Phase 3 Clinical Stage

Treatments for neglected diseases.

Zero Point Five Therapeutics, Inc. is developing safe and efficacious therapeutic interventions for diseases that have been historically overlooked by mainstream medicine.

N. AMERICAS. AMERICAEUROPEAFRICAS. ASIAE. ASIASE ASIAAUSTRALIAHigh burdenModerate burdenLow / at riskActive hotspotSource: WHOSTH ENDEMIC REGIONS โ€” GLOBAL BURDEN
1B+NTD-Affected People
2BSTH Infections Worldwide
149Countries with Endemic NTDs

Science in service of the overlooked.

Neglected diseases disproportionately affect billions of people in low- and middle-income communities, yet they receive a fraction of global pharmaceutical research and development investment. The gap between need and resource is one of the most pressing inequities in modern medicine.

At Zero Point Five Therapeutics, Inc., we are committed to closing that gap โ€” and we have moved beyond early research to the frontlines of clinical validation. Our lead program is now in Phase 3 clinical trials, combining rigorous scientific methodology with a genuine moral urgency to deliver therapeutic solutions that are both safe and highly effective for populations that have been left behind.

"Developing safe and efficacious treatments for neglected diseases is not just a scientific challenge โ€” it is a moral imperative."

Where our science is directed.

01

Neglected Tropical Diseases

Targeting parasitic and bacterial infections that afflict hundreds of millions in tropical and subtropical regions with limited access to existing treatments.

02

Rare & Orphan Conditions

Addressing conditions that affect small patient populations, where the commercial incentive has historically been insufficient to attract pharmaceutical investment.

03

Drug-Resistant Infections

Developing novel therapeutic strategies to combat the global threat of antimicrobial resistance, which disproportionately impacts resource-limited healthcare settings.

Phase 3. The final mile.

Preclinical
Target ID & Lead Opt.
Phase 1
Safety & PK
Phase 2
Proof of Concept
Phase 3 Active
Pivotal Trial
NDA / BLA
Regulatory Filing
Approval
Market Access
โœ“ Complete
โœ“ Complete
โœ“ Complete
โ— In Progress
Upcoming
Upcoming

Lead program currently enrolling in Phase 3 pivotal trial across multiple international clinical sites.

ZP5-9676

Phase 3
Soil-Transmitted HelminthiasisEnrolling

Lead therapeutic candidate for soil-transmitted helminth (STH) infections, currently enrolling in a Phase 3 pivotal trial across multiple international clinical sites. Granted both Orphan Drug Designation and Rare Pediatric Disease Designation by the FDA.

Recognized at every level
of regulatory priority.

FDA Designation

Rare Pediatric Disease Designation

Granted by the FDA in recognition of the serious and life-threatening nature of the condition in patients aged 18 and under. This designation provides eligibility for a Priority Review Voucher upon approval โ€” a significant commercial and humanitarian milestone.

FDA Designation

Orphan Drug Designation

Awarded by the FDA's Office of Orphan Products Development for our lead therapeutic candidate. This designation confers seven years of market exclusivity upon approval, tax credits for qualified clinical trials, and waiver of the Prescription Drug User Fee Act application fee.

The team behind
the science.

ZP5 Therapeutics was co-founded by two industry veterans who previously built and sold a company together โ€” bringing decades of combined experience in drug development, regulatory affairs, and clinical pharmacology to one of global health's most pressing problems.

Joseph Amprey, CEO and Founder of ZP5 Therapeutics
Joseph Amprey, MD, PhD
CEO & Founder
Cornell Weill / UPenn BiochemistryNIH MSTPSymbiomix Co-FounderMedImmune Ventures ($300M)

Dr. Amprey has been in health care for over 23 years, combining clinical training, venture capital, and executive leadership across multiple successful biotech ventures. Most recently, he was VP and Head of US Medical Affairs at Lupin Pharmaceuticals, playing a key role in the launch of Solosec for the US market.

Prior to Lupin, he co-founded Symbiomix Therapeutics โ€” a venture-backed company acquired by Lupin Pharmaceuticals in 2017 after achieving NDA approval for Solosecโ„ข โ€” serving as Chief Business Officer and Head of Medical Affairs. He also co-founded Zyngenia, an antibody-based drug development company focused on breast cancer and autoimmune diseases.

Dr. Amprey's passion for drug development was shaped by his earlier career as a venture capitalist. He ran MedImmune Ventures, a $300M corporate venture fund that became the corporate venture arm of AstraZeneca during his tenure. Dr. Amprey completed his internship in internal medicine through a joint residency at New York-Presbyterian Hospital and Memorial Sloan-Kettering Cancer Center. He earned his B.S. in Biochemistry from the University of Pennsylvania and received both a Doctorate of Immunology and a Medical Degree from Cornell University's Weill Medical College through the NIH-funded MSTP program, with additional graduate training from Harvard's Brigham and Women's Hospital and the Albert Einstein College of Medicine.

Helen Pentikis, CSO and Founder of ZP5 Therapeutics
Helen Pentikis, PhD
CSO & Founder
25+ Years Drug Development75+ FDA Regulatory Meetings150+ Clinical Studies80+ Publications

Dr. Pentikis brings more than 25 years of experience in the development of new drugs and therapeutics. She has represented scientific interests in pharmacology/toxicology, clinical pharmacology, biopharmaceutics, and regulatory strategy across more than 75 FDA regulatory meetings, and has been involved in more than 150 clinical studies in adult and pediatric patients spanning Phase 1โ€“3 โ€” with deep expertise in anti-infectives, women's health, CNS, oncology, and oncology supportive care.

She co-founded Symbiomix Therapeutics as CSO, leading the scientific strategy through its acquisition by Lupin Pharmaceuticals in 2017 following NDA approval for Solosecโ„ข. Prior to Symbiomix, she served as Head of Clinical Pharmacology at AkaRx Inc., where her work on the senior management team contributed to the company's $300M acquisition. Dr. Pentikis has also served as Global VP of Pharmacokinetics and Pharmacodynamics at ICON plc, as a Senior Research Fellow at Sanofi-Aventis, and as an FDA Reviewer in the Office of Clinical Pharmacology.

She holds a B.S. in Biology from Wake Forest University, a Ph.D. in Pharmacology and Toxicology from the University of Maryland, and completed a Pharmacokinetics Fellowship at the FDA. She serves as a grant reviewer for the Maryland Innovation Initiative and has served on the boards of Metrum Research Group and Redivivus Therapeutics.

Want to learn more about
Zero Point Five Therapeutics?

Whether you're a potential partner, researcher, or investor, we'd love to share what we're working on and explore how we might work together toward better treatments for neglected diseases.

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