ACELYRIN, INC. to Accelerate Development of Izokibep in Hidradenitis Suppurativa

• Izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR) in open label Part A of a Phase 2b/3 trial 
• Safety results consistent with previous trials of izokibep as well as the IL-17Ai class as a whole, with no increased risk of infection, including candida
• Based on these results, ACELYRIN is prioritizing development of HS by accelerating initiation of the second confirmatory trial

LOS ANGELES, Jan. 5, 2023 /PRNewswire/ -- ACELYRIN, INC., a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced top-line 12-week open label data from Part A of a Phase 2b/3 trial of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS). HS is an autoimmune disease characterized by inflammation of the exocrine glands and leading to skin abscesses, pain, scarring, malodor and a devastating impact on patient's quality of life. The double-blind, placebo-controlled Part B of this Phase 2b/3 trial is ongoing and based on the Part A results, ACELYRIN will accelerate initiation of the second confirmatory trial in HS.

The 30-patient open label Part A of the Phase 2b/3 trial evaluated clinical response and safety of izokibep administered to patients with moderate-to-severe HS via subcutaneous injection. Izokibep demonstrated higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR), where low-to-no placebo responses have been reported historically. The safety data reported were consistent with previous trials of izokibep as well as the IL-17Ai class as a whole. Notably, there was no evidence of increased risk of infection and no candida infections were reported in this trial.

"We are thrilled to be seeing these higher orders of HiSCR response and a safety profile consistent with previous trials of izokibep and no increase of infection, including candida, " said Shao-Lee Lin, MD, PhD, founder and CEO of ACELYRIN. "In addition to the data previously presented in psoriatic arthritis, these results in a second disease indication further support the hypothesis that the high potency and small size of izokibep could lead to clinically meaningful and differentiated impact in multiple diseases, especially those with difficult to treat tissues. Based on these data, we are pleased to prioritize development of izokibep in HS, potentially accelerating its availability to patients."

The full data from Part A of this trial will be presented at a future scientific meeting.

Izokibep has been administered to over 300 patients, some for up to three years. It is a small therapeutic protein inhibitor of interleukin-17A (IL-17A) designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size – about one tenth the size of a traditional monoclonal antibody – izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies otherwise require IV administration to achieve. We have hypothesized that these characteristics could lead to clinically meaningful and differentiated impact in multiple diseases.

ACELYRIN, INC. is a Los Angeles area-based late-stage clinical biopharmaceutical company – with additional operations in the San Francisco Bay area – focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating development and commercialization of promising drug candidates. For more information, please visit www.acelyrin.com.

This press release may contain forward-looking statements, including statements regarding the ability to offer treatments with clinically meaningful, differentiated benefits, the safety and tolerability profile of izokibep, the ability to accelerate development of izokibep in HS, the ability to complete a second confirmatory trial of izokibep in HS, the potential for izokibep to be better than intravenous monoclonal antibodies, and the ability to execute on the goal of acquiring and accelerating development of product candidates. While ACELYRIN, INC. considers any projections to be based on reasonable assumptions, these forward-looking statements may be called into question by numerous hazards and uncertainties, and actual results may differ materially from those anticipated in such forward-looking statements.

SOURCE ACELYRIN, INC.