Aerovate Therapeutics Emerges From RA Capital Incubator With $72.6 Million Funding for Potential Disease-Modifying Pulmonary Arterial Hypertension Therapy - GlobeNewswire
Aerovate Therapeutics Emerges From RA Capital Incubator With $72.6 Million Funding for Potential Disease-Modifying Pulmonary Arterial Hypertension Therapy - GlobeNewswire |
| Posted: 06 Aug 2020 06:40 AM PDT  The Series A for Aerovate, which was founded and incubated by RA Capital Management, is led by Sofinnova Investments, a new investor in the company. Atlas Venture, Cormorant Asset Management, Surveyor Capital (a Citadel company) and Osage University Partners are the other new investors in the round."Aerovate is a biotechnology company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. It is exciting to secure financing from such a strong syndicate to progress AV-101, our lead program," said Aerovate founding President Benjamin Dake, PhD. He noted that the financing will take AV-101 through a clinical efficacy read-out, with a registrational trial scheduled to begin during the first half of 2021 with PAH patients. "Sufferers of PAH desperately need a disease-modifying therapy," Dake added.AV-101 is an easy-to-use, proprietary dry powder formulation of imatinib that delivers the medicine directly to the lungs. This approach should decrease the systemic adverse effects that hampered the oral version in PAH trials -- by reducing systemic exposure to the drug while simultaneously increasing the dose of medicine delivered directly to diseased lung tissues. AV-101 is administered with a simple inhaler, providing a convenient solution for patients compared to more cumbersome nebulized drugs currently approved in PAH. Those often require prolonged dosing protocols lasting many minutes, multiple times a day, including complicated device assembly and filling – likely reducing patient adherence and impacting real-world efficacy.Aerovate emerged out of RA Capital's seed and incubation program. The concept and proprietary drug product underlying AV-101 were co-invented by the RA Capital venture group and supported by its incubator, Carnot Pharma."With the support of the high caliber syndicate around the table, I believe Aerovate is poised to move this important treatment into the clinic immediately. This financing keeps the company on a rapid path towards offering this potentially transformational therapeutic to patients with real need," said RA Capital Managing Director and Aerovate Board Chair Joshua Resnick, MD. "AV-101 strives to provide PAH patients with the benefits of a disease modifying drug – in an easy-to-use format, free from the inconvenience of nebulized products – without the cancer-drug-like side effects of the oral version. This is extremely encouraging news for sufferers of this disease," said Resnick."We are excited about AV-101's potential because the core molecule, imatinib, has shown real efficacy for this use, including cases of hemodynamic remission in severely ill PAH patients. Aerovate's team and their deep experience with PAH and aerosol development suggest that AV-101 may progress quickly and successfully through trials," said Sofinnova General Partner and Aerovate Board Director Maha Katabi, PhD."Pulmonary arterial hypertension is a chronic disorder with a poor quality of life and five-year survival rate of only 57%. In multiple trials, imatinib showed strong clinical benefit for PAH patients that lasted for many months; they experienced improved exercise capacity, lower pulmonary vascular resistance, decreased pulmonary artery pressure and increased cardiac output. Imatinib addresses the underlying cause of the disease, unlike currently available vasodilator therapies," said Aerovate Chief Medical Officer Hunter Gillies, MD. "Building on imatinib's established efficacy, our research gives us strong confidence that AV-101, through targeted delivery to the lungs, will minimize systemic adverse effects, provide good tolerability and potentially be even better at treating the underlying disease than the oral version.""Given the significant unmet need in PAH, I am excited about leveraging my experience in developing novel products for underserved pulmonary diseases. Having successfully led the Esbriet team through approval for the treatment of IPF in the US, I look forward to working with Aerovate's talented team to develop AV-101 to augment the current standard of care in PAH," said Aerovate independent Board Director Jonathan Leff, MD.The Aerovate board will include Atlas Venture Partner David Grayzel, MD, along with Dake, Katabi, Leff and Resnick.About PAHPAH is a disorder that progresses rapidly and afflicts approximately 80,000 people worldwide and for which there are, to date, no approved disease-modifying therapies. PAH is a proliferative disorder of the pulmonary vasculature characterized by remodeling, constriction and occlusion of the small pulmonary arteries resulting in elevated blood pressure in the pulmonary circulation. PAH causes significant strain on the heart, leading to limited physical activity, heart failure and reduced life expectancy. Even with the current standard of care vasodilator therapies, which dilate pulmonary vessels but do not directly modify the disease, PAH often progresses at a fast pace. Aerovate estimates that, based on $5 billion annual sales from the currently approved vasodilator drugs, the market for disease-modifying PAH therapies is significant.About Aerovate TherapeuticsAerovate Therapeutics is a biotechnology company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease. Aerovate's lead program is a potentially disease modifying drug, AV-101, for people