Chinese biotech company Asieris Pharmaceuticals has completed enrolment for its Phase Ib trial in the US to evaluate the safety, tolerability, and PK characteristics of APL-1202.
APL-1202 is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor and is currently being developed to treat non-muscle invasive bladder cancer (NMIBC), one of the most common malignant tumours.
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The drug has novel mechanisms of action of inhibiting tumour cell growth as well as angiogenesis.
The Phase Ib clinical trial will evaluate APL-1202 in combination with intravesical BCG in NMIBC patients who have received at least one induction course of intravesical BCG.
Patient follow-up is expected to be completed in September this year.
Asieris plans to launch a Phase II global clinical trial to evaluate the efficacy and safety of a combination of the drug with BCG in patients with NMIBC.
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By GlobalDataAsieris co-founder, chairman and CEO Kevin Pan said: “The completion of enrolment for our APL-1202 Phase Ib clinical trial in the US represents a remarkable milestone for APL-1202’s global clinical development.
“Intravesical BCG is the first-line therapy for NMIBC globally, and through the clinical trials of APL-1202 in combination with intravesical BCG, we hope to provide a better treatment for NMIBC patients in the world.”
The common treatment of NMIBC at present is Trans-Urethral Resection of Bladder Tumour (TURBT).
Asieris develops and commercialises new drugs for the treatment of genitourinary tumours and related diseases.
