WhatsApp WhatsApp BOSTON–(BUSINESS WIRE)–Feb 24, 2021– Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that results from the EMERGENT-1 Phase 2 clinical trial evaluating KarXT for the treatment of schizophrenia were published in the New England Journal of Medicine (NEJM). “The publication of the EMERGENT-1 Phase 2 trial results in the peer-reviewed New England Journal of Medicine reinforces earlier clinical and preclinical data that KarXT’s modulation of muscarinic receptor function in the brain improves the symptoms of psychosis in schizophrenia, and underscores the potential of KarXT to offer a novel approach to treating this serious and disabling condition,” said Steve Brannan, M.D., chief medical officer of Karuna Therapeutics and lead author of the manuscript. “These findings support the potential for KarXT to treat symptoms of psychosis in schizophrenia without producing the common problematic side effects of current therapies, such as weight gain and extrapyramidal symptoms. Given these encouraging results, we have advanced KarXT into Phase 3 clinical development in our efforts to provide a meaningful, new, non-dopaminergic treatment option for this serious neuropsychiatric disorder affecting more than 21 million people worldwide.” The double-blind, placebo-controlled, five-week inpatient EMERGENT-1 Phase 2 trial enrolled 182 adults with an acute exacerbation of schizophrenia. In this trial, a twice-daily, flexible-dose treatment with KarXT demonstrated a statistically significant and clinically meaningful 11.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at Week 5, the primary outcome measure of the study, with an effect size of 0.75 (p<0.0001). Results published in NEJM also include data for pre-specified secondary outcome measures. Four of the five pre-specified secondary outcome measures, including PANSS positive symptom subscore, PANSS negative symptom subscore, PANSS Marder negative symptom subscore, and Clinical Global Impression – Severity frequency counts, showed statistically significant reductions following treatment with KarXT compared to placebo at Week 5 (p<0.001). KarXT was generally well-tolerated, with similar discontinuation rates between KarXT and placebo arms, both overall (20% vs. 21%) and due to treatment-emergent adverse events (2% in both arms). The most common adverse events associated with KarXT, including constipation, nausea, dry mouth, dyspepsia and vomiting, were mild-to-moderate in severity and were not associated with treatment discontinuation. Rates of nausea, vomiting, and dry mouth decreased over the course of the trial, while rates of constipation remained essentially constant. Incidences of somnolence, weight gain and extrapyramidal symptoms, which are common problematic side effects of current antipsychotic therapies, were similar in the placebo and KarXT treatment groups. “Many people living with schizophrenia have persistent symptoms, experience poor quality of life and impaired ability to function, despite treatment with current antipsychotic drugs,” said Jeffrey Lieberman, M.D., professor and chairman of the Department of Psychiatry, Columbia University, College of Physicians and Surgeons, member of Karuna’s scientific advisory board, and co-author of the manuscript. “The clinical trial results with KarXT highlight its potential to be a differentiated treatment option with a completely new mechanism of action for people living with schizophrenia, offering relief from acute psychotic symptoms without the debilitating side effects associated with the current standard of care.” The published manuscript titled “Muscarinic Cholinergic Receptor Agonist and Peripheral Antagonist for Schizophrenia,” is available online, and will appear in the February 25, 2021 issue of NEJM. About KarXT KarXT, a proprietary oral modulator of muscarinic cholinergic receptors, is Karuna’s lead product candidate. It combines xanomeline, a novel muscarinic agonist, with trospium, an FDA-approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system. This novel product candidate, if approved, has the potential to usher in a new treatment paradigm and dramatically impact patients with schizophrenia and other psychotic disorders by providing a differentiated mechanism of action relative to current D2 dopamine and serotonin receptor-targeting antipsychotic drugs. About Schizophrenia Schizophrenia is a chronic and often disabling brain condition affecting how a person thinks, feels and behaves. It is estimated to affect more than 21 million people worldwide, and has a young age at onset, typically presenting during late adolescence to early adulthood. Symptoms of schizophrenia generally fall into three categories – positive (delusions, hallucinations, and difficulty organizing and