Vasa Therapeutics Announces Initiation of Phase 1 First-in-Human Clinical Trial of VS-041 for the Treatment of Heart Failure with Preserved Ejection Fraction

• Vasa Therapeutics granted MHRA Clinical Trial Authorization (CTA) for VS-041 for the treatment of heart failure with preserved ejection fraction (HFpEF)
• Company's seed funding extended to $11M

ENCINITAS, Calif. and WROCLAW, Poland, Sept. 3, 2024 /PRNewswire/ -- Vasa Therapeutics  ("Vasa"), a clinical stage biopharmaceutical company developing novel therapies for cardiovascular and metabolic aging, announced today that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has granted clinical trial authorization (CTA) for Vasa to commence a Phase 1 first-in-human clinical trial to evaluate the safety, tolerability, and pharmacokinetics of its investigational drug VS-041 in healthy adult participants. VS-041 is an oral compound with a novel mechanism of action for the potential treatment of heart failure with preserved ejection fraction (HFpEF).

"The MHRA's authorization marks a major step forward in our mission to develop VS-041 as a disease-modifying therapy for HFpEF," said Artur Plonowski, MD, PhD, Chief Executive Officer, Vasa Therapeutics. "There are currently no approved HFpEF treatments that improve structural properties of myocardium and provide durable clinical benefit. By inhibiting the release of endotrophin, a biomarker and mediator of fibrotic and inflammatory responses, VS-041 has the potential to become the first personalized approach in HFpEF management that could be used in patients with elevated levels of endotrophin who have a high risk of an unfavorable prognosis."

The commencement of the Phase 1 trial of VS-041 coincides with an extension of the Company's seed funding, bringing the total round to $11 million.  The financing was led by Orphinic Scientific SA with participation from i&i Biotech Fund I SCSp. Proceeds will support the clinical development of VS-041 and advancement of Vasa's preclinical programs.

About HFpEF and endotrophin

Heart failure is a serious condition that affects more than 64 million people worldwide.¹   Approximately 6.7 million Americans have heart failure, which is expected to increase to over 8.5 million Americans by 2030.² Nearly half of patients with heart failure have heart failure with preserved ejection fraction (HFpEF)³, and the prevalence of HFpEF is increasing.^2,4 Approximately 75% of patients with HFpEF will die within five years of initial hospitalization, and 84% will be rehospitalized.² Currently approved therapies for HFpEF provide clinical improvement but do not result in disease modification and durable improvement upon discontinuation of the treatment.⁵

Endotrophin, a collagen type VI–derived signaling peptide, has been linked to cardiac metabolic dysregulation, inflammation, and fibrosis. Baseline plasma endotrophin levels HFpEF patients were shown to be strongly and independently associated with increased risk of poor outcomes (deaths or heart failure rehospitalizations).⁶

About VS-041

VS-041 is an oral compound that was discovered and developed by Vasa for the potential treatment of HFpEF. VS-041 robustly reduces cardiac fibrosis and significantly improves diastolic heart functions in a preclinical HFpEF model. The compound also inhibits the release of endotrophin from primary human cardiac fibroblasts. In GLP toxicology studies, VS-041 demonstrated a highly favorable safety and tolerability profile. Preclinical development of VS-041 was co-funded by the European Regional Development Fund and the Polish National Centre for Research and Development (POIR.01.01.01-00-1210/19-01).

About Vasa Therapeutics

Vasa is a privately held biopharmaceutical company developing therapeutics that target pathophysiologies of cardiovascular and metabolic aging. In addition to VS-041, Vasa developed a cutting-edge platform for long-acting apelin for combination treatment with incretins in obesity, especially for patients at risk for skeletal muscle loss or cardiovascular disease. As a monotherapy, long-acting apelin agonists could also be beneficial in treating muscle atrophy, heart failure, chronic kidney disease, or peripheral artery disease. Vasa's preclinical pipeline also includes a best-in-class inhibitor of CamKIId for heart failure and life-threatening arrhythmias.

For more information, please visit www.vasatherapeutics.com

References:

1. James et al. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2018; 392: 1789–858.
2. Bozkurt B, Ahmad T, Alexander KM, Baker WL, Bosak K, Breathett K, Fonarow GC, Heidenreich P, Ho JE, Hsich E, Ibrahim NE, Jones LM, Khan SS, Khazanie P, Koelling T, Krumholz HM, Khush KK, Lee C, Morris AA, Page RL 2nd, Pandey A, Piano MR, Stehlik J, Stevenson LW, Teerlink JR, Vaduganathan M, Ziaeian B; Writing Committee Members. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of America. J Card Fail. 2023 Oct;29(10):1412-1451. doi: 10.1016/j.cardfail.2023.07.006. Epub 2023 Sep 26. PMID: 37797885; PMCID: PMC10864030.
3. Dunlay SM, Roger VL, Weston SA, Jiang R, Redfield MM. Longitudinal changes in ejection fraction in heart failure patients with preserved and reduced ejection fraction. Circ Heart Fail. 2012 Nov;5(6):720-6. doi: 10.1161/CIRCHEARTFAILURE.111.966366. Epub 2012 Aug 30. PMID: 22936826; PMCID: PMC3661289.
4. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA Guideline for the Management of Heart failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013;128:e240-e327.
5. Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022.
6. Chirinos JA, Zhao L, Reese-Petersen AL, Cohen JB, Genovese F, Richards AM, Doughty RN, Díez J, González A, Querejeta R, Zamani P, Nuñez J, Wang Z, Ebert C, Kammerhoff K, Maranville J, Basso M, Qian C, Rasmussen DGK, Schafer PH, SeifFert D, Karsdal MA, Gordon DA, Ramirez-Valle F, Cappola TP. Endotrophin, a Collagen VI Formation-Derived Peptide, in Heart Failure. NEJM Evid. 2022 Oct;1(10):10.1056

SOURCE Vasa Therapeutics