who suffer from pulmonary arterial hypertension (PAH). AV-101 is a proprietary inhaled dry powder formulation of the drug imatinib that delivers this medicine directly to diseased lung tissues while reducing systemic adverse side effects. Aerovate was founded and incubated by RA Capital Management, a multi-stage investment manager focused on healthcare and life sciences. For more information, please visit www.aerovatetx.comAbout RA Capital ManagementRA Capital Management is a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies developing drugs, medical devices, and diagnostics. For more information, please visit www.racap.comAbout Sofinnova InvestmentsSofinnova Investments is a biopharmaceutical investment firm with approximately $2.2B in assets under management. Sofinnova invests in both private and public therapeutics-focused biotech companies, in both the U.S. and Europe, across all stages of company formation and growth seeking to build world class companies that aspire to dramatically improve the current state of medical care today and ultimately, the lives of patients. For more information, please visit www.sofinnova.comMedia Contact: Michael-Jon Romano Sommerfield Communications Michael-jon@sommerfield.com +1 (212) 255-8386  |
| Casting a wider net to catch more cases of pulmonary hypertension - Medical Xpress Posted: 28 Jul 2020 10:11 AM PDT  When most people think of high blood pressure, they think of being tested with an arm cuff at a doctor's appointment. That type of blood pressure is separate from pulmonary hypertension (PH), which is high blood pressure in the lung arteries. In a study published today in The Lancet Respiratory Medicine, investigators from Brigham and Women's Hospital took an evidence-based approach to determine the lower end of the risk spectrum for PH based on pulmonary vascular resistance (PVR), which is resistance against blood flow from the pulmonary artery to the lungs. The team presents evidence that by redefining the lower risk level for PVR, 60 percent more patients who are at risk for death due to PH can be diagnosed. "The findings of this study cast the clinical profile of patients who have PH and are at risk for major clinical events into a new and wider light," said corresponding author Bradley Maron, MD, an associate physician in the Division of Cardiovascular Medicine at the Brigham. "We can use this information to raise awareness among clinicians on those patients that may need reconsideration for risk factor modification, conventional treatment, and potential clinical trial enrollment." PH affects 70 million people worldwide across a broad age, geographic and socioeconomic spectrum. Left untreated, average survival is 2 to 3 years after diagnosis. PH can cause serious problems because changes in blood pressure in the lung arteries are not tolerated well by the heart and can lead to hospitalization, heart failure and death. Despite being a grave condition, the way PH was defined in clinical practice previously was not evidence-based and did not account for physiological changes in blood pressure, such as may occur due to circumstances that are immediately reversible. Although PVR was already considered important in the prognosis of PH, the actual range of PVR that is informative of PH was not known. The researchers analyzed the association of PVR and mortality using the Veterans Association (VA) national database, which includes comprehensive information on patients' medical histories and clinical events. The researchers acknowledge the limitations to working with a national population relative to errors in measurements. Also, the VA population is almost entirely male, so the team validated the findings in a sex-balanced cohort at Vanderbilt University Medical Center to account for both men and women. The data analysis did account for comorbidities but was not positioned to distinguish between the different stages of diseases that could affect outcome, such as the degree of lung disease in individual patients. The results indicated that starting at a PVR of around 2.2 Wood Units (a standard unit of measurement for PVR), there is an increase in association with mortality among patients with increased pulmonary artery pressure. This 2.2 level is well below what is currently associated with the disease in clinical practice. The new, lower threshold expands the range of patients who are considered to have PH and optimizes the specificity of PH criteria used clinically. "Pulmonary hypertension is often overlooked in clinical practice, but this study provides a specific context for clinicians and health care workers to understand the range of risk for a large group of patients," said Maron. "We have established an evidence-based way to recognize patients with PH who would have otherwise been considered to be normal, but, in fact, have a concerning profile." From here, the team is interested in looking at populations that were not included in this study, including patients with less common forms of PH or PH that exists in the absence of heart and lung disease. More information: Bradley A Maron et al, Pulmonary vascular resistance and clinical outcomes in patients with pulmonary hypertension: a retrospective cohort study, The Lancet Respiratory Medicine (2020). DOI: 10.1016/S2213-2600(20)30317-9 Provided by Brigham and Women's Hospital Citation: Casting a wider net to catch more cases of pulmonary hypertension (2020, July 28) retrieved 7 August 2020 from https://medicalxpress.com/news/2020-07-wider-net-cases-pulmonary-hypertension.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.  |
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