Vocal Cord Dysfunction

Company Funded by Novo Holdings A/S, RA Capital, Mass General Brigham Ventures, Expands Syndicate With Financing from Janus Henderson InvestorsLead Program, CSB-001, a Topical Ocular Biologic Solution of dHGF, Targets the Complete Healing of the Cornea Surface in Eyes with Neurotrophic Keratopathy (NK)Topline Data Expected in 1H24 From Late-Stage Study of CSB-001 in NKLeadership Team, with an Extensive Track Record and Deep Expertise in Ophthalmology Drug Development, Commercialization, and Partnerships, Brings Company from Pre-IND to Pivotal Data in Four Years JERSEY CITY, N.J., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Claris Bio, a late-clinical stage biotechnology company focusing on corneal disease therapies, today unveiled the company and its lead program, with a total of $57 million invested from Series A investors Novo Holdings A/S, RA Capital and Mass General Brigham Ventures and recent investor, Janus Henderson Investors. Claris, initially funded in 2020, is developing recombinant human variant hepatocyte growth factor, dHGF, to accelerate and improve the quality of corneal healing in patients with corneal eye disease. Its lead program, CSB-001 Ophthalmic Solution 0.1% (oremepermin-α), brings a topical ocular biologic solution of dHGF, a molecule with the potential to restore structural and functional corneal integrity, to eyes with neurotrophic keratopathy (NK). Oremepermin-α is epitheliotropic, neurotrophic, anti-inflammatory, and anti-fibrotic, suggesting it could be an efficacious and safe option to treat many current unmet needs in diseases of the cornea. Claris expects to complete enrollment in its late-stage multi-center, randomized, double-masked, vehicle-controlled, parallel-group study, with a data readout expected in 1H2024. Beyond NK, Claris’ strategy is to create a pipeline by developing oremepermin-α across multiple ophthalmic diseases, greatly expanding the patient population that can benefit from its activity. Additional indications of interest that are being actively pursued by Claris, supported by preclinical and clinical data, include limbal stem cell deficiency and pre-existing corneal scar. Future potential indications include corneal injury, corneal ulcers, chemical burns, and persistent epithelial defects. “Our vision is to lead the way in corneal therapy by developing oremepermin-α into a pipeline that addresses the high unmet need in corneal disease. We are honored to have such a strong group of investors, as we approach a pivotal inflection point in our company’s growth,” said Claris Bio Founding CEO Clarke Atwell. “Topical oremepermin-α therapy has the potential to significantly impact several significant conditions of the cornea, with the potential to improve patients’ lives.” In addition to Mr. Atwell, the Claris leadership team includes CMO Susan Orr, OD, and Chief Business Officer Henry Rath. Scientific cofounders include Dr. Reza Dana, MD, MSc, MPH, and Dr. Sunil Chauhan, DVM, PhD., both from the Massachusetts Eye and Ear and the Harvard Medical School Department of Ophthalmology. “Claris Bio is developing what has the potential to be the new standard of care for numerous corneal diseases,” said Agustin Mohedas, Ph.D., Portfolio Manager, Janus Henderson Investors. “We are excited to be part of the next chapter in the company’s growth.” Neurotrophic keratopathy, or NK, is a rare chronic degenerative disease caused by impairment of corneal sensory innervation. NK is characterized by decreased or absent corneal sensation (nerve damage), leading to epithelial breakdown, persistent wounds, scarring and ultimately the development of ulceration, melting, and perforation, and it is estimated that there over 100,000 patients with NK in the US. About Oremepermin Alfa Oremepermin alfa is the International Nonproprietary Name of the five amino acid-deleted variant of hepatocyte growth factor (dHGF). Recombinant human dHGF was originated and is currently being developed by Kringle Pharma, Inc. a late-clinical stage biopharmaceutical company, for the treatment of incurable diseases such as acute spinal cord injury and vocal fold scar. Claris and Kringle formed a partnership in 2020 where Claris secured all rights to oremepermin alfa in ophthalmic indications worldwide. About Claris Bio Claris Bio, based in Jersey City, NJ, was founded by a group of experienced biopharma industry executives and experts in ophthalmology. The company’s foundational intellectual property is based on work done at the Massachusetts Eye and Ear Infirmary by Dr. Reza Dana, MD, MSc, MPH, Claes Dohlman Chair in Ophthalmology, Harvard Medical School and Senior Scientist and Director of Cornea at Mass Eye and Ear and Dr. Sunil Chauhan, DVM, PhD, Principal Investigator and Associate Professor, Mass Eye and Ear, Harvard Medical School. Claris’ lead program, CSB-001 Ophthalmic Solution 0.1%, brings a topical ocular biologic solution of oremepermin-α, a molecule with the potential to restore structural and functional corneal integrity, to eyes with neurotrophic keratopathy (NK). For more information about Claris, please visit www.clarisbio.com. MEDIA CONTACTS: Dana Kahn Cooper(732) 239-6664dana@dcoopercommunications.com Eliza Schleifstein(917) 763-8106eliza@schleifsteinpr.com

