Developing novel serotonergic therapeutics

Praeventix is focused on the development of novel 5-HT7 receptor antagonists as potential treatments for chronic pruritus and other serotonergic-driven disorders such as cocaine use disorder.

About Us

Mission to improve the quality of life for those who suffer from serotonergic-driven disorders

Praeventix is an early development stage biopharmaceutical company committed to the discovery, research and clinical development of novel serotonergic therapeutics with potential applications in dermatologic, autoimmune and neurodegenerative diseases.

Praeventix was founded by Dr. Douglas Pippin based on discoveries he researched at Temple University.

We are initially focused on the development of clinical candidate PRA-523, a potential first-in-class neuromodulatory 5-HT7 receptor antagonist for the treatment of chronic pruritus. In addition, we are researching 5-HT7 modulators for the potential treatment of inflammatory bowel disease (IBD) and cocaine use disorder (CUD).

Potential first indication

Chronic Pruritus

Pruritus, the urge to scratch due to an unpleasant sensation, is a symptom of many diseases and the most common skin complaint in dermatology

Prevalence

Chronic pruritus (>6 weeks) has an estimated lifetime prevalence of >20% in the general population

Chronic Itch Drivers

Serotonin is a central mediator; transduction of itch occurs along serotonergic sensory afferent neurons in the skin

Patient Impact

Affects sleep, mood, personal relationships and can significantly reduce quality of life, similar to chronic pain 

Unmet Need

Global health concern; limited therapeutic options that require long treatment durations to achieve minimal itch relief 

Unmet need in

Atopic Dermatitis

Chronic pruritus is a trademark symptom of atopic dermatitis (AD), affecting all patients regardless of age and disease severity

Prevalence

~20% of children and up to 10% of adults suffer from AD


Characteristics

Chronic inflammatory skin disease; itchy skin lesions and rashes; scratching leads to 2° lesions and worsening pruritus 

Patient Impact

~37% of AD patients with clear or almost clear skin still have moderate to very severe itch 

Unmet Need

Anti-inflammatory agents used to treat AD do not target itch pathways and do not provide rapid, sustainable itch relief 

Lead Molecule

PRA-523

Shuts down itch

Our initial focus is on the development of topical clinical candidate PRA-523, a neuromodulatory 5-HT7 receptor antagonist, as a potential first-in-class treatment for chronic pruritus.

  • Highly potent, selective 5-HT7 antagonist
  • Dose-dependent itch reduction (chronic AD model)
  • Rapid onset
  • Peripherally restricted pharmacokinetic profiles
  • Ideal dermal penetration/permeability
  • Clean safety pharmacology and toxicity profile

Serotonin (5-HT) plays a central role in driving chronic itch, promoting barrier dysfunction and heightened inflammation. Studies have shown that 5-HT is a contributing factor to the severity of chronic pruritus, and elevated levels of 5-HT have been reported in patients with AD and chronic eczema.

Current AD treatments largely inhibit inflammatory pathways, leaving itch unresolved. PRA-523 acts directly on serotonergic afferent nerves in the skin, targeting the itch pathways and making it ideal for topical administration. Our approach to blocking 5-HT7 activation with a selective 5-HT7 antagonist has the potential to offer a first-in-class treatment for the management of chronic pruritus in AD and other serotonergic-driven disorders.

Our Pipeline

Pursuing novel serotonergic therapeutics

Chronic pruritus: Itch lasting >6 weeks, or chronic pruritus, has an estimated lifetime prevalence of >20% in the general population. Transduction of itch occurs along serotonergic sensory afferent neurons in the skin (vs. histaminergic neurons driving acute itch).

Inflammatory bowel disease (IBD): Over 2MM Americans suffer from IBD, which causes severe, chronic gastrointestinal inflammation. While much of IBD pathophysiology remains unexplained, it is well documented that the innate and adaptive immune systems play major roles.

Cocaine Use Disorder (CUD): In 2021, 1.4MM people in the US over the age of 12 suffered from CUD in the past year. Cocaine prevents dopamine (DA) uptake by dopamine transporters (DAT) and interferes with the normal operation of the mesocorticolimbic dopamine (MCL-DA) system, also known as the reward system Cocaine also blocks norepinephrine and serotonin transporters, and there is substantial interplay between 5-HT signaling and MCL-DA activity.

