Pyramid Biosciences Announces First Patients Dosed in Phase 1 Clinical Program for Dermatology

• PBI-100 is a topical treatment being developed for people living with mild to moderate psoriasis
• PBI-100 is a highly-selective tropomyosin receptor kinase (TRK) inhibitor
• Psoriasis affects more than 120 million people worldwide, nearly eight million in US

WALTHAM, Mass.--(BUSINESS WIRE)--Pyramid Biosciences, Inc., a clinical-stage, biotechnology company developing novel precision therapies, announced that it has commenced a Phase 1 clinical study for its therapeutic candidate PBI-100, a first-in-class topical treatment targeting mild to moderate psoriasis in patients. Psoriasis is an immune-mediated skin disease¹, where an overactive immune system causes a rapid increase in keratinocyte production that can lead to raised, flaking skin lesions. People living with psoriasis report symptoms such as itching, burning and stinging.²

“Dosing our first patient is an important milestone for Pyramid Biosciences, physicians, and most importantly, patients suffering from psoriasis and other inflammatory skin disorders,” said Kollol Pal, PhD, co-founder, and CEO of Pyramid Biosciences. “We expect that PBI-100 will offer benefit for many patients currently suffering without an effective treatment option.”

Inflammatory skin diseases are one of the leading causes of global disease burden. Psoriasis affects approximately 125 million people globally³, and topical treatments remain one of the mainstays of current medical treatment. In the United States, psoriasis affects nearly eight million people.⁴

PBI-100, a highly-selective TRK kinase inhibitor, provides a novel mechanism of action for the treatment of psoriasis and targets both the psoriatic lesions as well as related symptoms including itch. Pyramid Biosciences plans to conduct further clinical testing of PBI-100 for use in additional indications.

The Phase 1 study is recruiting healthy volunteers to assess the safety and tolerability of multiple dose levels of PBI-100. The single arm, blinded, randomized, controlled study is based in the U.S. and will enroll 25 people in its first round. Additional information can be found at https://www.clinicaltrials.gov/ (Reference: NCT04882631).

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^1	Rodrigo Valdes-Rodriguez, M.D., Shawn G. Kwatra, M.D., Gil Yosipovitch, M.D. (2018). Itch in Psoriasis: From Basic Mechanisms to Practical Treatments. Psoriasis Forum, Volume: 18a issue: 3,page(s): 110-117.
^2	National Psoriasis Foundation: https://www.psoriasis.org/
^3	World Psoriasis Day Consortium, The International Federation of Psoriasis Associations (IFPA): https://ifpa-pso.com/
^4	Rachakonda et al., JAAD 2014. DOI: https://doi.org/10.1016/j.jaad.2013.11.013

About Pyramid Biosciences Inc.

Pyramid Biosciences is clinical stage, biotechnology company dedicated to developing a portfolio of novel precision therapies targeting a wide range of molecularly defined diseases. Pyramid is currently in clinical development of two highly selective tropomyosin receptor kinase (TRK) inhibitors. For more information, please visit www.pyramidbio.com.