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Therapeutic Focus

We are exploring innovative approaches in immunology where we have the opportunity to make a clinically meaningful difference for patients relative to standard of care.
Therapeutic Focus
Program
indication
preclinical
phase 1
phase 2
phase 3
rights
Izokibep
(anti-IL-17A)
Hidradenitis Suppurativa 1
Psoriatic Arthritis 2
Global 3
Axial Spondyloarthritis 4
Uveitis 1
Lonigutamab (anti-IGF-1R)
Thyroid Eye Disease
Global 5
SLRN-517
(anti-C-KIT)
Chronic Urticaria 6
Global

1 Phase 2b/3 trial in moderate to-severe hidradenitis suppurativa (HS) and uveitis. Planned inclusion into registrational package for HS and non-infectious uveitis (as applicable) if granted orphan drug designation and following consultation with relevant heath authorities. We have not previously completed any clinical trials for uveitis and have initiated our first Phase 2b/3 trial.

2 Phase 2b/3 trial in PsA.

3 Excludes development, commercialization and manufacturing rights in mainland China, Hong Kong, Macau, South Korea and Taiwan, and development rights in certain other Asia Pacific countries. We retain decision making authority for izokibep global development.

4 Based on data from our Phase 2 and ongoing Phase 2b/3 trials in PsA, we intend to discuss with the FDA initiation of the Phase 3 program in AxSpA without completing earlier clinical trials in AxSpA. The FDA may require us to complete a Phase 2 trial in AxSpA prior to initiating our planned Phase 3 program.

5 Worldwide rights to non-oncology indications.

6 Based on preclinical studies demonstrating highly potent inhibition of the c-KIT pathway targeting mast cell proliferation and degranulation, our first indication of interest for SLRN-517 is chronic urticaria, an inflammatory disease that is driven by the release of histamine and other vasoactive molecules produced by mast cells.

Indications

Hidradenitis Suppurativa

Psoriatic Arthritis

Axial Spondyloarthritis

Uveitis

Thyroid Eye Disease

Chronic Urticaria

Hidradenitis suppurativa (HS) is a very painful, lifelong, and recurring skin condition that causes abscesses and scarring 1,2. Areas often affected include the groin and genitals, the armpits, areas around the anus, and below the breasts1,2.

*Izokibep is not yet approved for use in any indication.

Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a very painful, lifelong, and recurring skin condition that causes abscesses and scarring1,2. Areas often affected include the groin and genitals, the armpits, areas around the anus, and below the breasts1,2. The exact cause of hidradenitis suppurativa is unknown although it is thought to affect 0.1%-2% of the population1,2,3. Treatments can include antibiotics, steroids, immunosuppressants, and in moderate to severe cases, drainage, and removal of the abscesses with surgery. There is no cure, and the condition requires constant management3. Current therapies provide ~50% improvement in ~50% of patients4. Recurrent disease (disease flares) and painful lesions remain additional unmet needs. IL-17 has been found to be elevated in HS lesions and an increase in IL-17A gene expression was observed in HS skin, suggesting that IL-17 inhibition could be an effective therapeutic target2. IL-17 inhibition may address unmet needs by providing better disease control as well as lessening disease flares and reducing pain. Given the elevated risk of skin and non-skin infections for HS patients, the safety profile of potential therapies, especially around increased risk of infections, must also be considered.5 The unique qualities of izokibep and the known safety profile of IL-17A inhibition makes izokibep an ideal candidate to test in the clinic to potentially benefit patients with HS.

  1. www.nhs.uk/conditions/hidradenitis-suppurativa/
  2. Clin Exp Immunol. 201(2), 121–134 (2020)
  3. J Am Acad Dermatol. 81(1), 91-101 (2019)
  4. N Engl J Med. 375, 422-434 (2016)
  5. Br J Dermatol. 182, 327-334 (2020)
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