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Recently released positive phase 3 data for Pfizer's zavegepant likely to fuel already noted perceptions among prescribers that the brand will have a high responder rate. On February 16, The Lancet Neurology published the Phase 3 results of Pfizer's zavegepant for the acute treatment of migraine. The CGRP receptor antagonist nasal spray has met its co-primary endpoints that a single 10mg dose proved to be more effective than placebo for both pain freedom and freedom from the most bothersome symptom (MBS) at two-hours post-dose. Zavegepant provided relief from migraine pain in 15 minutes, lasting up to 48 hours, according to the release. Due to these promising results, zavegepant is expected to receive FDA approval for the acute treatment of migraine in early 2023. Pre-launch assessments of zavegepant, collected from a sample of 100 specialists, indicate that Pfizer's asset will be met with some cautious optimism. Specifically, respondents viewed zavegepant as a moderate advancement over other agents in this space, including Impel's Trudhesa, due to its preferred dosing formulation and anticipated responder rate. Trudhesa, the most recent acute treatment among migraine market entrants, is similar to zavegepant as both are nasal sprays, providing relief in as fast as 15 minutes with one dose and potentially allowing for up to two pain-free days. Though both products are administered intranasally, a major difference between the agents is that Trudhesa is a DHE (dihydroergotamine) while zavegepant is an anti-CGRP, similar to the more proven products, Pfizer's Nurtec ODT and AbbVie's Ubrelvy. Spherix is nearing completion of launch tracking of Trudhesa for its first 18 months of commercial availability. Results from the most recent Trudhesa deep dive launch assessment – fielded in December 2022 - reveal that uptake can be slow-to-moderate for a newly branded product entering this space. Nurtec ODT, a recent Pfizer purchase and available for the acute treatment of migraine since February 2020 and AbbVie's Ubrelvy, available since December 2019, show the highest physician-reported branded market share, while share of Trudhesa and Eli Lilly's Reyvow – on the market since October 2019 – account for just a fraction of use in comparison. Fortunately for Pfizer, zavegepant is expected to be available ahead of several other products currently in the pipeline for the acute treatment of migraine. Phase 3 products include Axsome's AXS-07, an oral anti-CGRP with FDA approval expected late 2023; Amneal's DHE autoinjector, expected to be submitted for approval in Q4 2023; and Satsuma's STS-101, a DHE product that would be the first powder nasal spray as opposed to liquid or injection. Once commercially available, Spherix Global Insights will probe U.S. neurologists and migraine specialists as part of its' monthly market tracking. Launch Dynamix™ service, which will continue for zavegepant's first eighteen months on the market. The service will also include a quarterly deep dive into reported patient share, brand perceptions, patient initiations/discontinuations, and drivers and barriers of prescribing. Since 2018, Spherix Global Insights has tracked the migraine market and will continue coverage of this ever-growing space. Uptake and impact of zavegepant will be closely monitored via the Launch Dynamix™ service, while RealTime Dynamix™ covers overall in-line use, perceptions, pipeline awareness and intent, and perceptions of acute and preventive treatments. New start and switching patient segments will be explored via RealWorld Dynamix™ services, including drivers of brand choice, treatment by acute and preventive products and severity levels, and potential next switches. About Launch Dynamix™ Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About RealTime Dynamix™ RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. About RealWorld Dynamix™ RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the "why" behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. About Spherix Global Insights Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company's unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers. A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology. SOURCE Spherix Global Insights

