Alcea Therapeutics is a preclinical therapeutics company focused on treating airway inflammation through immune tolerance.

Boston, MA & New York, NY
About Alcea
Unmet Clinical Needs
During any acute airway inflammation attack, an active inflammation response and an appropriately efficient resolution are equally important. Indeed, the inability to strike the fine balance between being protected and overreacting is often the engine to more serious pathologies. The failure to resolve inflammatory immune responses results in chronic inflammatory airway diseases.

Chronic airway inflammation is a general feature of asthma that affects more than 350 million people worldwide and causes around 400,000 deaths. In the US, asthma is the most common reason for hospital admissions following an emergency department visits. Although inflammation is common to all forms of asthma, mechanisms activating the immune system differ and ways to treat inflammation have to be adapted. While a number of treatments targeting severe eosinophilic asthma have come out over the past decade, there is still no treatment beyond steroids for non-eosinophilic asthma. For this population, hospital visits are frequent and side effects from maladapted treatment options are burdensome. Chronic airway inflammation is also a critical issue in COPD, cystic fibrosis (CF), and bronchopulmonary dysplasia (BPD).

Current strategies to treat these chronic pathologies focus in large part on inhibiting pro-inflammatory pathways systemically. The challenge to such strategies is to effectively shut down part of the immune response without leaving the patients vulnerable to opportunistic pathogens or crippled by side effects. Due to different profiles of inflammatory responses, however, no single strategy has proven itself to be effective for all people, and response rates for existing therapies have generally been poor.

Increasing specificity without sacrificing efficacy is a difficult path to walk.
Alcea’s Solution
Alcea Tx focuses on a new path to treat airway inflammation. While most approved medications seek to treat symptoms, the company’s lead monoclonal antibody assets focus on rebalancing the immune system to treat inflammation at its root cause.

In a healthy state, regulatory T-cells (Tregs) have an anti-inflammatory function that ensures an efficient resolution to inflammation. In conditions including asthma, viral infection, and COPD, however, Alcea’s scientific founders recognized that Tregs are dysregulated, leading to the production of pro-inflammatory Tregs which escalate an immune response causing exacerbation of the inflammatory environment and worsening of disease.

Using its lead monoclonal antibodies, Alcea Tx has successfully shown in preclinical models that inhibiting these pro-inflammatory Tregs prevents the development of acute attacks, reduces all markers of inflammation, and slows down fibrosis and collagen disposition.

Alcea Tx’s technology is based on research from the leading lab studying Tregs at Boston Children’s Hospital/Harvard Medical School.
Alcea’s lead candidates show great efficacy in preclinical models
Alcea’s lead candidates show great efficacy in preclinical models
Targeted Diseases
The following diseases are targeted by Alcea’s immune-tolerance restoration technology.

Asthma is one of the sharp-raising diseases in urban countries. It affects more than 25 million Americans. This represents 7.7% of adults and 8.4% of children. Asthma causes the medical system in the US more than $56B of yearly costs. The direct costs make up almost $50.1B, of which hospital stays are the largest share. Indirect costs make up $5.9B. The main treatment for asthma has been either dampening of the immune system using corticosteroids, treating some of the main symptoms such as bronchoconstriction by using Beta-agonists, or trying to treat the effector mechanisms by using biologics. These treatments had both low response rates and serious side effects.

Alcea’s technology targets an entirely different pathway. It aims to restore immune tolerance in the lungs and thus to reset homeostasis. Alcea’s lead asset targets Treg cells in order to recover their immuno-suppressive function, maintaining the rest of the immune system functional.

Pulmonary Viral infections
Respiratory diseases and mainly viral infections of the lungs are the third leading cause of hospitalization in the US. One the main reasons is the yearly Influenza virus infections. It affects more than 31.4 million outpatient visits involving 10.6 million patients and 3.1 million days in hospital. The annual medical costs are in excess of $10B, and the disease accounts for more than 40,000 deaths a year. The current medications for Influenza virus infection can protect from mild and moderate cases of the disease while severe cases are poorly treated. Recently, SARS-CoV2 virus has emerged, causing COVID-19 infection affecting different organs, mainly the lungs. While the use of Dexamethasone, a corticosteroid, has helped severe cases, other leads such as Remdesivir or Baricitinib have yet to show consistent positive results. Alcea Tx’s technology has been validated in preclinical mouse models as well as humanized mouse models for H1N1 influenza virus and proved to restore immune tolerance in the lung. Moreover, by restoring the healing activity of the Treg cells, we were able to enhance tissue healing and tissue restoration and thus decrease the incident of the secondary infections considered as the main cause of death for patients on ventilators.We are currently validating our technology in other models for SARS-CoV2 viral infection in anticipation to get our leading asset further into clinics.
The Founding Team
Dr. Talal Chatila

Dr. Chatila is an Attending Physician in the Division of Immunology at Boston Children’s Hospital and the Denise and David Bunning Professor of Pediatrics at Harvard Medical School. He also serves as an expert for the Department of Allergy and Immunology for Boston Children's Hospital Precision Medicine Service. He has published extensively on inflammation and allergies and has contributed greatly in describing and characterizing regulatory T cells.
Dr. Hani Harb

Dr. Harb is an assistant professor of infectious immunology at the Technical University of Dresden. He holds a Bachelors in Pharmaceutical Sciences Masters and PhD in Immunology from Philipps University Marburg, Germany.

His research focuses on inflammatory diseases of the lung including Asthma, COPD, Viral lung infections and Bacterial ARDS in the context of epigenetic modifications.

He serves as an associate editor in different frontiers journals. He is the president of the German-Syrian Research Society.
Wanda Phipatanakul, MD, MS
Clinical & Scientific Advisor

Dr Phipatanakul is the S. Jean Emans, MD Endowed Professor of Pediatrics at Harvard Medical School and directs the Boston Children's Hospital Clinical Research Center, Asthma / Allergy / Immunology & Dermatology / Rheumatology. She has experience in recruiting large clinical cohorts and bridging work from the bench to the clinic. Her research has broad applications related to the environment and epidemiologic risk factors, immune based therapeutics and conducts large clinical intervention trials in respiratory disease, airway inflammation, asthma, allergic and immunologic diseases.

She also has extensive experience developing key relationships with biotech and pharmaceutical companies and regulatory agencies including the FDA, holding and managing IND's, and serving on Data Safety Monitoring Boards. Her cohorts and collaborative work with Drs Chatila and Harb establishes key scientific principals on the pathways critical in T regulatory immune biology and airway inflammation.
Geoffrey W. Smith

Geoff is the Founder and Managing Partner of Digitalis. He is also a Co-Founder and General Partner of Ascent Biomedical Ventures, a New York City-based venture capital firm focused on early-stage life sciences investments. Geoff currently represents Ascent on the Board of Directors of Azevan Pharmaceuticals, BlinkBio, and Orchestra Biomedical.

Geoff serves as a Trustee of The Jackson Laboratory. He is also a member of the Scientific Advisory Board for Brigham & Women’s Hospital in Boston. Previously, he was the founding Director of the Mount Sinai Institute of Technology and a Professor in the Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai. Geoff received a B.A. from Williams College and a J.D. from the University of Pennsylvania Law School.
Jonathan Friedlander, PhD

Jonathan is a Principal at Digitalis, focusing on early stage life-science investment. Prior to leading operations at Alcea Tx, Jonathan got a PhD in cell biology from the University of Cambridge and an MBA from the Harvard Business School, and worked at Flagship Pioneering focusing on company creation.