Atticus in the News
Atticus Pharma is a therapeutics company developing drugs for immunodermatology and associated diseases. Our two initial programs are for the treatment of cutaneous lupus lesions and androgenic alopecia. Atticus licensed from Zylö Therapeutics the Z-pod® sustained-release technology that originated at Albert Einstein College of Medicine that was further developed at Zylö. The technology provides a depot-like effect and enables delivery of therapeutic agents (small molecules, peptides, siRNA) in a sustained-release manner.
Atticus Pharma Awarded $2 Million NIH Phase II SBIR Grant to Advance Cutaneous Lupus Drug Candidate
Funding supports development of ATC-001, a Z-pod®-based anandamide formulation for local delivery to cutaneous lupus lesions
GREENVILLE, SC, UNITED STATES, September 23, 2026 /EINPresswire.com/ -- Atticus Pharma Inc., a therapeutics company developing novel medicines using its topical, sustained-release drug delivery platform, received a Notice of Award for a $2 million Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Arthritis and Musculoskeletal and Skin
Diseases, part of the NIH.
The grant will support further development of an endocannabinoid microparticle formulation for the topical treatment of cutaneous manifestations of lupus erythematosus, building on positive data from multiple animal models of lupus that showed resolution of lesions and dramatic improvements in skin and histopathology scores. Preclinical development work, including manufacturing scale-up and other IND-enabling studies, will be supported by the grant. These Phase II studies, along with prior Phase I work, are conducted in collaboration with Victoria P. Werth, M.D., professor of dermatology at the Hospital of the University of Pennsylvania and the Veteran's Administration Medical Center.
Cutaneous lupus is an autoimmune skin condition characterized by lesions that are itchy and inflamed, oftentimes causing permanent scars. There is currently no FDA-approved therapeutic for this condition. Atticus’s topical approach delivers the drug directly to the lesion, reducing systemic exposure and potentially minimizing associated side effects.
“This award enables us to advance an important new therapeutic candidate for a condition that currently has no approved therapy. Patients with these lupus lesions are currently treated with
steroids and off-label use of other drugs that have potentially serious side effects. Our sustained-release, topical approach is designed to provide a safer, more effective treatment option,” said Leigh Hsu, Ph.D., CEO and co-founder of Atticus Pharma. He added, “We have - just in the last month - received more than $4M in non-dilutive SBIR funding to advance our topical therapeutic drug candidates. This validation from the NIH underscores the advantages of our technology and the need for new approaches to treat serious medical conditions.”
For the innovation communities in Greenville, where Atticus is headquartered, and in San Diego, where key personnel are located, the award represents another example of federal research
funding helping a local biotechnology company advance technology toward commercialization while preserving equity for future growth.
Atticus Pharma Awarded $2 Million NIH Phase II SBIR Grant to Advance Topical ED Treatment
Funding supports development of a Z-pod®-based sildenafil formulation designed to improve localized delivery while reducing systemic exposure.
GREENVILLE, SC and SAN DIEGO, CA, August 24, 2026 — Atticus Pharma Inc., a therapeutics company developing novel medicines using its topical, sustained-release drug delivery platform has received a Notice of Award for a $2 million Phase II Small Business Innovation Research grant from the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH.
The grant will support optimization of a Z-pod-based topical PDE5i formulation for treatment of erectile dysfunction (ED), building on successful work completed under a Phase I SBIR that showed Atticus’s novel product candidate demonstrated significant efficacy in a model of ED secondary to aging.
The Phase II funding allows Atticus not only to continue optimizing the formulation, but to advance the novel drug candidate in diabetes-related ED and to assess its application in recovery post radical prostatectomy. Both the prior Phase I work and this prospective Phase II work will be conducted in collaboration with Kelvin Davies, Ph.D. from the Department of Urology, Albert Einstein College of Medicine.
Phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, are administered orally, exposing the patient systemically, which can result in myriad side effects such as headache, facial flushing, and vision and hearing loss. Atticus’s topical approach delivers the drug locally, reducing systemic exposure and potentially decreasing associated side effects, while maintaining therapeutic benefit.
“This award gives us the opportunity to advance an important new application of our delivery technology while building on the encouraging work completed during Phase I,” said Leigh Hsu, Ph.D., CEO and co-founder of Atticus Pharma. “We see significant potential in localized drug delivery for this program and, importantly, in other therapeutic areas where improving how and where a drug is delivered can meaningfully improve the treatment experience.”
For the innovation communities in Greenville, where Atticus is headquartered, and San Diego the award represents another example of federal research funding helping a local biotechnology company advance technology toward commercialization while preserving equity for future growth.
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Atticus Pharma Announces Clinical Data for ATC-002, a Pharmaceutical Product Candidate for Androgenic Alopecia
GREENVILLE, SC, UNITED STATES, February 11, 2026 /EINPresswire.com/ --
• ATC-002 is a topical treatment designed to stimulate new hair growth in subjects with androgenic alopecia.
• ATC-002 uses Atticus’s proprietary Z-pod® technology to create a drug depot in the hair follicle and stratum corneum to deliver drug in a sustained-release manner.
• ATC-002 was evaluated in a cosmetic claims substantiation clinical trial in a 6-month, 3-arm, randomized, double-blind study in 98 women in the U.S.