expressing thoughts), negative (difficulty enjoying life and withdrawal from others) and cognitive (deficits in memory, concentration and decision making). Given the nature of these symptoms, schizophrenia can affect all areas of patients’ lives. Many people living with schizophrenia have difficulty finding an effective treatment and continue to experience distressing symptoms. With the help of a dedicated treatment team, it is possible for people with schizophrenia to live full lives. New therapeutic options with different mechanisms of action will enable more patients to find an effective and safe treatment regimen. About Karuna Karuna Therapeutics is a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions. At Karuna, we understand there is a need for differentiated and more effective treatments that can help patients navigate the challenges presented by these severe and disabling disorders. Utilizing our extensive knowledge of neuroscience, we are harnessing the untapped potential of the brain in pursuit of novel pathways to develop medicines that make meaningful differences in peoples’ lives. For more information, please visit www.karunatx.com. Forward Looking Statements This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our expectations about the timing of advancing of our planned clinical trials and regulatory filings, our goals to develop and commercialize our product candidates, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to obtain necessary funding, our ability to generate positive clinical trial results for our product candidates, the timing and scope of regulatory approvals, changes in laws and regulations to which we are subject, competitive pressures, risks relating to business interruptions resulting from the coronavirus (COVID-19) pandemic, and other risks set forth under the heading “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. View source version on businesswire.com:https://www.businesswire.com/news/home/20210224006127/en/ CONTACT: Investor Contact: Alexis Smith 518-338-8990 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS INDUSTRY KEYWORD: MENTAL HEALTH HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY SOURCE: Karuna Therapeutics, Inc. Copyright Business Wire 2021. PUB: 02/24/2021 05:09 PM/DISC: 02/24/2021 05:09 PM http://www.businesswire.com/news/home/20210224006127/en Local NewsBusiness Karuna Therapeutics Announces New England Journal of Medicine Publication of Data from EMERGENT-1 Phase 2 Trial Evaluating KarXT in Schizophrenia TAGS Twitter Twitter Facebook Pinterest Facebook By Digital AIM Web Support – April 6, 2021 Pinterest Previous articleArctos NorthStar Acquisition Corp. 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USC women’s volleyball kicks off Pac-12 play on Wednesday, as the team travels crosstown to take on rival UCLA. The Women of Troy take a perfect 12-0 record into Pauley Pavilion and have dropped just two of their 38 sets so far this season.The team is coming off of another impressive tournament showing in Norman, Oklahoma, to cap off its dominant preseason. Wins over Oklahoma and Maryland boosted USC into No. 3 in the nation, and the Women of Troy have rocketed up the rankings after starting at No. 22 less than a month ago.Though the squad is undoubtedly talented, not many were expecting USC to be such a force this season. Head coach Mick Haley admitted that he was also a bit surprised — not that he’s complaining.“We really thought it would take a little bit longer for these young kids to get acclimated,” he said. “But they’re pretty volleyball savvy and they’re competitive.”Conference play, however, will pose a new kind of challenge to the Women of Troy. The players will be pitted against opponents they face year in and year out and who are more aware of their tendencies on the court as a result.“They are going to be familiar with you,” Haley said. “They know your coaching styles; [Pac-12 teams] study each other all the time.”While the Women of Troy have been busy studying the Bruins in preparation for the game, Haley knows the Bruins are aware of his team’s weaknesses as well.“They’ll attack any weaknesses that we have, and they’ll attack them ferociously. It’ll be interesting to see how our kids hold up,” he said.The Women of Troy actually find themselves at an advantage in this regard going into their Pac-12 matchups. Since USC overhauled its system after last season, other teams in the conference will have less tape on the squad’s playing style leading up to a match. Coach Haley hoped this would give his team the edge.