Pharmability completes GMP release of TIR-C clinical trial material ahead of Phase Ib trial
Pharmability today announced that clinical trial material for its Phase Ib trial of TIR-C in atopic dermatitis has been manufactured and released for clinical use. The material comprises both active TIR-C and a matching placebo, providing the investigational product needed to initiate the company’s first study in patients.
STOCKHOLM, SWEDEN, September 24, 2026 – The clinical trial material was produced under Good Manufacturing Practice (GMP) by Zelmic, the contract development and manufacturing organisation responsible for the formulation development and manufacture of TIR-C. Release of the material follows completion of the associated manufacturing, analytical and quality-control activities and confirms that the investigational product meets the specifications required for administration to patients.
The release of the clinical trial material marks a key operational milestone ahead of the first-in-human Phase Ib study, in which TIR-C will be evaluated in patients with atopic dermatitis.
As previously announced, Pharmability received authorisation from the Swedish Medical Products Agency (Läkemedelsverket) this summer to initiate the trial.
The randomised, double-blind, placebo-controlled Phase Ib study will evaluate the safety and local tolerability of cutaneously administered TIR-C in adults with atopic dermatitis. Secondary objectives include the characterisation of systemic exposure (pharmacokinetics), while exploratory endpoints are intended to provide an initial assessment of efficacy.
“The GMP release of TIR-C and placebo is an important operational milestone and means that the investigational product is now ready for use in our Phase Ib study,” says Leo Holmgren, CEO of Pharmability. “With regulatory authorisation and clinical trial material in place, we are moving closer to enrolling and treating the first patients.”
For more information, please contact:
Leo Holmgren, CEO
Phone: +46 70 049 18 42
Email: leo.holmgren@pharmability.com
About Pharmability
Pharmability (formerly TIRmed Pharma) is a biotechnology company developing next-generation immunomodulatory therapies for autoimmune skin diseases, with an initial focus on atopic dermatitis (eczema). The company’s drug candidate, TIR-C, is a cutaneous oligonucleotide-based treatment that regulates immune responses and targets the disease’s underlying mechanisms. Promising preclinical results support its potential to provide long-lasting relief while reducing treatment burden. Building on expertise in immunology and drug development, the company is pioneering new solutions in dermatological immunotherapy to enable more targeted and effective treatment options.
Pharmability is headquartered in Stockholm, Sweden. For more information, visit pharmability.com and follow Pharmability on LinkedIn.
About Zelmic
Zelmic AB is a specialist CRO and CDMO focused on topical and transdermal drug development. Based in Lund, Sweden, the company offers end-to-end services from formulation and analytical development to IVRT/IVPT testing and GMP manufacturing of clinical materials. With deep expertise in semisolid formulations and regulatory compliance, Zelmic helps pharmaceutical and biotechnology partners turn topical drug concepts into effective, market-ready products. For more information, visit zelmic.se.
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