Praetego’s first Amadorin, PimoxIV, is an intravenous (IV) infusion drug candidate to mitigate COVID-19 kidney risk.
Praetego’s novel small molecules (the Amadorins) offer the possibility of systemic protection from glucose damage. Treatment with an Amadorin could radically improve the health of diabetic and pre-diabetic patients.
Glucose fuels a non-enzymatic process that damages proteins and leads to harmful byproducts called Advanced Glycation end-products, or AGEs. AGE accumulation can damage small blood vessels in the eyes, kidneys, and that support the nerves in our extremities. This mechanism of damage is present across the spectrum of serious diabetic complications as well as cardiovascular disease and neurodegeneration.
The Amadorins, developed through a proprietary assay, inhibit AGE formation at its earliest stages. By interrupting the cascade at the first step of oxidative breakdown, Amadorins offer the greatest promise of protection by limiting disease progression. As we optimized our candidates for future clinical utility, we improved potency, safety, and pharmacological properties.
For the millions of people living with diabetes, the Amadorins were developed to halt disease progression, rather than manage symptoms.
PimoxIV for COVID-19 Acute Kidney Injury
Under IND# 143,097, PIMOXIV (pyridoxamine dihydrochloride) is an intravenous formulation to protect patients from acute kidney injury (AKI) following cardiac surgery. Praetego is encouraged by FDA communications in support of a program revision to COVID-19 AKI.
PimoxIV’s active ingredient, pyridoxamine, effectively inhibits a cascade of pathogenic oxidative chemistries that develops in patients with diabetes and lead to irreversible kidney damage. These same chemistries have been observed in acute kidney injury (AKI). For patients with comorbidities such as diabetes at increased risk of COVID-19 complications, PimoxIV is a clinic-ready candidate that could mitigate the risks to this patient population.
Diabetic Peripheral Neuropathy (DPN)
DPN is the damage that effects the nerves in the hands and feet of diabetics. About 50% of diabetics develop DPN. For many it eventually causes pain. Praetego’s Amadorins target the cause of the damage.
In a proof of concept study using a standard animal model of DPN, the Amadorins restored nerve function. They reversed nerve deficits in both large and small nerve fibers. Over the series of Amadorins tested, we confirmed that stronger AGE inhibition meant greater potency in the preclinical model of diabetic peripheral neuropathy. In preclinical safety studies, the Amadorins demonstrated a wide therapeutic window and minimal off-target hits.
Other Serious Diabetic Complications
Beyond DPN, we are targeting Cognitive Decline, Nephropathy (Chronic Kidney Disease) and other serious diabetic complications.
Praetego was founded in 2017 in Durham, North Carolina.
CEO & Co-Founder
Pepper Landson is a 28-year pharma veteran. She has a proven record of creating value in early stage companies. Combining her skills in business development and operations with an extensive drug development background, she is ideally suited to her role. She has worked exclusively on the Amadorin technology and diabetic complications for the last 8 years.
Raja G. Khalifah, PhD
Chief Scientific Officer
Raja G. Khalifah, PhD, is a broadly trained chemist and biochemist who transitioned from academia to directing research at three startups founded on discoveries from his research. Experienced in medicinal chemistry and drug design, pharmacokinetics and drug metabolism, and preclinical and clinical studies. Primary co-inventor on 15 issued US patents in Amadorins and related fields.
Peter C. Johnson, MD
Chief Medical Officer
Peter C. Johnson, MD, is both an accomplished surgeon and clinical researcher. His career is complemented by successful entrepreneurial endeavors in the space of regenerative medicine and biomedical technology.
Paul A. Boyer
Chief Financial Officer
Paul A. Boyer is seasoned financial executive with experience in the field of diabetes. He is a proven value creator in start-ups, high-growth, and VC/private equity ventures for public & private companies. He has executed ~$1B in public & private equity & debt, including a successful IPO. He also developed/orchestrated 16 M&A’s.
Rayaz Malik, MD, PhD
Weill Cornell School of Medicine
Peter McCullough, MD, MPH
Baylor University Medical Center
George Bakris, MD
Nephropathy & Hypertension
University of Chicago
Jamie Dwyer, MD
Vanderbilt University Medical Center
Alexander ‘Zan’ Fleming, MD
Metabolic Disease & Regulatory Strategy
Former head of the Division of Metabolic and Endocrinology Products, U.S. FDA
Praetego submits a $2.5M Phase 2 grant to NIH/NIDDK
January 2, 2020
After a successful conclusion of the Phase 1 NIDDK grant, Praetego submits a Phase 2 SBIR/STTR grant to continue preclinical development of novel Amadorins against Diabetic Peripheral Neuropathy. This award would provide preclinical proof of concept in multiple animal models of Type 1 and Type 2 diabetic neuropathy.