Acute Disease

NORFOLK, Va.--( BUSINESS WIRE )--ReAlta Life Sciences, Inc. ("ReAlta" or the “Company”), a clinical-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, today announced that the first patient has been dosed in its Phase 2 study of RLS-0071, the Company’s lead therapeutic candidate, for the treatment of hospitalized patients with moderate to very severe steroid-refractory acute graft-versus-host disease (aGvHD), a serious and often fatal complication following hematopoietic stem cell transplantation. “Hematopoietic stem cell transplantation is one of the most impactful treatments available for people with cancer, autoimmune disease, sickle cell disease and other life-threatening disorders. However, the procedure can quickly turn into a severe and life-threatening condition for those who are affected by acute graft-versus-host disease in which the transplanted immune cells attack the patient, leading to severe inflammation and tissue damage,” said ReAlta Chief Medical Officer Kenji Cunnion, MD, MPH. “We believe that RLS-0071 has the potential to be a powerful new tool to improve outcomes for individuals with this serious complication of transplantation. We aim to leverage RLS-0071's unique dual mechanism-of-action (MOA) to inhibit unwanted inflammatory side-effects from the donor cells. We are committed to advancing this clinical program on behalf of patients facing steroid-refractory aGvHD.” Patients with aGvHD who do not respond to standard steroid treatments have limited therapeutic options and face severe inflammation, tissue damage and a high risk of mortality. Each year, approximately 4,000 patients develop steroid-refractory aGvHD within the U.S., EU and Japan. RLS-0071, an investigational medicine based on the Company’s novel EPICC peptide platform, seeks to address this unmet medical need by capitalizing on its unique dual-targeting MOA to modulate both the complement and innate inflammatory pathways, offering a new hope for patients with this devastating condition. RLS-0071 was recently granted Orphan Drug Designation and Fast Track Designation for the treatment of steroid-refractory aGvHD by the U.S. Food and Drug Administration (FDA). The Company is also currently conducting Phase 2 clinical trials of RLS-0071 in newborns with hypoxic ischemic encephalopathy (HIE) ( NCT05778188 ) and hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease (AE-COPD) ( NCT06175065 ). About the Study The Phase 2 study ( NCT06343792 ) is an open-label, prospective, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing and efficacy of RLS-0071 for the secondary treatment of acute graft-versus-host disease (aGvHD) in hospitalized patients who are steroid-refractory. Participants will receive RLS-0071 at their assigned dose level(s) for 7 or 14 days as either a monotherapy or concurrent with the standard-of-care treatment, ruxolitinib. Primary outcomes measures include safety and overall response rate. About ReAlta Life Sciences ReAlta Life Sciences, Inc. is a clinical mid-stage biopharmaceutical company dedicated to saving lives by rebalancing the inflammatory response to address life threatening rare and acute inflammatory diseases. The Company’s EPICC peptide platform is based on discoveries related to the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system – a trait unique among viruses. By inhibiting activation of the complement cascade and two key neutrophil-driven mechanisms of inflammation and host tissue destruction - myeloperoxidase (MPO) and neutrophil extracellular traps (NETs), ReAlta’s therapeutic peptides leverage the dual-targeting mechanisms of this human enteric virus – and its millions of years of evolutionary adaptations – to modulate both complement and innate inflammatory pathways. The Company’s pipeline is led by RLS-0071, which has received both Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic ischemic encephalopathy (HIE), a devastating disease that causes brain damage in oxygen-deprived newborns and is a leading cause of cerebral palsy; Orphan Drug Designation and Fast Track Designation by the FDA for the treatment of acute graft-versus-host disease (aGvHD), a disease associated with bone marrow and stem cell transplants whereby transplanted white blood cells attack the new host in an inflammatory response; and IND clearance by the FDA for the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), an inflammatory lung disease characterized by progressive airflow limitations and tissue destruction that makes it challenging for patients to breathe. The company launched in 2018 and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For more information, please visit www.realtalifesciences.com .