TUESDAY, Aug. 1, 2023 -- Pediatricians have suspected it for years, and now a new study may be proving them right: Cold air really can help ease children's croup symptoms. Croup is a common childhood illness that usually starts as an ordinary cold. It arises when the infection causes swelling around the voice box (larynx) and wind pipe (trachea), leading to some distinctive croup symptoms: a cough that sounds like a seal's bark and a high-pitched "creaky" or whistling noise when a child inhales (what doctors call stridor). Fortunately, most cases of croup are mild. And pediatricians have long told parents they can try some old-fashioned tricks for milder croup symptoms: running a hot shower and standing with their child in the steamy bathroom; standing in front of an open refrigerator freezer, or wrapping their child in blankets and going outside in the chilly air for a bit. "The common denominator there is the moist air," said Dr. Mike Patrick , an emergency medicine physician at Nationwide Children's Hospital in Columbus, Ohio. "Indoor air, especially in the winter, is dry." He said pediatricians were giving that advice back when he was a resident almost 30 years ago. There is a basis for it, Patrick and other pediatricians said. There is a "classic" croup scenario where a child develops worsening symptoms at night and worried parents rush the child to the ER. "But by the time they get there, the symptoms are getting better," said Dr. Matthew Harris , an emergency physician at Cohen Children's Medical Center in New York. It seems that just a short time in the cool air can be helpful, Harris said. A new study, published online Aug. 1 in Pediatrics, put that belief to the test. The research was conducted by Dr. Johan Siebert and colleagues at Geneva Children's Hospital in Switzerland. They recruited families who were bringing their baby or young child to the ER because of croup symptoms. If the symptoms were mild to moderate, the families were randomly assigned to one of two groups: one where children were given the oral anti-inflammatory drug dexamethasone and then spent 30 minutes outside in the chilly air; and one where kids received dexamethasone and stayed inside the ER. None of the children had severe symptoms, such as persistent stridor, even at rest, or difficulty breathing. In those cases, it's standard to give inhaled epinephrine to open up the airways quickly, Patrick said. Overall, the study found, cold air was helpful for at least some kids. Of 59 children exposed to outdoor air, 49% had a substantial improvement in symptoms by the 30-minute mark. That compared with about 24% of 59 children who stayed indoors. However, the findings do not mean that ERs should start sending families out into the ambulance bay to manage a child's croup symptoms. For the study's purposes, the ER served as a controlled setting to observe the effects of cold air exposure, Harris and Patrick said. Instead, they said, pediatricians can see the findings as evidence for some benefit of the practice. "What's cool about this study is, it brings this into the realm of evidence, and not just anecdote," Patrick said. Dr. Joanne Nazif , of Children's Hospital at Montefiore in New York City, agreed that the study offers "some evidence" in support of cold air. But she also stressed that the researchers tested it in combination with dexamethasone -- not as a stand-alone. And cold air did not always help, Nazif noted. If parents have any worry about their child's breathing, Nazif said, they should seek care. But, she added, "you might want to crack the car window open on the way to the ER." Sources Michael Patrick, MD, emergency medicine physician, Nationwide Children's Hospital, assistant professor, clinical pediatrics, Ohio State University College of Medicine, Columbus, Ohio Matthew Isaac Harris, MD, emergency physician, Cohen Children's Medical Center, New York City Joanne M. Nazif, MD, attending physician, Children's Hospital at Montefiore, assistant professor, clinical pediatrics, Albert Einstein College of Medicine, New York City Pediatrics, September 2023 Posted August 2023

SATURDAY, June 3, 2023 -- Summer is here and so, too, is swimming season. As fun as a pool can be, it’s also a major safety risk if you don’t take the appropriate precautions. An expert from Huntington Health, an affiliate of Cedars-Sinai in Los Angeles, offers some tips for a safe pool season. “If children or non-experienced swimmers will be in the pool, it's very important to have adult supervision. I think asking another child to watch after their sibling, for example, is not adequate,” said Dr. Amal Obaid-Schmid , medical director of trauma services at Huntington Health. “You need a supervisor who's an adult, who is not distracted with their cellphone, or a phone call inside the house, or a conversation with another adult, really taking that role very seriously. Not letting your eye off the child is huge because drowning can happen in an instant,” she said in a Cedars-Sinai news release. More children aged 1 to 4 die from drowning than any other cause of death, according to the U.S. Centers for Disease Control and Prevention. Pool owners should be sure to have a fence at least four feet high around their pool, Obaid-Schmid advised. Keep a variety of flotation devices in and around the pool — a life jacket plus pool noodles or a paddle board — so that a drowning person has something to grab to help them get out of the pool quickly. Have a cellphone in the pool area so that you can call for help immediately. Adults should also learn basic CPR. The steps are: Place the person on their back and gently lift their chin and tilt their head back. Pinch their nose and place your mouth tightly over their mouth and administer two short breaths. Then start chest compressions, placing one hand over the other and placing them over the patient’s breastbone and administering 30 compressions. Start again with the two breaths and compressions until the patient starts breathing. Call for help and start administering CPR as quickly as possible. Drowning isn’t the only danger with pools. Emergency department staff sometimes see significant head injuries and spinal cord injuries that come from reckless diving, Obaid-Schmid said. This happens more among teenagers and young adults. Prevent this by making sure people are only using existing diving boards that are designed to dive into deep water. Do not dive head first into shallow water or attempt to dive from a roof or patio. Alcohol and swimming don’t mix, increasing the risk of drowning by 37-fold. Another risk is a condition called “dry drowning.” This happens after a near-drowning event in which water gets into someone’s lungs and causes a laryngospasm. That means the airway is closed off and can't provide someone with enough oxygen. This can happen from several hours to 24 hours after the near-drowning incident. The signs may be subtle. They can include coughing, vomiting, not being able to talk or just not appearing well. Call 911 or go to the emergency department right away. This is very rare, but can be fatal. Sources Cedars-Sinai, news release, May 31, 2023 Posted June 2023