Pipeline

Izokibep is a unique antibody mimetic and potent
interleukin-17A (IL-17A) inhibitor designed to overcome the limitations of existing monoclonal antibodies.

INDICATION
PRECLINICAL
PHASE 1
PHASE 2
PHASE 3

* FDA has previously granted orphan drug status for the treatment of these rare diseases.

Indications

We are actively investigating the potential of izokibep in diseases where differentiated inhibition of interleukin-17A signaling may help to address unmet patient needs.

Uveitis:

Uveitis is an inflammatory disease that produces swelling and loss of vision through the destruction of eye tissues. There is a significant need for improved treatment options as uveitis causes about 30,000 new cases of blindness each year in the United States alone.

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Axial Spondyloarthritis:

Axial spondyloarthritis (AxSpA) is an inflammatory musculoskeletal disease that mainly affects the spine, the pelvic joints, and the sites where ligaments and tendons attach to bones called “entheses”. It is estimated as many as 2.7 million adults in the United States have axial spondyloarthritis.

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Hidradenitis Suppurativa:

Hidradenitis suppurativa (HS) is a very painful, lifelong, and recurring skin condition that causes abscesses and scarring. Areas often affected include the groin and genitals, the armpits, areas around the anus, and below the breasts. The exact cause of hidradenitis suppurativa is unknown although it is thought to affect 0.1%-2% of the population.

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Psoriatic Arthritis:

Psoriatic arthritis (PsA) is a chronic, inflammatory disease that affects the joints, skin, nails, spine and sites where ligaments and tendons attach to bones called “entheses”. It is estimated that about 30% of psoriasis patients will develop psoriatic arthritis.

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About Enthesitis:

Entheseal tissues anchor muscles to bone and bones to bone through tendons and ligaments. Given this role, enthesites have very high strength, are very dense tissues, and are poorly vascular, making penetration by large molecules like monoclonal antibodies difficult. It is estimated that 50-60% of patients with PsA experience enthesitis, which presents more frequently in more serious patients and is associated with increased disease activity, reduced quality of life and worse prognostic outcomes. Currently approved therapies demonstrate enthesitis resolution in approximately only 45-60% of patients.

IZOKIBEP

To date, more than 300 patients – many for up to three years – have received izokibep, a unique, antibody mimetic, interleukin-17A (IL-17A) inhibitor designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size, izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies require IV administration to achieve. Additionally, the small size of izokibep – about a tenth the size of a monoclonal antibody – also enables its potential to reach targeted tissues that may otherwise be inaccessible to the much larger monoclonal antibodies.

ABOUT IL-17

IL-17A is one of the best-studied cytokines in immunology, especially around its involvement in inflammatory pathology. IL17 has a major role in numerous inflammatory diseases and inhibiting IL-17A signaling has proven effective in treating a variety of diseases including plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. IL-17 plays a role in other rare diseases and conditions including non-infectious uveitis, an inflammation inside the eye, and hidradenitis suppurativa, a devastating, chronic inflammatory disease of the exocrine glands characterized by painful malodorous lumps under the skin that can become scarred and disfiguring.

IMPACT

With its unique properties, including extraordinary potency and small molecular size, izokibep can overcome the limitations of existing monoclonal antibodies and achieve high drug exposures and enhanced tissue penetration. In addition, because of the extremely high potency and much reduced molecular size, izokibep can reach high drug exposure levels through a single subcutaneous injection that monoclonal antibodies require intravenous (IV) administration to achieve. Therefore, izokibep has the potential to offer meaningfully differentiated efficacy in a host of IL-17 autoimmune diseases positively impacting the lives of patients around the world.

Izokibep is not yet approved for use in any indication.