HUDSON, Wis.--( BUSINESS WIRE )--Molex, a parent to Phillips Medisize, a leader in the design, engineering and manufacturing of pharmaceutical drug delivery, in vitro diagnostic and medtech devices, announced that, through its affiliate Molex Asia Holdings LTD., it has signed an agreement to purchase Vectura Group Limited (Vectura) from Vectura Fertin Pharma Inc., a subsidiary of Philip Morris International (PMI) (NYSE: PM). Vectura is a leader in inhalation drug device design and formulation, based in Chippenham, United Kingdom. “Combining the strengths of Phillips Medisize and Vectura will enhance our ability to deliver a broader portfolio of inhalation combination drug devices and solutions to our pharmaceutical customers and support our mission to help people live healthier, more productive lives,” said Paul Chaffin, President of Phillips Medisize. “With our global reach, manufacturing scale, and engineering expertise, Phillips Medisize is uniquely positioned to help Vectura in developing innovative new products for their customers, ultimately benefiting people who suffer with chronic and acute diseases such as asthma and COPD.” Vectura brings to Phillips Medisize its unique inhalation expertise that includes formulation and device development for dry powder inhalers (DPI), pressurized metered dose inhalers (pMDI), nasal and nebulizer products for small molecules, biologics, complex combinations and generic products. The company also offers pharmaceutical analysis, process development, technical transfer, clinical trial supplies and regulatory services. Phillips Medisize is a global company that designs, engineers and manufactures products for the pharmaceutical and broader healthcare industry. The company’s 6,000+ employees collaborate with customers at 29 sites located throughout North America, Europe and Asia. Being part of Molex also allows the business to leverage market leading capabilities across a range of specialty electronics and optical fiber applications for the medical industry. “The acquisition of Vectura is the latest step in building an industry-leading capability in medical. It also demonstrates Molex’s commitment to acquiring opportunities to better serve market needs across our portfolio,” said Joe Nelligan, CEO of Molex, which acquired Phillips Medisize in 2016 to build a scale healthcare business. “We are excited by the significant growth potential that comes with a wider range of formulation, device design, combination product development and manufacturing services to support the increasing need for inhalation therapies. We look forward to welcoming the Vectura team, who brings a celebrated reputation of inhalation expertise and experience.” The acquisition is expected to close by the end of 2024, subject to regulatory approvals and other customary closing conditions. About Phillips Medisize Phillips Medisize, a Molex company, collaborates with leading pharmaceutical, medical technology and in vitro diagnostic companies to design, engineer and manufacture life-saving innovations. A contract development and manufacturing organization (CDMO), Phillips Medisize leverages its 60 years of expertise and globally renowned capabilities to deliver products and solutions that annually help millions of patients, healthcare professionals and individuals live healthier, more productive lives. For more information, visit www.phillipsmedisize.com . About Molex Molex is a global electronics leader committed to making the world a better, more-connected place . With a presence in more than 40 countries, Molex enables transformative technology innovation in the automotive, data center, industrial automation, healthcare, 5G, cloud and consumer device industries. Through trusted customer and industry relationships, unrivaled engineering expertise, and product quality and reliability, Molex realizes the infinite potential of Creating Connections for Life . For more information, visit www.molex.com .

Boehringer Ingelheim reported ​ this week that its phase 3 Fibroneer-IPF trial had met its primary endpoint of an improvement in Forced Vital Capacity (FVC), a measure of lung capacity, versus placebo. “This is the first idiopathic pulmonary fibrosis phase-3-trial in a decade to meet its primary endpoint,” said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim, in a press statement. “Today’s announcement represents the next step in our long history in the research of this disease. idiopathic pulmonary fibrosis has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases.” The company is presenting full efficacy and safety data from this trial in early 2025 so the statement this week only included limited data. For example, Boehringer stated that the primary endpoint of the trial –a better FVC score at 52 weeks than placebo– was met, but did not share specific figures. It also did not share information on the secondary endpoint of the study –the time to the first occurrence of a composite endpoint including a combination of: time to first acute disease exacerbation, first hospitalization for a respiratory cause, or death. Nerandomilast, an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B), is also being tested in a second phase 3 trial for treatment of progressive fibrosing interstitial lung diseases. Meeting an unmet need Idiopathic pulmonary fibrosis is estimated to affect between 20-80 people per 100,000 around the world. It is a degenerative condition characterized by the build up of scarring and fibrosis in the lung tissue over time and a gradual decline in lung function. After diagnosis it has an average 5-year survival rate of 20-40%. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Two medications for this condition have been approved by the FDA, a tyrosine kinase inhibitor called Ofev (nintedanib), also developed by Boehringer, was approved in 2014 and Roche’s Esbriet (pirfenidone) a pyridone drug that blocks substances that cause fibrosis as also given FDA approval in 2014. Both have been found to delay lung-function decline and death significantly but are only temporary fixes and there is still a significant need in this patient group. Nerandomilast (previously known as BI1015550) received ​ FDA breakthrough designation in 2022 for the treatment of idiopathic pulmonary fibrosis. This designation allows faster drug development and is only granted if developers can provide good early evidence that their candidate therapy is likely to be a big improvement over currently available treatment options. There are other new drugs for idiopathic pulmonary fibrosis in development, but most of the other candidate therapies are currently at phase 2 or earlier. For example, Vicore Pharma, Bridge Therapeutics and Pliant Therapeutics all have candidates that have reached phase 2. Targeting PDE4 allows Boehringer to trigger both antifibrotic and anti-inflammatory effects with nerandomilast, which could be a benefit over currently approved products. There have been problems with headaches and gastrointestinal side effects with drugs of this type before, but the company is hoping that targeting the enzyme subtype PDE4B will help overcome this potential problem as it is preferentially found in the lungs.