Mineralys Therapeutics’ hypertension drug candidate could offer a new treatment option for patients who don’t adequately respond to currently available blood pressure medicines. The once-daily pill is nearing a pivotal test, and Mineralys has raised $192 million in IPO cash to finance its clinical trial plans. When Mineralys set preliminary terms for the IPO last week, it planned to sell 10 million shares in the range of $14 to $16 per share. The Radnor, Pennsylvania-based company ended up adding 2 million shares to the offering, which priced late Thursday at the top of the projected price range. Those shares began trading Friday on the Nasdaq under the stock symbol “MLYS.” Many patients who have hypertension take multiple medications to manage the condition. However, more than half of the 115 million people in the U.S. with sustained elevated blood pressure fail to meet their blood pressure reduction goals, Mineralys says in its IPO filing. That failure puts these patients at greater risk of death due to cardiovascular disease or stroke. Standard-of-care drugs include angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), which work by lowering levels of aldosterone, a hormone that regulates blood pressure. Another class of drugs work by blocking aldosterone’s activity at the called mineralcorticoid receptor. Mineralys aims to address aldosterone, but in a different way than currently available medications. Its small molecule drug, lorundrostat (previously known as MLS-101), is an aldosterone synthase inhibitor (ASI). It blocks aldosterone synthase, an enzyme key to the synthesis of the hormone. The company says its molecule is highly selective, hitting its enzyme target without also hitting other targets, such as the hormone cortisol. “Several large pharmaceutical companies have tried to develop ASIs, but their efforts have been hampered due to insufficient selectivity for aldosterone, resulting in off-target toxicities associated with cortisol inhibition,” Mineralys said in the filing. “These challenges have led to the discontinuation of many ASIs in development to date.” Last November, Mineralys reported preliminary data from a placebo-controlled Phase 2 test enrolling 200 patients with uncontrolled or treatment-resistant hypertension. Those participants had been taking up to two anti-hypertensive drugs to manage their blood pressure. Results showed the study met its blood pressure reduction goals. Furthermore, the study drug was well tolerated by patients. Serious adverse events were reported in three participants. In two of them, the effects were deemed unrelated to the drug. The third patient had pre-existing below normal sodium levels in the blood, which reversed after stopping treatment with the Mineralys drug. The next step for lorundrostat is another Phase 2 study to evaluate the safety and efficacy of the molecule when used as an add-on therapy in patients who are taking two or three anti-hypertensive medications. This double blind, placebo-controlled study will enroll up to 240 adults and will start in the first half of this year. Meanwhile, Mineralys plans to start a Phase 3 study in the second half of this year. The trial design will be similar to that of the Phase 2 study except it will have more patients—up to 1,000 adults with uncontrolled or treatment-resistant hypertension. Preliminary data are expected in mid-2025. Mineralys also wants to see how its drug works addressing hypertension in patients with chronic kidney disease. A Phase 2 study is expected to start in the middle of this year. Mineralys is pursuing its clinical trial plans as rival CinCor Pharma prepares for a pivotal test of its aldosterone synthase inhibitor, baxdrostat. Despite failing in Phase 2 last November, the biotech reported encouraging results in a subgroup of patients that it said could inform the design of a Phase 3 study. AstraZeneca apparently sees potential in the CinCor drug. Last month, it agreed to pay $1.3 billion to acquire CinCor. Lorundrostat traces its origins to Mitsubishi Tanabe, which discovered the molecule and advanced it as far as Phase 1 testing. Venture capital firm Catalys Pacific founded Mineralys in 2019, according to the filing. The following year, Mineralys licensed global rights to lorundrostat, paying $1 million up front. The deal includes milestone payments of up to $9 million for development and $155 million if the drug reaches the market. Mineralys has raised $158 million since its inception, most recently a $118 million Series B financing last June led by RA Capital and Andera Partners. According to the prospectus, Catalys Pacific is Mineralys’s largest shareholder, owning a 24.1% post IPO stake, followed by Samsara Capital’s 9.7% stake. Mineralys’s CEO is Jon Congleton, a veteran of Impel NeuroPharma, Nivalis Therapeutics, and Teva Pharmaceutical Industries. The company reported its cash position was $110.4 million at the end of 2022. It estimates that this capital combined with the IPO proceeds will be sufficient to fund operations for at least the next 18 months—enough time for the two planned Phase 2 tests of lorundrostat to report preliminary data. Photo by Getty Images 内容来源于网络，如有侵权，请联系删除。