Idiopathic Pulmonary Fibrosis

STOCKHOLM, SE / ACCESSWIRE / March 19, 2024 / Vicore Pharma Holding (STO:VICO) AlmeeTM is the first digital therapy to address anxiety and quality of life in patients living with pulmonary fibrosis (PF). AlmeeTM has shown effectiveness in reducing anxiety symptoms and improving health-related quality of life in the COMPANION study as reported earlier this year, driving a 2.7-point increase in GAD-7 score and a 4.4 improvement in KBILD score Stockholm, March 19, 2024 - Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced FDA Breakthrough Device Designation status for AlmeeTM, a 9-week digital cognitive behavioral therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF. The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy. Almee is a patient-facing tool based on CBT principles accessed via a smartphone or tablet. The COMPANION study on Almee demonstrated a 2.7-point improvement over control in GAD-7 (generalized anxiety disorder scale) and a 4.4 improvement in KBILD (King's Brief Interstitial Lung Disease) total score for quality of life. PF affects approximately 250,000 people in the United States[1], with increasing incidence[2]. Currently available therapies only slow the progression of this devastating and fatal disease. The physical burden of PF drives psychological impact with studies showing that 60% of patients with PF report having anxiety[3]. "Breakthrough designation sets Almee apart as an innovative and effective tool for PF patients, and it supports our ambition to help patients with pulmonary fibrosis by improving quality of life," said Ahmed Mousa, Chief Executive Officer of Vicore . Vicore plans to present Almee and the COMPANION study at a pulmonology conference in 2024. The company is seeking to advance Almee in partnership with the developers of approved and late-stage molecular therapies for the treatment of pulmonary fibrosis. "Almee represents the future of healthcare and is poised to deliver significant patient impact as an example of innovation in digital-molecular combination therapies," said Jessica Shull, PhD, Director of Digital Health at Vicore. Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics. This information was submitted for publication on March 19, 2024, at 08:00 CET. About AlmeeTM Almee was developed in collaboration with Alex Therapeutics and is a software built for patients to be used on smartphones or tablets. The application includes psychological exercises based on CBT principles, and other interactive methodologies designed to increase beneficial actions and thoughts and improve anxiety and quality of life. About the COMPANION trial The trial was an open randomized study in 110 patients who were not on cognitive behavioral therapy but could be on anxiolytic or anti-depressant therapy or both. Positive topline data in the study was reported in January 2024. The measurements were focused on anxiety using validated instruments like GAD-7, and on quality of life using the K-BILD questionnaire. The study was analyzed using predefined criteria and analysis methods. About Vicore Pharma Holding AB (publ) Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see . About Alex Therapeutics Alex Therapeutics, a digital health company, partners with pharmaceutical companies to help patients with disease and treatment-specific challenges through clinically validated apps. With its proven, scalable technology platform, as well as expertise in patient-centric design and evidence-based behavior change, Alex Therapeutics treats patients and supports healthcare professionals globally. Alex Therapeutics, alongside its partners, has extensive experience in multi-jurisdiction Software-as-a-Medical-Device (SaMD) regulatory processes, including CE and FDA approval, as well as clinical evidence generation for SaMDs. For more information, visit [1] [2] Pergolizzi JV Jr, LeQuang JA, Varrassi M, Breve F, Magnusson P, Varrassi G. What Do We Need to Know About Rising Rates of Idiopathic Pulmonary Fibrosis? A Narrative Review and Update. Adv Ther. 2023 Apr;40(4):1334-1346. doi: 10.1007/s12325-022-02395-9. Epub 2023 Jan 24. PMID: 36692679; PMCID: PMC9872080. [3] van Manen MJ, Kreuter M, van den Blink B, Oltmanns U, Palmowski K, Brunnemer E, et al. What patients with pulmonary fibrosis and their partners think: a live, educative survey in the Netherlands and Germany. ERJ Open Res. 2017;3:00065-2016 Attachments Vicore Announces FDA Breakthrough Device Designation for AlmeeTM, a Digital Therapy for Patients with Pulmonary Fibrosis SOURCE: Vicore Pharma Holding View the original press release on accesswire.com

