TWi Biotechnology Initiates Phase 2a Clinical Trial of AC-1101 for Alopecia areata as AC-203 Approaches Key Readout Milestone

Taipei, June 1, 2026 — TWi Biotechnology, Inc. (6610-TW) today announced that it has submitted a Phase 2a clinical trial application to the Taiwan Food and Drug Administration (TFDA) for AC-1101, its investigational drug for the treatment of alopecia areata. As AC-203 approaches the topline readout of its global Phase 2/3 clinical trial expected in Q4 2026, TWi Biotechnology is also advancing AC-1101 into Phase 2a development for alopecia areata. This milestone expands the Company's pipeline beyond rare diseases and marks its entry into the dermatological immunology market. TWi Biotechnology stated that, as AC-203 enters a critical stage of development, AC-1101 further strengthens the value of the company's pipeline by expanding focus beyond rare diseases into dermatological immune disorders with broader market potential.

AC-1101 is a JAK inhibitor developed as a topical gel under the 505(b)(2) regulatory pathway. JAK inhibitors block specific immune signaling pathways, suppress inflammatory cellular responses, and reduce cytokine production. Compared with oral therapies, AC-1101 is applied topically to targeted skin areas to maximize localized efficacy. In addition to providing rapid onset of action, it may reduce the risk of systemic toxicity associated with oral treatments. In the treatment of alopecia areata, AC-1101 offers a localized approach that significantly reduces systemic drug exposure. This mitigates the adverse events associated with the systemic absorption of oral JAK inhibitors, positioning AC-1101 as a potentially safer, highly effective, and best-in-class alternative to current therapies.

Targeting a Multi-Billion-Dollar Global Market with a Differentiated Topical JAK Therapy

Alopecia areata is a common autoimmune disease in which the immune system attacks hair follicles, resulting in patchy or complete hair loss. The disease affects approximately 2% of the global population, with an estimated 60 to 100 million people experiencing the condition during their lifetime. It commonly occurs in adolescents and young adults and can have a significant impact on patients' appearance and social well-being.

Recent regulatory approvals and commercial launches of oral JAK inhibitors have propelled rapid growth in the alopecia areata market, making it a highly watched sector in dermatological immunology. However, systemic exposure of oral JAK inhibitors may still be associated with risks such as infections, immunosuppression, and thrombotic events, which may limit their adoption among patients and physicians.

TWi Biotechnology believes that topical JAK inhibitors, such as AC-1101, offering both efficacy and safety may represent an important future direction for the market.

AC-1101 Developed Through the 505(b)(2) Pathway with Potential to Become a Best-in-Class Product

AC-1101 is a JAK inhibitor developed as a topical gel under the 505(b)(2) regulatory pathway. By leveraging existing safety and efficacy data of the active ingredient, the Company expects to reduce development risk, shorten development timelines, and improve capital efficiency.

Compared with oral therapies for alopecia areata, AC-1101 may significantly reduce systemic drug exposure while minimizing the risk of treatment-related side effects. As a result, AC-1101 has the potential to become a best-in-class therapy with a favorable efficacy and safety profile.

Phase 2a Trial Expected to Begin in the Third Quarter; Preliminary Data May Be Available in the Second Quarter of Next Year

The Phase 2a clinical trial will adopt an open-label design and focus on patients with mild-to-moderate alopecia areata. In addition to evaluating safety, the study will utilize the internationally recognized Severity of Alopecia Tool (SALT) to assess changes in disease severity and hair regrowth before and after treatment.

Subject to TFDA approval, patient enrollment will be conducted at National Taiwan University Hospital, Taipei Medical University Hospital, and Shuang Ho Hospital. The study is expected to begin as early as the third quarter of 2026, and preliminary data may be available in 2027 if enrollment proceeds as planned.

AC-203 Approaches Fourth-Quarter Readout, Continuing to Enhance Portfolio Value

Dr. Chen-En Tsai, President and Chief Medical Officer of TWi Biotechnology, stated:

  "2026 will be a highly significant year for TWi Biotechnology. In addition to the upcoming global pivotal trial readout for AC-203 expected in Q4 2026, AC-1101 has now formally entered clinical development for alopecia areata, reflecting our continued progress in advancing our pipeline and expanding future growth opportunities."

Dr. Tsai added:

 “We believe that AC-203 and AC-1101 address two strategically important markets that will serve as key drivers of the Company's future growth. TWi Biotechnology remains committed to expanding its presence in dermatological diseases while evaluating global licensing and strategic partnership opportunities at the appropriate time to accelerate worldwide commercialization."

Building a Dermatology Franchise for the Next Phase of Growth

TWi Biotechnology's other core development candidate, AC-203, is being evaluated for Epidermolysis Bullosa Simplex (EBS), a rare disease for which there are currently no approved treatments. The global phase 2/3 study is being conducted across 19 countries, with topline efficacy results expected in Q4 2026.

If the study is successful, the Company plans to begin preparations for pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and pre-Submission meeting with the European Medicines Agency (EMA), followed by regulatory submissions and global commercialization activities.