“[UCLA] really haven’t played against a USC team that has this kind of speed and this kind of scoring potential,” he said.UCLA will aim to prove Haley wrong on Wednesday night. The No. 13 Bruins have also gotten off to a strong start in their 2015 campaign and have not dropped a match since August. Their last loss came when they fell 0-3 to Loyola Marymount. UCLA responded well to the early season loss, winning its next eight games by a combined score of 24-3.The Bruins will play their first game of the year in the Pauley Pavilion when the Women of Troy visit; they played their first two home games of the season in the John Wooden Center.USC will have extra motivation for Wednesday’s contest, as the Women of Troy fell to the Bruins in both their meetings last year. The Pac-12 opener at the Galen Center finished 0-3, and the team finished its regular season with a 2-3 loss in Westwood.Haley said that he “could not fathom” losing two years in a row to UCLA but was confident that this year’s team would snap the skid.“They have a completely different focus,” he said. “They may be young, but they are certainly hungry.”This 2015 squad looks different from last year’s. At this point in 2014, the Women of Troy limped into their Pac-12 opener against the Bruins having lost three of their last four, and they would go on to start a three-game skid with a loss to UCLA. Now with a new look and newfound confidence, USC will try to turn the tables this season. The game will begin at 7:30 p.m. with TV coverage on the Pac-12 Network.
CLEAR LAKE — For the first time in 40 years, the Clear Lake boys basketball team is in the state tournament as they’ll face West Delaware in a Class 3A quarterfinal later today. The Lions are the only undefeated team in Class 3A but only garnered the fourth seed in the state field. Clear Lake coach Jeremy Ainley says he believes his team is talented enough that they’ll be playing three games this week.Clear Lake will face a West Delaware team that is 17-6 overall and finished in a three-way tie for second in the WaMac Conference-East Division at 12-5. The Hawks are led by 6-foot-7 senior Derek Krogmann, who leads Class 3A in rebounds at 14 per game and is fourth in scoring at 21.8 points per contest. You can hear live and local coverage of the Clear Lake-West Delaware Class 3A state quarterfinal game this afternoon starting at 12:30 with the pre-game, with the tipoff scheduled for 1 o’clock on AM-1490 & 96.7-FM KRIB and online at kribam.com DES MOINES — Drake will be without one of its top players for the Missouri Valley Conference Tournament.Drake overcame the loss of star point guard Nick Norton in the opening moments of league play to earn a share of the Missouri Valley title and now face a similar challenge heading into the conference tournament.Freshman guard D.J. Wilkins will miss the remainder of the season with a broken ankle suffered with nine minutes remaining in Saturday’s win at Missouri State. Wilkins averaged just over 11 points per game and also is second on the team in steals.The Bulldogs are the two seed in the tournament and will play either Illinois State or Evansville on Friday night. === rest of the 3A quarterfinals11:15 — Norwalk (20-4) vs. Ballard (15-9)2:45 — Sergeant Bluff-Luton (20-3) vs. Winterset (16-6)4:30 — Oskaloosa (16-5) vs. Marion (16-5) AMES — The Iowa State women celebrated Senior Night with a 69-49 win over Kansas last night. The Cyclones locked up the second seed in the Big 12 Tournament.ISU coach Bill Fennelly. Picked to finish sixth in the pre-season Fennelly says chemistry allowed the Cyclones to exceed expectations.The Cyclones open the Big 12 Tournament Saturday night in Oklahoma City. === Class 2A quarterfinals Monday and todayBoyden-Hull 61, Iowa City Regina 56South Hamilton 73, Rock Valley 61Van Meter 43, Dike-New Hartford 329:30 — North Linn (23-0) vs. Des Moines Christian (17-6) MASON CITY — The NIACC women now know their opponent for Wednesday night’s Region XI quarterfinal round game. 8th-seed Little Priest Tribal College beat 9th-seed Ellsworth 103-71 last night in the play-in game to the quarterfinal bracket. You can hear the NIACC-Little Priest Region XI quarterfinal women’s game on Wednesday evening at 5:30 on KGLO. The NIACC men will also host Little Priest in the Region XI quarterfinal round tonight at the campus gym starting at 7 o’clock, a game you can also hear on KGLO. FORT MYERS, Fla. (AP) — Jose Berrios will be Minnesota’s opening day starter, the first such assignment for the 24-year-old right-hander. Twins manager Rocco Baldelli made the announcement, with the first game against Cleveland set for March 28. Berrios was the team’s only All-Star last season. Berrios posted a career-best 3.84 ERA last year, his third in the major leagues, with 202 strikeouts in 192 1/3 innings. Berrios will be the youngest opening day starter for the team since Brad Radke in 1997. === 4A quarterfinals tonight6:30 — Cedar Falls (18-3) vs. Sioux City East (21-1)8:15 — North Scott (22-1) vs. Ames (17-4) TODAY:AM-1490/96.7-FM KRIB, kribam.com — 3A boys state quarterfinal — Clear Lake vs. West Delaware — pre-game 12:30, tipoff 1:00AM-1300 KGLO, kgloam.com — Region XI men’s quarterfinal — NIACC vs. Little Priest Tribal College — pre-game 6:45, tipoff 7:00 === Class 1A quarterfinals MondayGrand View Christian 58, Council Bluffs St. Albert 51Montezuma 78, Bishop Garrigan 65Remsen St. Mary’s 58, Clinton Prince of Peace 55Alburnett 55, Sioux Central 54 IOWA CITY, Iowa (AP) — Iowa senior Megan Gustafson has been named the Big Ten player of the year, becoming the first Hawkeye to win the award twice. Gustafson was tabbed for the honor in a vote by the league’s coaches and media members. Gustafson averaged 28.4 points, 13.8 rebounds, and shot 68.7 percent from the field in Big Ten games this season. UNDATED (AP) — Jim Delany will step down as commissioner of the Big Ten Conference in June 2020. Over three decades, the 71-year-old Delany helped the Big Ten grow to 14 schools, launched the first conference television network and helped construct the College Football Playoff. He also protected the league’s relationship with the Rose Bowl. Big Ten revenues soared under his leadership and he became one of the most powerful figures in college sports.
Submitted by Hartley JewelersWhen Joe Lozito began his quest for the perfect engagement ring for his fiancée, Jen O’Neal, he had an inkling of where to begin, but no idea about the long journey the ring would take, nor about the journey the stones had already taken.Jen sums up the ring’s journey: “The stone came from my parents, the diamonds from his parents, and it was made by a jeweler in Washington.”The stories of the stones begin in New York and Thailand. Let’s start with the New York stones. Joe grew up in New York, the son of opera singers. Joe’s mother, Adele, died when he was 15, and her wedding ring was safely set aside. Because the ring had been stored away for many years, Joe had forgotten what it looked like. At Joe’s request, his father, Art, showed him the ring, which had a marquise stone and four small diamonds. With his father’s blessing, Joe took the four small diamonds, and his brother received the larger stone.When Joe asked Jen’s dad for his blessing to marry his daughter, Jen’s mom offered the center stone of her ring, a star sapphire. Jen, who grew up in Olympia, fondly remembers her mom wearing the ring, and the sapphire is even more meaningful since it is Jen’s birthstone.Joe wanted the heirloom stones – four small diamonds and a star sapphire – to be made into a contemporary engagement ring. Jen’s family had long shopped at Hartley Jewelers in Olympia, so Joe talked to Rick Hartley about designing Jen’s ring.The design process started with making two-dimensional sketches. When the ring design drawings satisfied Joe, the goldsmith, DeAnn Hamilton, created a wax mold. Joe approved each step of the process through photographs because he was in New York. When the design was finalized, a casting mold was made. After several more steps in the process, finally, the ring was completed.“It’s an extensive process,” explains DeAnn. “Once the custom ring is created, we destroy the mold, so it’s truly one-of-a-kind.”The star sapphire had come from Thailand when Jen’s father served in the military and went to Vietnam during the war, about 1968–69. “It was an awful place that he didn’t want to be,” says Jen. “My mother didn’t want him to go.” One day he went to Thailand with a Thai friend who took him to a jewelry store. There Jen’s dad bought the star sapphire stone for his wife in Olympia. “He brought something beautiful back from such an ugly time in their lives,” Jen says.During the first four months of Joe and Jen’s engagement, Jen wore a green plastic engagement ring, a nod to the couple’s interest in science fiction. She was patient because she knew a real ring was in production.About designing a contemporary ring, Rick Hartley says, “We get to blend a heritage from two different families into an heirloom ring that is a daily part of their lives. They are wearing part of their histories. We help them create something that’s unique and different.”When Joe finally had the ring in his hands in New York, he took Jen to a waterfront town with crab houses and seafood shacks – a town that reminds her of Olympia – to give her the ring.Joe and Jen were married on Oct. 22 on Long Island. They incorporated other family heirlooms and vintage items, including a cake knife and old books, into their wedding décor.They live in New Jersey and work in New York City.By Paula Rudberg Lowe. Reprinted with permission from original author, Wedding & Events Magazine, summer 2012. Photos by Photo by Jennifer Strader Photography. Facebook7Tweet0Pin0