Novel Lipids Pharmacognosy Solutions

Novel Lipids Pharmacognosy Solutions

Peskin Pharmaceuticals® — The Clinical Stage World Leaders in Optimizing Patient Outcomes For Those Suffering From An Impaired ∆-6 Desaturase Metabolic Pathway.

IND PSK003 for Drug-Resistant Hypertension

A significant space with unmet medical need utilizing Coronary Artery Calcium (CAC) as a secondary endpoint

Hypertension is the world’s #1 PREVENTABLE killer for premature death and cardiovascular disease.

New treatments for resistant hypertension are highly needed, considering the disastrous complications of the disease.

Ingestible PSK003 Investigational New Drug (IND) Takes Center Stage.

Although we have a very strong team of consultants, typically, in drug development, the pharmaceutical team takes center stage, but not in our case. We have strong anecdotal evidence of PSK003’s high effectiveness in reducing systolic blood pressure in hypertensive patients. PSK003 also possesses a platform effective in multiple indications. PSK003 is fully developed, ready for FDA Phase 2 dosing study, leading to a P3 IND submission. Furthermore, we reduce overhead via our existing relationships with multiple high-level consultants on an “as needed” basis (See below).

Primary Endpoint Rationale: Atherosclerotic hypertension is associated with increased risk of events.

  • Drug-Resistant Hypertension: Resistant hypertension (defined as blood pressure above 140/90 mmHg despite using 3 or more medications at optimal doses) affects about 10% to 15% of all treated hypertensive adults. Among diabetic patients, the prevalence of true resistant hypertension is estimated to be considerably higher, ranging between 15% and nearly 30%, depending on age and kidney functionality. The potential market is millions of patients – blockbuster potential. We are working with the FDA for a physician-sponsored Phase IIb clinical trial.

Over 20 Years of R&D in the Cardiovascular Space

Before receiving additional outside funding, we have over 20 years of privately funded (by Peskin) R&D research in the cardiovascular / atherosclerosis space leading to an advanced more effective patented composition — 4+ years in the marketplace as a Medical Food (EZtrek®), giving us a unique ability to see Human Outcomes in various spaces; in particular, atherosclerosis / hypertension / CVD. Although small sample sizes, these results in HUMAN are significantly superior to typical unreliable rodent studies.

Peskin Pharmaceuticals® was founded to research, develop, and ultimately commercialize therapeutics for disorders of the ∆-6 metabolic pathway leading to increased inflammation. Today, many people’s diets unknowingly may cause chronic inflammation leading to ill-health. As we age, this pathway is known to become impaired. Eicosanoid (Highly powerful EFA-derivatives) optimization starts with the ∆-6 metabolic pathway.

With over 25 years of dedicated research, we are the world leaders in this space. Applying unique insights into the epigenetic pathways, our approach focuses on state-of-the-art research — based on recognized scientific principles and supported extensively in the scientific literature.

Primary Indication

Drug-Resistant Hypertension

Atherosclerosis is now recognized as a chronic inflammatory condition, not simply a lipid storage disease, in which cells from both innate and adaptive immunity are involved in its pathogenesis. This inflammation induces microcalcification, leading to the formation of arterial plaques, which may go undetected for many years, ultimately resulting in severe or fatal cardiovascular events, including hypertension / drug-resistant hypertension, and CAC deposition.

African Americans and Hispanics are the 2 largest ethnicities for atherosclerosis. The diabetic patient space is significant. Overall, approximately 2 in 3 diabetics (39 million diagnosed diabetics) are hypertensive.

A standard target BP of 130/80 mm Hg is the target in patients with diabetes mellitus who have high-risk clinical features, including one or more risk factors such as CVD, subclinical organ damage, and stage 3 or worse chronic kidney disease.

Approx. 30% of hypertensive diabetic adults have apparent treatment-resistant hypertension. (Ref.: RESEARCH — JULY 7, 2026, AstraZeneca’s Baxfendy set for blockbuster sales after hypertension approval.)