Our Team

Experienced leadership committed to developing our novel pipeline

Lonnie Moulder

Mr. Moulder (Executive Chair) is the Managing Member of Tellus BioVentures, a life sciences investment fund, and the Chief Executive Officer and Chairman of Zenas BioPharma. Prior to establishing Tellus, Mr. Moulder co-founded TESARO and served as Chief Executive Officer and Director until its acquisition by GlaxoSmithKline. He previously served as President and Chief Executive Officer of Abraxis BioScience. Prior to Abraxis, he served as Vice Chairman of Eisai Corporation of North America following Eisai’s acquisition of MGI PHARMA, where he served as President and Chief Executive Officer. This followed him serving as a member of the founding management team of a venture-stage biotech company. Mr. Moulder began his career as a clinical pharmacist followed by a 17-year career at predecessor companies of Sanofi, beginning with Marion Laboratories.

Mr. Moulder is a Temple University Trustee and a Council Member for both the University of Chicago Booth School of Business and the Polsky Center for Entrepreneurship and Innovation. He serves on the Board of Directors for Zai Lab and Helsinn Group and for the Tellus BioVentures portfolio companies: Aegle Therapeutics, Interius BioTherapeutics, Navrogen, Praeventix, Vittoria and Zenas BioPharma. Mr. Moulder received a Pharmacy degree from Temple University and an M.B.A from The University of Chicago Booth School of Business.

Heidi Kempinski

Ms. Kempinski (CEO) is a seasoned biopharmaceutical executive with over 30 years of experience in global drug development and organizational build, spanning discovery to commercialization. Ms. Kempinski has successfully built and led integrated R&D operations for companies of variable size and maturity. Her experience includes the development of large and small molecules and cell and gene therapy products, spanning all development stages through to commercialization.

Ms. Kempinski also serves as Senior Principal and Operating Executive at Tellus BioVentures, a life sciences investment fund, and Chief Operating Officer for Aegle Therapeutics, a Tellus Portfolio company. Previously, she also served as Chief Operating Officer for Zenas BioPharma, a Tellus portfolio company, where she built the R&D organization from the ground to over 50 employees in 2 countries and built and managed a portfolio of 6 IND/clinical stage products.  Prior to Tellus, Ms. Kempinski served as VP of Business Operations and Strategic Alliances at GlaxoSmithKline following the acquisition of TESARO in 2019.  Ms. Kempinski was part of the founding management team of TESARO where she established pharmaceutical development and manufacturing, quality, regulatory, clinical operations, and program management for the company, ultimately leading to multiple, successful development programs, regulatory approvals in >30 countries and product launches in the US and EU. Ms. Kempinski brings fundraising experience through the generation of corporate strategic plans, investor pitch decks, and supporting investor diligence processes resulting in over $200M Series A-B financing, and the successful acquisition of 3 of her prior companies for a total of $9B. 

Dr. Douglas Pippin

Dr. Pippin, PhD (President & Founder, PI) is a scientist, educator, serial biotechnology entrepreneur and corporate executive with deep expertise in drug development. He brings over 20 years of experience in discovering and developing novel therapeutics across a range of areas. Dr. Pippin’s track record of success includes serving in key roles to close a $500M deal with Genentech to discover, develop, manufacture, and commercialize therapeutics and selling Cellular Genomics, Inc. to Gilead, Inc. for $120M. As the Founding CEO of Praeventix, Dr. Pippin successfully raised $13.6M of funding through non-dilutive competitive grant awards (NIH), public-private partnerships (Temple University School of Pharmacy), and private investment funds (Tellus BioVentures). Over the years, Dr. Pippin’s research group efforts have led to the discovery of 3 clinical candidates, one FDA approved OTC Eczema/anti-pruritic treatment, two follow-on candidates currently in IND enabling studies for AD/pruritus, and numerous late-stage pre-clinical candidates, including symptomatic and disease modifying treatments for arthritis (pre-clinical and clinical), ovarian cancer (Phase II), lung cancer (Phase I), and Lymphoma (Phase II). Dr. Pippin’s discovery efforts over the last five years have been focused primarily on identifying and commercializing novel therapeutic candidates for Pruritus/Inflammation/Addiction/Immunology (Serotonin signaling modulators and Sphingosine-1-Phosphate lyase modulators). Dr. Pippin’s work designing ligands targeting the serotonergic receptor 5-HT7 has led to the discovery of Praeventix’s novel selective lead candidate PRA-523 as a potential first-in-class topical treatment for pruritus.

Contact Us

Get in touch

Praeventix, Inc.
665 Stockton Drive, Suite 200H
Exton, PA 19341