Hope for LPR

N-Zyme Biomedical seeks to provide much-needed, safe, effective and efficient treatments for the millions of people in the US and worldwide that suffer from LPR.
» What is LPR?About N-Zyme →
Research

Our goal and how we seek to treat LPR

Despite the high prevalence of LPR, socioeconomic cost and burden on quality of life, there is currently no effective medical therapy. Pepsin, detected in the airway of patients with LPR and now known to cause inflammation and promote disease independent of gastric acid, is a key therapeutic target.

Our groundbreaking research demonstrates fosamprenavir binds to and inhibits pepsin, preventing pepsin-mediated inflammation and tissue damage. N-Zyme is developing a sustained-release oral formulation of fosamprenavir for the treatment of reflux. Furthermore, an innovative delivery approach will provide local delivery of a low dose of fosamprenavir direct to the throat.

Our hope is that these systemic and aerosolized medications that are under development will represent the first safe, effective, and efficient treatments for the millions of people that suffer from LPR, addressing a significant unmet clinical need.
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Innovation for the reflux industry

Drug development pipeline

N-Zyme is working on bringing a new class of medication to the reflux industry by creating the world’s first pepsin inhibitor for LPR & GERD.

Systemic Program

NZYM-001
Oral suspension - LPR
Preclinical
In Vitro
In Vivo
Phase 2 PoC
Phase 3
Therapeutic Area
Reflux
Program
NZYM-001
Oral suspension pepsin inhibitor
Details
Repurposing approach, using approved drug dosing and route of administration, fast-tracks program to Phase II Proof of Concept clinical trials to assess efficacy for LPR.
Status
Phase 2
Proof of Concept
Indication
Laryngopharyngeal Reflux (LPR)
NZYM-003
Oral suspension - GERD
Preclinical
Phase 2 PoC
Phase 3
Market
Therapeutic Area
Reflux
Program
NZYM-003
Oral suspension pepsin inhibitor
Details
Repurposing approach, using approved drug dosing and route of administration, fast-tracks program to Phase 2 Proof of Concept clinical trials to assess efficacy for GERD.
Status
Preclinical
Indication
Gastroesophageal Reflux Disease (GERD)

Aerosolized Program

NZYM-002
Dry powder inhaler
Preclinical
Phase 1
Phase 2
Phase 3
MArket
Therapeutic Area
Reflux
Program
NZYM-002
Inhaled pepsin inhibitor
Details
Pre-GLP studies confirmed safety and efficacy. GLP inhalation toxicology studies underway.
Status
Preclinical
Indication
Laryngopharyngeal Reflux (LPR)
NZ-004
Chemical denomination
Phase 1
Phase 2
Phase 3
Phase 4
Phase 5
Therapeutic Area
Reflux
Program
NZYM-001 (Oral suspension pepsin inhibitor)
Details
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Status
Phase III
Indication
Laryngopharyngeal Reflux (LPR)

Systemic Program

NZYM-001
Oral suspension - LPR
Therapeutic Area
Reflux
Program
NZYM-001
Oral suspension pepsin inhibitor
Details
Repurposing approach, using approved drug dosing and route of administration, fast-tracks program to Phase 2 Proof of Concept clinical trials to assess efficacy for LPR.
Status
Phase 2 PoC
Indication
Laryngopharyngeal Reflux (LPR)
✓
Preclinical
✓
In vitro
✓
In vivo
.
Phase 2 PoC
.
Phase 3
NZYM-003
Oral suspension - GERD
Therapeutic Area
Reflux
Program
NZYM-003
Oral suspension pepsin inhibitor
Details
Repurposing approach, using approved drug dosing and route of administration, fast-tracks clinical trials to assess efficacy for GERD.
Status
Preclinical
Indication
Gastroesophageal Reflux Disease (GERD)
✓
Preclinical
✓
Phase 2 PoC
✓
Phase 3
.
Market

Aerosolized Program

NZYM-002
Dry powder inhaler
Therapeutic Area
Reflux
Program
NZYM-002
Inhaled pepsin inhibitor
Details
Pre-GLP studies confirmed safety and efficacy. GLP inhalation toxicology studies underway.
Status
Preclinical
Indication
Laryngopharyngeal Reflux (LPR)
✓
Preclinical
✓
Phase 1
✓
Phase 2
.
Phase 3
.
Market
Patents

U.S. Patent Application No. 63/392,929
Filed July 28, 2022
‍
Sustained-release oral Fosamprenavir for the treatment of reflux
Inventors: Nikki Johnston and Franco Gennaro Vigile
Applicants: The Medical College of Wisconsin, Inc. and N-Zyme Biomedical Inc.

International Patent Application: PCT/US2021/027758
FILED April 16, 2021
‍
Aerosolized formulations of HIV protease inhibitors for the treatment of airway reflux
Inventors: Nikki Johnston
Applicants: The Medical College of Wisconsin, Inc.

Developing an oral sustained-release formulation of fosamprenavir

We are developing a new, sustained-release oral fosamprenavir formulation containing sodium alginate, which we hypothesize will increase muco-adhesion and prolong esophageal retention and contact time. Local esophageal delivery of a pepsin inhibitor such as fosamprenavir is expected to benefit to the ~50% of LPR patients that have GERD.
N-Zyme Biomedical’s Co-Founder and Chief Scientific Officer, Dr. Nikki Johnston, has been selected as a 2021 Falk Medical Research Trust Catalyst Award recipient.
This award comes with a grant that will go towards the reformulation process for our aerosolized drug development program.
N-Zyme Biomedical’s Co-Founder and Chief Scientific Officer, Dr. Nikki Johnston, has also been selected as a 2022 Falk Medical Research Trust Transformational Award recipient.
This award comes with a grant that will go towards the reformulation process for our aerosolized drug development program.

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