In the US, apparent treatment-resistant hypertension (aTRH) affects approximately 12% to nearly 20% of adults1 — defined as currently taking 3-4 medications for high blood pressure (specified as: > 140 mmHg / > 90 mmHg for most adults and > 130/80 for diabetic adults or patients with chronic kidney disease). This translates to about 10.3 million potential treatment-resistant patients.

The rate of true resistant hypertension drops to about 5% of all hypertensive patients (when considering medication non-adherence and “white coat” effects) — A significant number of patients (millions) — blockbuster potential.

1 Carey, RM, et al., “Prevalence of Apparent Treatment-Resistant Hypertension in the United States: Comparison of the 2008 and 2018 American Heart Association Scientific Statements on Resistant Hypertension,” Hypertension. 2019;73:434-431. Vol 73, Issue 2, 2019, 424-431.

Peskin Pharmaceuticals proposes an IND for a promising new 1st-in-class drug that uniquely targets a root cause of inflammation. The delta-6 metabolic pathway is often significantly impaired in these patients and leads to decreased output of the body’s powerful anti-inflammatory PGE1. Uniquely, PSK003 doesn’t block or impede. PSK003 naturally maximizes the body’s output of PGE1. This allows for few, if any, adverse effects, leading to increased compliance / increased sales.

Because of PSK003’s status as a Medical Food, we uniquely have anecdotal, highly promising results for PSK003’s effectiveness IN HUMANS in reducing blood pressure, both as measured by patients using blood cuff measurement and in physician offices using Medicore’s FDA-cleared stiff artery evaluation software.

A 4-pt drop (P<=0.05) in systolic BP has been accepted by the FDA for a new drug (i.e., Tryvio). Therefore, we are highly confident that PSK003 will acceptably reduce blood pressure across diverse patient groups, including diabetics and many drug-resistant hypertensives.

Secondary Indication

Impeding / Reversing Coronary Artery Calcium (CAC)

Now known to increase hypertension.

While the older literature didn’t support a cause / effect relationship that increasing CAC increases systolic blood pressure, a 2019 study challenges this conclusion in the SPRINT trial (Uddin, et al., “The role of coronary artery calcium for stratifying cardiovascular risk in adults with hypertension: The Coronary Artery Calcium Consortium,” Hypertension. 2019; May; 73(5):983-989): CAC risk stratifies adults with hypertension, including those who were in the Systolic Eligible Intervention Trial (SPRINT) from 16,000 patients from CAC Consortium. This association was very strong, and Peskin Pharmaceuticals agrees that more inflammation-based arterial calcium MUST equate to increased arterial stiffness (greater “balloon-like” flexibility with PSK003 vs stiffer and “straw-like” without PSK003).

We have promising anecdotal evidence of PSK003 Precursor and PSK003 itself in impeding the progression / reversing existing CAC. The FDA does not currently accept CAC as a surrogate for atherosclerosis. However, the evidence is overwhelming that CAC warrants surrogate status (Commissioned by Peskin Pharmaceuticals, “Evaluation and Comparison of Coronary Artery Calcium (CAC), as measured by Agatston Score and Calcified Plaque Volume (CPV), as Surrogate Endpoints of Coronary Artery Disease/Atherosclerosis (CADA),” makes it crystal clear that CAC is highly predictive in risk stratification for future atherosclerotic-based events. (Available on request.))

Because of PSK003’s unique anti-inflammatory pathway, we are highly confident that in addition to lowering blood pressure in these drug-resistant individuals, PSK003 will also lower CAC. This unique additional benefit further differentiates PSK003 from other drugs. Today, most cardiologists and other healthcare professionals are aware of the importance of low CAC levels.

