The Californer - Atticus Pharma Awarded Million NIH Phase II SBIR Grant to Advance Cutaneous Lupus Drug Candidate

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Funding supports development of ATC-001, a Z-pod®-based anandamide formulation for local delivery to cutaneous lupus lesions

SAN DIEGO - Californer -- 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 I and II studies 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.

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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 new approaches to treat serious medical conditions."

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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.

About Atticus Pharma. Atticus Pharma was established in 2024 to advance the pharmaceutical applications of the Z-pod® technology. Atticus's two initial product candidates are: ATC-001 for cutaneous lupus, slated to enter clinical trials in 2027; and ATC-002 for androgenic alopecia, which recently completed a human clinical study in 98 women and showed significant new hair growth with no treatment-related serious adverse events. Atticus continues to expand its platform technology capabilities through partnerships with companies that are active in skin and immunodermatological diseases.

Website: www.atticuspharma.com