Kringle Pharma, Inc.

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

Los Angeles, USA , April 21, 2021 (GLOBE NEWSWIRE) -- Spinal Cord Injury Clinical Trials Review: A Multitude of Emerging Drugs for Better Treatment Around 40+ notable companies such as Kringle Pharma, Eusol Biotech, Pharmicell, Pharmazz, AbbVie, Acorda Therapeutics, Geron Corporation, ReNetX Bio, GNT Pharma, AlaMab Therapeutics, Mitsubishi Tanabe Pharma, Kancera, Olatec Therapeutics, Scholar Rock, AXONIS Therapeutics, K-STEMCELL, Athersys, AmKor Pharma, Histocell, Lineage Cell Therapeutics, and others have their Spinal Cord Injury drug candidates in the pipeline to influence treatment scenario. DelveInsight’s “Spinal Cord Injury Pipeline Insight” report provides comprehensive insights about 40+companies and 40+ pipeline drugs in the Spinal Cord Injury pipeline landscapes. It comprises Spinal Cord Injury pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Spinal Cord Injury therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Spinal Cord Injury pipeline products. Some of the key takeaways of the Spinal Cord Injury Pipeline Report Get an overview of pipeline landscape @ Spinal Cord Injury Clinical Trials Analysis Spinal Cord Injury is traumatic damage or nerves at the end of the spinal canal. This affects the conduction of sensory and motor signals across the site of the lesion. This disease is a debilitating neurological condition with a tremendous socio-economic impact on affected individuals and the health care system. Spinal Cord Injuries patients require multidisciplinary care management to achieve optimal health outcomes. Treatments for chronic Spinal Cord Injury focus on avoiding or improving distinct pathophysiological mechanisms, such as glial scar formation, demyelination, and astrogliosis. Treatment strategies for acute Spinal Cord Injury are limited to preventing further damage; the therapeutic approach for chronic Spinal Cord Injury focuses on promoting neuronal regeneration and treating accompanying symptoms of chronic complications. Spinal Cord Injury Emerging Drugs HGF (KP-100IT) protects neurons, promotes axons’ extension, and can be developed as a potential treatment for Spinal Cord Injury. It is currently in Phase III and is produced by Kringle Pharma. Research and Development Phase III NCT04475224: In July 2020, Kringle Pharma initiated A Non-randomized, Multicenter, and Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects with Acute Spinal Cord Injury. This study is a non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor) formulation for intrathecal injection, in subjects with acute spinal cord injury. The trial is expected to get completed by September 2022 with expected 25 enrolled participants. Results: Primary endpoints in Phase I/II, the safety and tolerability of HGF administration to acute Spinal Cord Injury patients, were confirmed. Although there was no significant difference in the change in ASIA motor score from baseline at week 24, which was used as the primary endpoint of efficacy, the HGF-treated group showed a consistent functional recovery trend throughout the 6-month observation period compared with the placebo group. Moreover, the two groups significantly differed about the change in the ASIA motor score from baseline at week 20, which was the secondary endpoint of efficacy. Thus, the proof of concept (POC) for HGF treatment in Acute Spinal Cord Injury was established. ES135 is a recombinant human acidic fibroblast growth factor (rhFGF1) with 135 amino acids. ES135 promote neurite outgrowth. The sequence of ES135 has been patented in Taiwan, the EU, China and the United States. ES135 is undergoing a multi-centre, double-blind, randomised, placebo-control study as the pivotal Phase 3 clinical trial for Spinal Cord Injury. For further information, refer to the detailed report @ Spinal Cord Injury Pipeline Therapeutics Scope of Spinal Cord Injury Pipeline Drug Insight Key Questions regarding Current Spinal Cord Injury Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customised pipeline report @ Spinal Cord Injury Drugs Pipeline Report Related Reports DelveInsight's Spinal Cord Injury (SCI)- Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight's Spinal Cord Injury (SCI) - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of the disease. DelveInsight's Chronic Spinal Cord Injury - Epidemiology Forecast 2030 report delivers an in-depth understanding of the disease, historical, and forecasted epidemiology of Chronic Spinal Cord Injury in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. DelveInsight' s Spinal Fusion - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight' s Spinal Muscular Atrophy (SMA) - Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and an in-depth understanding of historical and forecasted epidemiology. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.