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Inozyme Pharma

Inozyme Pharma logo
🇺🇸United States
Ownership
Public
Established
2016-01-01
Employees
59
Market Cap
$367.7M
Website
http://www.inozyme.com
Introduction

Inozyme Pharma, Inc. is a clinical-stage rare disease biopharmaceutical company. It engages in the business of developing novel therapeutics for the treatment of diseases impacting the vasculature, soft tissue, and skeleton. The company was founded by Axel Bolte, Joseph P. Schlessinger, and Demetrios T. Braddock in September 2015 and is headquartered in Boston, MA.

Clinical Trials

14

Active:3
Completed:4

Trial Phases

3 Phases

Phase 1:7
Phase 2:2
Phase 3:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (11 trials with phase data)• Click on a phase to view related trials

Phase 1
7 (63.6%)
Phase 2
2 (18.2%)
Phase 3
2 (18.2%)

The ENABLE Study: Safety and Efficacy Study of INZ-701 in Patients With ENPP1 Deficiency

Phase 2
Withdrawn
Conditions
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency
Autosomal Recessive Hypophosphatemic Rickets
Generalized Arterial Calcification of Infancy 1
Interventions
First Posted Date
2024-12-18
Last Posted Date
2025-05-01
Lead Sponsor
Inozyme Pharma
Target Recruit Count
40
Registration Number
NCT06739980

ADAPT Study: Long-term Safety Study of INZ-701 in Patients With ENPP1 Deficiency and ABCC6 Deficiency

Phase 2
Recruiting
Conditions
Gene Mutations
Pseudoxanthoma Elasticum
Arterial Calcification
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency
Autosomal Recessive Hypophosphatemic Rickets Type 2
Interventions
First Posted Date
2024-06-17
Last Posted Date
2024-11-28
Lead Sponsor
Inozyme Pharma
Target Recruit Count
200
Registration Number
NCT06462547
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

Clinilabs Drug Development Corporation, Eatontown, New Jersey, United States

🇫🇷

Necker-Enfants Malades Hospital, Paris, France

and more 2 locations

PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency

Recruiting
Conditions
Ectonucleotide Pyrophosphatase/Phosphodiesterase 1 Deficiency
ATP-Binding Cassette Subfamily C Member 6 Deficiency
First Posted Date
2024-03-08
Last Posted Date
2025-06-10
Lead Sponsor
Inozyme Pharma
Target Recruit Count
1000
Registration Number
NCT06302439
Locations
🇨🇦

CHU Sainte-Justine Research Centre, Montreal, Quebec, Canada

🇯🇵

The University of Tokyo Hospital, Tokyo, Japan

🇴🇲

Royal Hospital Muscat, Muscat, Oman

and more 10 locations

The SEAPORT 1 Study: Evaluation of the Safety and Tolerability of INZ-701 in Adults With End-Stage Kidney Disease Undergoing Hemodialysis

Phase 1
Completed
Conditions
Calciphylaxis
Interventions
First Posted Date
2024-02-28
Last Posted Date
2025-02-05
Lead Sponsor
Inozyme Pharma
Target Recruit Count
11
Registration Number
NCT06283589
Locations
🇺🇸

South Florida Nephrology Research, Coral Springs, Florida, United States

🇺🇸

Elixia Health, Hollywood, Florida, United States

The ENERGY 3 Study: Evaluation of Efficacy and Safety of INZ-701 in Children With ENPP1 Deficiency

Phase 3
Active, not recruiting
Conditions
Ectonucleotide Pyrophosphatase/Phosphodiesterase1 Deficiency
Generalized Arterial Calcification of Infancy
Autosomal Recessive Hypophosphatemic Rickets
Interventions
Drug: Control Arm (Conventional Therapy)
First Posted Date
2023-09-21
Last Posted Date
2025-05-01
Lead Sponsor
Inozyme Pharma
Target Recruit Count
27
Registration Number
NCT06046820
Locations
🇺🇸

Children's Hospital of Colorado, Aurora, Colorado, United States

🇦🇺

Queensland Children's Hospital, South Brisbane, Australia

🇸🇦

King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia

and more 12 locations
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News

BioMarin Acquires Inozyme Pharma for $270 Million, Adding Late-Stage Enzyme Therapy for Rare Genetic Disorder

BioMarin Pharmaceutical has entered into a definitive agreement to acquire Inozyme Pharma for $270 million, strengthening its enzyme therapy portfolio with the addition of INZ-701.

Inozyme's INZ-701 Shows Promise in ENPP1 Deficiency Trial with Sustained Phosphate Increases

Interim data from Inozyme Pharma's ENERGY 3 pivotal trial demonstrates INZ-701's potential to modify disease course in pediatric ENPP1 Deficiency patients, with sustained phosphate increases and favorable safety profile.

Big Pharma M&A Activity Surges as Companies Target Undervalued Biotechs Amid Market Recovery

Pharmaceutical M&A activity is experiencing a significant rebound with major deals including Novartis's $1.7 billion acquisition of Regulus Therapeutics and Merck KGaA's $3.9 billion purchase of SpringWorks Therapeutics.

Congress's Failure to Renew Priority Review Voucher Program Threatens Rare Disease Drug Development

The FDA's rare pediatric disease Priority Review Voucher program expired in December 2023, despite unanimous congressional support for renewal, leaving biotech companies unable to receive new vouchers worth approximately $150 million.

Inozyme's INZ-701 Shows Promise in ENPP1 and ABCC6 Deficiencies

• Inozyme Pharma's INZ-701 demonstrated improved survival rates in infants with ENPP1 Deficiency, with 80% surviving beyond one year compared to a historical 50%. • The ENERGY 3 pivotal trial of INZ-701 in pediatric patients with ENPP1 Deficiency has completed enrollment, with topline data expected in early 2026. • Preliminary regulatory support has been received for the ASPIRE pivotal trial of INZ-701 in children with ABCC6 Deficiency, targeting major adverse clinical events. • INZ-701 was well-tolerated in trials, showing substantial reductions or stabilization of arterial calcifications and improvements in heart function in treated patients.

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