Pharmability, a biotechnology company developing next-generation treatments for autoimmune skin diseases, today announced the completion of its GLP toxicology programme for TIR-C, the company’s drug candidate for atopic dermatitis (eczema). Positive results from complementary rat and minipig studies confirm a favourable preclinical safety profile, characterised by low systemic exposure and a clear safety margin, supporting the planned Phase Ib clinical trial.
The subcutaneous toxicity study in rats demonstrated a clear systemic safety margin. TIR-01, the active substance in TIR-C, was administered at exposures well above the intended clinical dose, with no mortality or test item-related clinical signs observed. The highest dose was established as the No Observed Adverse Effect Level (NOAEL) for systemic toxicity, and no notable accumulation was measured following repeated dosing. Expected local injection site reactions were observed at supraphysiological doses and were reversible.
In the minipig study, the clinical formulation TIR-C was well tolerated following repeated cutaneous administration. No adverse clinical findings were observed, and only negligible systemic exposure to TIR-01 was detected. These results indicate the absence of systemic toxicity at the intended route of administration, with good local tolerability even at the highest dose tested.
Taken together, the studies demonstrate that TIR-01 has a favourable systemic safety profile at exposures exceeding the intended clinical dose, and that TIR-C is well tolerated both locally and systemically when administered cutaneously. The findings represent an important step in Pharmability’s preclinical development and support the planned regulatory submission for its upcoming Phase Ib study.
“Completing the toxicology programme with these positive results is a major milestone for Pharmability,” says Leo Holmgren, CEO of Pharmability. “The data show that our drug candidate is well tolerated even at high exposure levels and, importantly, that systemic exposure is minimal following cutaneous administration. This strengthens the safety profile of cutaneous TIR-C treatment as we prepare for the Phase Ib study in atopic dermatitis.”
For more information, please contact:
Leo Holmgren, CEO
Phone: Tfn: +46 70 049 18 42
Email: [email protected]
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 topical 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.
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