Arvin Pharmaceuticals Announces Completion of Patient Enrollment in U.S. Phase Ib Clinical Trial of APL-1202 for Non-Muscle Invasive Bladder Cancer

VCBeat (WeChat ID: biobeat1) has learned that Asieris, a global innovative drug R&D company focused on anti-tumor and related diseases of the urogenital system, announced today that patient enrollment for its Phase Ib clinical trial of APL-1202 in the United States has been completed.

This novel drug, the first oral and reversible methionine aminopeptidase 2 (MetAP2) inhibitor to enter clinical studies worldwide, is indicated for the treatment of non-muscle-invasive bladder cancer. MetAP2 inhibitors suppress both tumor cell growth and tumor angiogenesis. Currently, APL-1202 has entered the registration-enabling clinical trial phase in China.

The primary objective of this U.S. Phase Ib clinical trial was to evaluate the safety, tolerability, and pharmacokinetic profile of APL-1202 in combination with intravesical Bacillus Calmette-Guérin (BCG) therapy. Enrolled patients had non-muscle-invasive bladder cancer (NMIBC) and had previously received at least one course of BCG induction therapy. Patient follow-up for this clinical trial is expected to be completed by September. Asieris Pharmaceuticals is currently preparing to initiate a global Phase II clinical trial to assess the efficacy and safety of oral APL-1202 combined with intravesical BCG instillation in patients with NMIBC.

“We are pleased to have participated in the Phase Ib clinical trial evaluating the combination of APL-1202 and bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder cancer (NMIBC) who have previously received BCG therapy and exhibit BCG resistance. This trial holds significant potential to improve treatment outcomes for patients with NMIBC. The availability of an oral medication represents a highly exciting therapeutic option for our patients,” commented Dr. John P. Sfakianos, Assistant Professor at the Icahn School of Medicine at Mount Sinai and principal investigator of this clinical study. “I eagerly look forward to further research on this treatment approach.”

“The successful completion of enrollment in the U.S. Phase Ib clinical trial of APL-1202 marks a significant milestone in its international clinical development. In a Phase II clinical trial in China, APL-1202 demonstrated encouraging efficacy and safety as a monotherapy for non-muscle-invasive bladder cancer (NMIBC). A pivotal clinical trial evaluating APL-1202 in combination with intravesical chemotherapy is currently underway in China. Bacillus Calmette-Guérin (BCG) intravesical instillation remains the first-line treatment for NMIBC globally. Through international clinical studies combining APL-1202 with BCG, we aim to provide improved therapeutic options for patients worldwide at an earlier date,” said Dr. Ke Pan, Co-founder, Chairman, and CEO of Asieris Pharmaceuticals.

Bladder cancer is highly prevalent worldwide. According to GLOBOCAN, there were 549,343 new cases and 199,922 deaths from bladder cancer globally in 2018. The disease predominantly affects males and is more common in developed countries. The current standard treatment is transurethral resection of bladder tumor (TURBT). Due to the high rate of postoperative recurrence, intravesical instillation of Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy is required. Currently, second-line treatment options for recurrent cases are very limited, and the standard therapy for high-risk patients who fail intravesical instillation is radical cystectomy. No oral medications have been approved for marketing to date.

Asieris Pharmaceuticals was established in March 2010 in China Medical City, Taizhou, Jiangsu Province, and has set up a research and development center in Shanghai. It is the only domestic global innovative drug R&D company focused on anti-tumor and related diseases of the urogenital system. Asieris Pharmaceuticals is committed to becoming the most innovative, influential, respected, and trusted pharmaceutical enterprise in its specialized field.

The company focuses on the urogenital field and has rapidly established a leading position in this area while implementing in-depth strategic layouts. By adopting a dual-engine drive model of "independent R&D" and "external introduction," it fully explores the global value of first-in-class new drugs with breakthrough therapeutic potential developed independently, while also introducing new drugs that are in late-stage development or already marketed overseas into the Chinese market. This enhances the diversity and synergy of its product pipeline, quickly establishing a leading position in the domestic market.