AZTherapies – Home

TACKLING NEUROINFLAMMATION

Our lead program is built on a multi-modal approach that recognizes neuroinflammation as a root cause of serious neurodegeneration and seeks to stop or slow the progression of disease. Our Phase 3 COGNITE trial in early Alzheimer’s Disease is almost fully enrolled, with expected study completion in the fourth quarter of 2020.

AZTherapies’ approach shifts the brain’s own immune cells, the microglia, from an aggressive, pro-inflammatory state to a neuroprotective, phagocytic state, while also inhibiting amyloid-beta plaque formation and neuroinflammation by dampening pro-inflammatory cytokine and mast cell activation.

AZTherapies At A Glance

01

BREAKTHROUGH SCIENCE

Neuroinflammatory mechanism that changes the activation state of microglial brain immune cells from an aggressive, pro-inflammatory state to an anti-inflammatory, neuroprotective state.
02

EXECUTION

Advanced Phase 3 trial of a novel drug combination. Completed two Phase 1 studies in healthy and AD patients. Approved IND for P2 study in post-ischemic stroke. Next-generation compound pre-IND.
03

PATENT PORTFOLIO

More than 100 patents & pending applications claiming novel compositions of matter, formulation, manufacturing and device/delivery for numerous neurodegenerative and other indications.
04

PIPELINE

Multiple follow-on programs with potential to treat and slow the progression of neurodegenerative diseases, while improving the quality of life of the aging population.
05

LEADERSHIP

World class management team, Board of Directors, Scientific Advisory Board, and Business Advisory board.

“Beyond the amyloid approach, an alternate line of thought based on the role of mast cells and microglia is neuro-inflammation and the potential targeting of these cells for the treatment of [Alzheimer’s disease] represents a paradigm shift in therapeutic strategies.”

GlobalData, Neuroimmunology Drug Development Report, Dec 2018

LATE STAGE, GROWING PIPELINE

We are progressing a growing pipeline of candidates to treat patients with few therapeutic options. Following our lead program in Alzheimer’s disease, we are advancing candidates for the treatment of amyotrophic lateral sclerosis (ALS) and post-ischemic stroke cognitive impairment.

  • DISCOVERY
  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3
DISCOVERY
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3
ALZT-OP1 | Early Alzheimer’s Disease
ALZT-OP1a (AZT-101) | Ischemic Stroke – Phase 2 ready
ALZT-OP1a (AZT-101) | ALS – Phase 1/2 planning underway
AZT-211 (Next-Gen) | Alzheimer’s Disease – IND 1H 2020
AZT-301 | Parkinson’s Disease
AZT-366 | M1 Muscarinic Receptor Agonist
AZHALER Device | Broad Potential Use

ALZT-OP1: First-in-class candidate to slow the progression of Alzheimer’s disease

  • Unique multi-modal approach that includes attacking the neuroinflammation that leads to neuronal death by shifting the brain’s microglial immune cells to their neuroprotective state
  • A combination treatment consisting of an optimized formulation to improve delivery of cromolyn for inhalation plus oral ibuprofen
  • Designed as a convenient and easy-to-use pulmonary and oral delivery kit for once-daily home use
  • Clear regulatory pathway using validated rating scales of dementia
  • • Conducted under a Special Protocol Assessment (SPA) with the FDA
  • • 600-patient, Phase 3, global placebo-controlled clinical trial (COGNITE) in patients with early Alzheimer’s disease is more than 95% enrolled
  • • Qualifies for a 505(b)2 streamlined FDA approval process

RESULTS-DRIVEN LEADERSHIP

With a demonstrated track record of successful commercial drug development

Rollover photos to view team bios

David R. Elmaleh, Ph.D.

FOUNDER, CEO & CHAIRMAN OF THE BOARD

David also currently serves as Associate Professor, Harvard Medical School, and Director of Contrast Media Chemistry at Massachusetts General Hospital. David’s research focus includes therapeutic and imaging compounds to improve the effectiveness of therapies for CNS, ischemic and cardiovascular disorders. He is also co-founder of Mersana Therapeutics, PureTech, and Molecular Insights. David’s work has led to six approved treatments representing more than a billion dollars in shareholder value.

Karen R. Reeves, M.D.

CHIEF MEDICAL OFFICER & PRESIDENT

Karen brings more than 20 years of industry experience in Phase 1 through Phase 4 drug development, across multiple therapeutic areas, including neuroscience, oncology, immunology, and women’s health. Karen served in multiple leadership roles at Pfizer in R&D, Regulatory, Clinical Quality, and BD, including Vice President, Neuroscience Clinical Development, and provided leadership for multiple drug approvals, including leading drugs in neuroscience, Geodon/IM, and Chantix, which won the Prix Galien for Best Pharmaceutical. Karen has also served as Vice President, Global Head of Medical Science at Astellas Pharma.

