefiore Headache Center. “ NVI-100 has the potential to be the next breakthrough in acute treatment, providing rapid relief of migraine through subcutaneous administration with the high tolerability we associate with CGRP-targeted therapies.” Nuvie Bio was co-founded by Pierre Rivière, Ph.D., CEO; Frank Porreca, Ph.D., CSO; and David Dodick, M.D., chair of the scientific advisory board. Their combined expertise spans basic and clinical science in migraine and peptide therapeutics research and development. Working alongside them is a senior management team that has significantly contributed to previous therapeutic innovations in migraine. Originally discovered by Ferring Pharmaceuticals, NVI-100 (also known as AXN-001, FE205030) is now under exclusive worldwide development and commercialization rights by Nuvie Bio. About Migraine Migraine is the second most disabling neurological disease globally, disproportionately affecting women (about 3:1 female:male prevalence ratio). Migraine impacts over one billion people worldwide and accounts for over 45 million disability-adjusted life-years (DALYs). One DALY represents the loss of the equivalent of one year of full health. Despite recent advancements in migraine treatment, patients and healthcare providers continue to seek better acute treatments, particularly those offering “speed to relief that is tolerable.” About Nuvie Bio Nuvie Bio is a clinical-stage biopharmaceutical company on the forefront of innovation in neuroscience. Meaning "New Life," Nuvie Bio’s mission is to offer a better life to millions of people impacted by migraine and related neurological diseases. Nuvie Bio’s lead investigational drug, NVI-100, is a first-in-class water-soluble peptide CGRP receptor antagonist to be given subcutaneously by autoinjector for the acute treatment of migraine. NVI-100 is designed to deliver fast relief that patients can tolerate, eliminating the need to choose between efficacy and tolerability. The company is led by an executive team with decades of neuroscience and migraine product development and commercialization experience and is supported by a scientific advisory board of preeminent experts in migraine and brain disorders. For more information, visit www.nuviebio.com .