30.6%Relative net difference between PRECURSOR formulation / NON-PRECURSOR — p<0.05, statistically significant.
−17.4%CAC reversed from their baseline CT scan in medicament pts. (annualized)
+13.2%CAC increased in non-medicament pts. (annualized)

Secondary Endpoint Rationale: Coronary Artery Calcium (CAC) is a highly specific feature of coronary atherosclerosis and is quantitatively determined via non-contrast low-radiation CT scan. While not currently recognized by the FDA as an atherosclerotic surrogate, CAC scoring is ACC/AHA guideline-endorsed to improve cardiovascular risk assessment in asymptomatic individuals at intermediate risk to guide use of preventive therapies and has been used to stratify mortality risk in hypertensive patients. There are currently no approved drugs to treat the progression of CAC. Surprisingly, long-term statin use is now known to paradoxically increase CAC, thereby significantly increasing the potential market for PSK003.

Given that statins are the most common drug class in America, with more than 25% of adults taking them (> 35 million patients), it is clear that treatments impeding CAC progression represent a significant unmet medical need. PSK003 has the potential to plausibly slow or reverse the progression of CAC, thus reducing the risk of serious atherosclerotic-based outcomes, a leading cause of death.

Because of the significant unmet medical need for treatment of CAC progression, Peskin Pharmaceuticals is confident that a full clinical development of PSK003 would translate into a breakthrough treatment in the CAC space. CAC is now known as the #1 predictor of future events (FDA CAC petition available on request). Per journal articles, typical Coronary Artery Calcium (CAC) increases yearly @ 20-25% in the general population. There are no current drugs to impede the progression or reverse CAC.

Success would give us the unique advantage of lowering blood pressure in this patient population AND impeding the progression / reversing existing CAC. Additionally, PSK003 is projected to also lower LDL-C (Dr. G. Robb, former chair, Dept. of Plastic / Reconstructive Surgery, MD Anderson Cancer Center). These 3 hallmarks give PSK003 a distinctive advantage.

Although small and independent, Peskin Pharmaceuticals has advanced to fully developed ingestible drug status — IND PSK003, with patents for North America, takes center stage. PSK003 significantly improves a previously unexploited metabolic pathway — increasing impaired delta-6 desaturase metabolic pathway output to maximize PGE1 — the body’s powerful natural anti-inflammatory. We now know that lipids control proteins like cytokines. This new understanding allows for potential new 1st-in-class drug status in the atherosclerotic space, i.e., drug-resistant hypertension reversal.

Our business model utilizes consultants on an “as needed” basis. Meet the team of consultants. This keeps overhead / “burn rate” extremely low.

Strong IP

Evolution of PSK003 — Inflammation / CAC Minimized

  1. 2004

    Precursors

    20 Years in Marketplace

  2. 2010

    Further Refinements

    Enhanced Anti-inflammation, Vasodilation & Accelerated Wound Healing

  3. 2022

    PSK003

    Investigational New Drug for Impeding Progression / Reversing CAC

  4. 2026

    PSK003

    Investigational New Drug for Treating Drug-Resistant Hypertension

Eicosanoid Optimization chart: omega-3 and omega-6 families and the delta-6 desaturase pathway. Lipids are a modifiable variable in tissue composition.

The culmination of over 2 decades of research led to developing a plant-based lipids composition (Medical Food) to help improve inflammation-related problems. This is the formulation for IND PSK003.

Our methodology is unique. We focus on supporting and optimizing the patient’s natural physiologic processes; uniquely not blocking or impeding metabolic pathways. The results are novel and often highly effective.

Peskin Pharmaceuticals® has developed a medical food, EZTREK® — specially for dietary management with distinctive nutritional requirements, helping to compensate for an impaired delta-6 desaturase metabolic pathway, as diagnosed and evaluated by your physician. This patented, botanical-based lipids formulation is not duplicated by normal / typical dietary modification. We are working with the FDA to turn this Medical Food into an ingestible drug.

Medical Food EZTREK®

Medical Food EZTREK®

Decades of Research With Precursors

Corporate: 799 Limpet Drive, Sanibel, Florida 33957 (USA)  |  peskinpharma.com | Phone: +1-713-298-8783