Greywolf Therapeutics begins dosing of the first treatment to target the antigenic source of autoimmunity

• This is the first-ever autoimmunity study to evaluate a potential functional cure that targets the antigenic source – the origin of autoimmune disease
• The Phase 1/2 study (up to 141 participants) will evaluate the safety, tolerability and efficacy of GRWD0715 in healthy volunteers and participants with axial spondyloarthritis (axSpA)
• GRWD0715 is an investigational small molecule designed to interrupt T-cell activation by inhibiting the peptide processing enzyme ERAP1 (Endoplasmic Reticulum Aminopeptidase 1)
• AxSpA has no cure and affects an estimated 0.5–1.4% of the global population - millions worldwide - leading to chronic inflammatory back pain, spinal stiffness, and significant disability if untreated

Greywolf Therapeutics, the clinical-stage biotech company advancing novel antigen modulation technology to guide the immune system, have successfully dosed the first healthy volunteer in their Phase 1/2 trial (NCT07047703) evaluating GRWD0715, an oral ERAP1 inhibitor, for the treatment of axial spondyloarthritis (axSpA).

Tom Lillie, Chief Medical Officer at Greywolf Therapeutics:

The strong genetic association between ERAP1 and axSpA make it a very compelling primary indication for our first autoimmunity trial, and we’re excited by the impact we could deliver to this underserved community. Whilst current therapies seek to suppress various inflammatory mediators produced by activated T cells, we’re taking a distinctly different approach with our program and aim to target the source of disease by interrupting autoantigen presentation, preventing the damaging T-cell response from continuing.

In people living with axSpA, the immune system mistakenly recognises the body’s own proteins as foreign and attacks healthy tissue, particularly in the spine and sacroiliac joints. In vitro models have shown that GRWD0715 modulates cell-surface antigens, removing the target antigen incorrectly recognised in axSpA patients and preventing T cells from attacking healthy tissue.

The Phase 1 component of the study will evaluate the safety and tolerability of GRWD0715 in healthy volunteers (up to 24 participants) and people living with axSpA (up to 36 participants). Findings from this part of the study will be used alongside proof-of-mechanism data to identify the biologically active dose for progression into the Phase 2 arm of the trial.

Peter Joyce, CEO and Co-founder of Greywolf Therapeutics:

We believe GRWD0715 represents a turning point in the treatment paradigm for autoimmune diseases like axSpA, offering the possibility of a functional cure by targeting the disease at its antigenic source. Dosing the first participant in this trial marks a major milestone for the company, testing the power of our antigen modulation approach to treat axSpA and bringing us closer to our goal of addressing significant unmet need in autoimmune diseases.