Jay Mohr

CHIEF OPERATING & BUSINESS OFFICER, HEAD OF COMMERCIAL DEVELOPMENT

Jay has more than 25 years of biopharmaceutical industry experience delivering significant shareholder value, having served as co-founder and Managing Director of Locust Walk and co-founder and CEO of a development stage cancer company, Gloucester Pharmaceuticals (acquired by Celgene for $640M for 6x return). He also has significant commercial experience, including the launches of two blockbuster products: Rebif (Serono) for MS and Nasonex (Schering-Plough).

Robert S. Warren

SENIOR FINANCIAL ADVISOR

Robert has been lead counsel on dozens of biotech and M&A transactions, representing both strategic and private equity buyers and biotech company sellers, including the sale of iQuum to Roche in 2014 and the sale of deCode Genetics to Amgen in 2013. Robert most recently served as Corporate Partner in the Life Sciences Practice Group at Foley Hoag, LLP.

Rudolph E. Tanzi, Ph.D.

CHAIR, SCIENTIFIC ADVISORY BOARD

Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Mass General Hospital. His main focus is identifying and characterizing AD-associated gene mutations and variants with the ultimate goal of defining molecular, cellular, and biochemical events leading to neuronal death in brains of AD patients. Dr. Tanzi co-discovered the three early onset familial Alzheimer’s disease genes and the first innate immune microglial gene associated with AD, CD33. He also invented the Alzheimer’s-in-a-dish brain organoid model.

Michael E. Porter, Ph.D.

CHAIR, BUSINESS ADVISORY BOARD

Dr. Porter is an economist, researcher, author, advisor, speaker and teacher. He is Bishop William Lawrence University Professor at Harvard Business School. Throughout his career at HBS, he has brought economic theory and strategy concepts to bear on many of the most challenging problems facing corporations, economies and societies, including market competition and company strategy, economic development, the environment, and health care. His extensive research is widely recognized in governments, corporations, NGOs, and academic circles around the globe.

David R. Elmaleh, Ph.D.

FOUNDER, CEO & CHAIRMAN OF THE BOARD

David also currently serves as Associate Professor, Harvard Medical School, and Director of Contrast Media Chemistry at Massachusetts General Hospital. David’s research focus includes therapeutic and imaging compounds to improve the effectiveness of therapies for CNS, ischemic and cardiovascular disorders. He is also co-founder of Mersana Therapeutics, PureTech, and Molecular Insights. David’s work has led to six approved treatments representing more than a billion dollars in shareholder value.

Karen R. Reeves, M.D.

CHIEF MEDICAL OFFICER & PRESIDENT

Karen brings more than 20 years of industry experience in Phase 1 through Phase 4 drug development, across multiple therapeutic areas, including neuroscience, oncology, immunology, and women’s health. Karen served in multiple leadership roles at Pfizer in R&D, Regulatory, Clinical Quality, and BD, including Vice President, Neuroscience Clinical Development, and provided leadership for multiple drug approvals, including leading drugs in neuroscience, Geodon/IM, and Chantix, which won the Prix Galien for Best Pharmaceutical. Karen has also served as Vice President, Global Head of Medical Science at Astellas Pharma.

Jay Mohr

CHIEF OPERATING & BUSINESS OFFICER, HEAD OF COMMERCIAL DEVELOPMENT

Jay has more than 25 years of biopharmaceutical industry experience delivering significant shareholder value, having served as co-founder and Managing Director of Locust Walk and co-founder and CEO of a development stage cancer company, Gloucester Pharmaceuticals (acquired by Celgene for $640M for 6x return). He also has significant commercial experience, including the launches of two blockbuster products: Rebif (Serono) for MS and Nasonex (Schering-Plough).

Robert S. Warren

SENIOR FINANCIAL ADVISOR

Robert has been lead counsel on dozens of biotech and M&A transactions, representing both strategic and private equity buyers and biotech company sellers, including the sale of iQuum to Roche in 2014 and the sale of deCode Genetics to Amgen in 2013. Robert most recently served as Corporate Partner in the Life Sciences Practice Group at Foley Hoag, LLP.

Rudolph E. Tanzi, Ph.D.

CHAIR, SCIENTIFIC ADVISORY BOARD

Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Mass General Hospital. His main focus is identifying and characterizing AD-associated gene mutations and variants with the ultimate goal of defining molecular, cellular, and biochemical events leading to neuronal death in brains of AD patients. Dr. Tanzi co-discovered the three early onset familial Alzheimer’s disease genes and the first innate immune microglial gene associated with AD, CD33. He also invented the Alzheimer’s-in-a-dish brain organoid model.

Michael E. Porter, Ph.D.

CHAIR, BUSINESS ADVISORY BOARD

Dr. Porter is an economist, researcher, author, advisor, speaker and teacher. He is Bishop William Lawrence University Professor at Harvard Business School. Throughout his career at HBS, he has brought economic theory and strategy concepts to bear on many of the most challenging problems facing corporations, economies and societies, including market competition and company strategy, economic development, the environment, and health care. His extensive research is widely recognized in governments, corporations, NGOs, and academic circles around the globe.