• This First-in-Human study provided clear evidence of therapeutic effect and unremarkable safety and tolerability, both supporting continued clinical development.
Atticus Pharma Inc., a therapeutics company focused on immunodermatology and other skin disorders, today announced data from a clinical study of ATC-002 in females with androgenic alopecia. ATC-002 is a proprietary product candidate that delivers a mitochondrial-activating molecule using Atticus’s Z-pod sustained-release technology.
The study was a 6-month, 3-arm, randomized, double-blind study in 98 women in the U.S. Subjects were randomly assigned to receive: (i) a low dose of ATC-002, (ii) a high dose of ATC-002, or (iii) Z-pod alone. The main objectives of the study were to assess systemic safety and local tolerability as well as exploring dose response and subject baseline characteristics associated with optimal therapeutic response.
Overall, all study treatments were safe and well tolerated. Topical application of ATC-002 was associated with terminal hair growth at both doses. In particular, the high dose resulted in a mean increase of 13.8 hairs/cm2 in subjects with more hair loss as measured by vellus to terminal hair ratios. The increase in hair growth continued between the 3-month and the final 6-month timepoints, suggesting that future trials of longer duration will show even greater gains. Importantly, the study subject’s global satisfaction questionnaire was highly consistent with the objective hair count findings.
“Demonstrating significant new hair growth in androgenic alopecia subjects that had a challenging baseline ratio of vellus to terminal hair is exciting,” said Atticus CEO, Leigh Hsu, Ph.D. “We are extremely pleased with the findings from this study as they inform the next stage of clinical development and supports a clear regulatory pathway for a future Rx that can treat a condition affecting 80 million Americans.” Hsu added, “It’s also very encouraging that ATC-002 safety and tolerability were unremarkable because drugs for androgenic alopecia are generally used long-term, so a clean safety profile is critical to assure treatment compliance.”
Atticus Pharma Completes Enrollment in the First Human Clinical Trial of ATC-002 for Androgenic Alopecia
Greenville, South Carolina, June 16, 2025 – Atticus Pharma Inc., a therapeutics company focused on immunodermatology and associated conditions, today announced completion of subject enrollment in the human clinical study of ATC-002 in females diagnosed with androgenic alopecia. As planned, a total of 96 subjects were enrolled and randomly assigned to receive: (i) a low dose of ATC-002, (ii) a high dose of ATC-002, or (iii) Z-pod alone.
ATC-002 is a proprietary product candidate that delivers a mitochondrial-activating molecule using Atticus’s Z-pod sustained-release technology. Participating subjects will be returning for their interim 90-day efficacy and safety assessments, with the first study readout planned in Q3 later this year and with final data in Q4.
“We are pleased to have met the enrollment target in less than eight weeks,” said Atticus CEO, Leigh Hsu, Ph.D. “The enrollment milestone underscores the tremendous need and commercial market potential for a differentiated treatment for androgenic alopecia, which affects approximately 80 million people in the United States. Due to potential side effects associated with current treatments, women are often left without a good treatment option and positive data from our trial would provide a pathway for future Rx development of a much-needed new
product.”
Atticus Pharma Announces Late-Breaking Presentation of Collaborative Research at the 82nd Annual SID 2025
GREENVILLE, SC, UNITED STATES, May 5, 2025 /EINPresswire.com/ -- Atticus Pharma Inc, a therapeutics company focused on immunodermatology and associated conditions, today announced the presentation of pre-clinical results in a novel murine model of cutaneous lupus. The poster presentation, co-authored by researchers from University of Pennsylvania Perelman School of Medicine, the Philadelphia VA Medical Center, Zylo Therapeutics and Atticus Pharma, will be made at the 2025 Annual Meeting of the Society for Investigational Dermatology, taking place May 7-10, in San Diego, California.
The presentation highlights collaborative research contributing to Atticus’s ATC-001 product candidate for cutaneous lupus erythematosus, now entering IND-enabling studies, with preclinical models and expertise from the University of Pennsylvania and the Philadelphia VAMC and under the guidance of Victoria Werth, M.D.
SID 2025 Presentation Details
• Poster Number: LB1261
• Title: Therapeutic effects of nano-encapsulated anandamide on skin inflammation in a novel PD-1H knock-out lupus mouse model
• Date: Thursday May 8, 2025
• Time: 4:30 – 6:00 p.m. PST
• Location: Hilton San Diego Bayfront, San Diego, California (Indigo Ballroom & Foyer – Floor Level 2)
Atticus Initiates Clinical Study for ATC-002 in Androgenic Alopecia
GREENVILLE - (EIN Presswire) - April 14, 2025. Atticus Pharma Inc, a therapeutics company focused on immunodermatology and associated conditions, today announced the initiation of a human clinical study of ATC-002 in androgenic alopecia. ATC-002 is a proprietary product candidate that delivers a mitochondrial-activating molecule using Atticus’s Z-pod sustained-release technology. Several subjects have been screened and have received ATC-002.
Atticus accepted into NYU's Endless Frontier Labs [EFL] Mentorship Program
Only 78 of over 1,400 applicants accepted into this prestigious program that is designed to optimize each startup’s chance of scaling into a successful company.
