10900 University Blvd
Manassas, VA 20110

Our Mission

Our mission is to develop anti-inflammatory and immune-modulating drugs for treatment of a broad range of inflammatory, autoimmune and infectious diseases

Research & Development


Serpin Pharma is a privately held biotech company with research facilities in Northern Virginia, USA. Serpin’s dedicated and experienced management team is committed to commercializing first-in-class, anti-inflammatory and immune-modulatory peptides for treatment of inflammatory, autoimmune and infectious diseases.


AAT - $700M in sales, potential >>$4B

Alpha-1-antitrypsin (AAT) is the best-characterized, human Serpin and the second most abundant plasma protein. AAT is an acute phase protein and its level increases during inflammation. Its function is to block serine proteases, reducing tissue damage, and to induce production of anti-inflammatory mediators.

There are currently three FDA approved AAT products on the market for treatment of AAT deficiency (Prolastin, Zemaira and Aralast). These products are purified from human plasma and face manufacturing, supply and costs challenges. Nevertheless, their combined annual sales amount to approximately $700M with an estimated market potential exceeding $1.2B. The objective of ongoing clinical trials is to expand the use of AAT to treatment of new onset type I diabetes, cystic fibrosis and graft-versus-host disease, increasing the combined market potential to several billion dollars annually.


Serpin Pharma’s lead drug candidate

SP16, Serpin Pharma’s lead product, is a first-in-class peptide drug derived from AAT. An extensive pre-clinical data package shows SP16 comprises AAT’s anti-inflammatory and immune-modulatory properties, making this readily available peptide a biosuperior to AAT in a range of inflammatory and autoimmune diseases. SP16 targets critical immunological pathways and is predicted to become a paradigm-shift therapeutic for treatment of autoimmune disease, devoid of the non-specifc, detrimental immune suppression side effects caused by other drugs.



SP16 is positioned as a Biosuperior to the marketed AAT drug. Its key advantages over AAT include increased potency, ease of manufacturing, availability, cost, strong and unique IP, and extraordinary benefit to patients and payers



Strategy

The lead indication for SP16 development is new onset type I diabetes, a $2B market with an associated $14.9B in healthcare costs. Type I diabetes is an autoimmune disease resulting in slow, progressive destruction of pancreatic β-cells and development of overt diabetes. Currently, there is no cure for type I diabetes, which is managed with insulin replacement therapy through a course of daily injections. The lead indication was selected based on favorable clinical data from ongoing AAT trials and the promising pre-clinical data obtained with SP16 in mouse models of diabetes.

Concurrently, Serpin Pharma is exploring strategic opportunities for the joint development of two additional IP protected serpin peptides - SP9 and SP14 - as treatment for cystic fibrosis and septic shock in burn patients.