Johnson & Johnson is a partner on Contineum Therapeutics’ most advanced program, which is currently in mid-stage clinical testing for multiple sclerosis. As that research continues and Contineum plans to advance the development of its wholly owned assets, the biotech is moving forward with plans for an IPO. Contineum, which traces its origins to a startup creation engine of venture capital firm Versant Ventures, filed its IPO paperwork with the Securities and Exchange Commission late Friday. The company has not yet set any financial terms for its planned stock market debut, but IPO research firm Renaissance Capital said the offering could reach up to $150 million. The San Diego-based biotech has applied for a Nasdaq listing under the stock symbol “CTNM.” Contineum’s most advanced program is PIPE-307, a small molecule designed to selectively block the M1R receptor. This approach has potential applications in the treatment of multiple sclerosis and depression. Contineum has reported Phase 1 results showed the drug candidate was well tolerated across all doses and showed no dose-related effects on cognitive function. Nearly a year ago, J&J licensed global rights to PIPE-307 for all potential indications. However, the deal still permits Contineum to develop this molecule for relapsing and remitting forms of MS by conducting a Phase 2 study. That clinical trial is ongoing. A Phase 1 test of this molecule in depression is also underway as part of the J&J collaboration. The lead wholly owned Contineum asset is PIPE-791, a program currently in Phase 1 testing. This small molecule is designed to block LPA1, a receptor whose activation is associated with the development of organ scarring called fibrosis. The company believes the molecule’s ability to block LPA1 could treat idiopathic pulmonary fibrosis (IPF), a chronic lung disorder with few available treatments. MS is another potential application for PIPE-791. Levels of LPA, a pro-inflammatory protein, are elevated in the blood and cerebrospinal fluid of MS patients, which may contribute to the progression of this disease, Contineum said in the filing. One key feature of this molecule is its ability to penetrate the brain. In preclinical research, the company said blocking the LPA1 receptor reduces neuroinflammation and promotes remyelination, the formation of new myelin sheaths on axons that have lost this protective layer. Contineum plans to submit an application this year seeking permission in the U.K. for an open-label Phase 1b test of PIPE-791 to assess the molecule’s ability to bind to receptors in the lungs and brain as measured by PET imaging. This study will inform dose selection for planned future Phase 2 tests of the molecule in IPF and progressive MS. The pipeline also includes CTX-343, an LPA1 receptor-blocking molecule that does not cross the blood brain barrier. This capability could provide Contineum more options for its drug portfolio, the company said. CTX-343 is currently preclinical. Contineum traces its roots to Inception Sciences, one of the drug discovery engine of Versant Ventures. Inception and Roche had collaborated to discover and develop small molecules that promote remyelination of nerve fibers damaged as MS progresses. After Roche acquired this neuroscience program for an undisclosed sum in 2018, Versant launched Pipeline Therapeutics, a startup led by the same team that worked on the program that Roche acquired. Versant said Pipeline would focus on developing “next-generation neurodegenerative therapies.” In late 2023, Pipeline changed its name to Contineum Therapeutics. Contineum has raised about $194 million in financing, according to the filing. The J&J alliance paid $50 million upfront and could pay out up to $1 billion tied to the achievement of milestones. Versant is Contineum’s largest shareholder with a 32.2% pre-IPO stake; Johnson & Johnson’s stake is 10.1%. The company’s most recent financing was a 2021 Series C round that raised $80 million. As of the end of 2023, Contineum reported a $15.5 million cash position along with $109.6 million in marketable securities. That capital, combined with the IPO proceeds, will go toward continued clinical development of the LPA1 receptor antagonist, including the completion of Phase 1b testing. An unspecified amount of additional cash will go toward planned Phase 2 tests in IPF and progressive MS. Contineum also plans to use the IPO proceeds to complete Phase 2 testing of its J&J-partnered molecule in relapsing and remitting forms of MS. Image: Getty Images

Boundless Bio and now Contineum Therapeutics have kept the IPO market ticking over in March. The biotech IPO class of 2024 could be getting another member. Contineum Therapeutics is the latest company to test the waters, filing paperwork to raise money for phase 2 clinical trials of its lead prospect and a Johnson & Johnson-partnered molecule. Contineum, a biotech previously called Pipeline Therapeutics, wants the money to fund phase 1b and 2 trials of its lead drug candidate in idiopathic pulmonary fibrosis (IPF) and progressive multiple sclerosis (MS). The molecule, PIPE-791, is designed to inhibit LPA1, a receptor that studies suggest may drive scarring in IPF and promote neuroinflammation and limit remyelination in MS. Based on preclinical studies and tests in healthy volunteers, Contineum believes once-daily doses of the molecule could treat IPF. The schedule would set PIPE-791 apart from existing IPF therapies. Boehringer Ingelheim’s Ofev and Roche’s Esbriet are, respectively, taken two and three times a day. Other drug developers have hit on the idea of targeting LPA1 to treat IPF. Bristol Myers Squibb picked up a LPA1 candidate in 2011 through its $325 million acquisition of Amira Pharmaceuticals, a biotech at which Contineum founder and chief scientific officer Daniel Lorrain, Ph.D., worked. BMS posted phase 2 data on the LPA1 antagonist BMS-986278 last year. Amgen acquired a phase 2 LPA1 drug, now called AMG 670, as part of the Horizon Therapeutics buyout. AbbVie entered the LPA1 space in 2022 by paying $255 million for DJS Antibodies. Structure Therapeutics has also discovered inhibitors of the receptor. The progressive MS space is less competitive. Contineum contends PIPE-791 is the only brain-penetrant LPA1 receptor antagonist in clinical development in the indication. Progressive MS has proven a tougher nut to crack than other forms of the disease, with Contineum noting that studies of would-be rivals have generated “almost uniformly disappointing results.” But the mechanism of PIPE-791 suggests it may be able to improve outcomes by addressing chronic neuroinflammation and demyelination. Contineum has earmarked another chunk of the anticipated IPO haul for a phase 2 trial of PIPE-307, the drug candidate covered by the J&J agreement, in relapsing-remitting MS. The terms of the J&J deal require Contineum to run a phase 2 trial in the indication. Enrollment in the study began in November.  Interest in developing PIPE-307 in relapsing-remitting MS, a setting where effective immune-modulating treatments exist, is underpinned by evidence that the M1R inhibitor may be the molecule that finally achieves direct promotion of remyelination. Decades of failed programs have made remyelination the holy grail of MS drug development.  Contineum had run up an accumulated deficit of $75 million pursuing remyelination and other projects by the end of last year. The spending left the biotech with $125 million in cash, cash equivalents and marketable securities from its private financing rounds, which include an $80 million series C it closed in 2021. The biotech’s identification of public investors as the people to bankroll the next steps in its evolution keeps the IPO stream trickling along. While the pace of new listings slowed after a flurry early in the year, Boundless Bio and now Contineum have kept the IPO market ticking over in March.