Andros announced on the 9th that its new drug, APC101, designed to alleviate postherpetic neuralgia (PHN) in the head and neck, has received approval from the Taiwan Food and Drug Administration (TFDA) to conduct a phase II clinical trial to evaluate its safety and efficacy.
This is a randomized, double-blind, placebo-controlled phase II clinical trial, expected to enroll 21 patients. The trial will assess the change in pain scores relative to baseline using the Numeric Rating Scale (NRS-11) after using APC101 twice daily, exploring its effectiveness and safety in patients with postherpetic neuralgia in the head and neck.
Andros stated that APC101, intended for the relief of postherpetic neuralgia, has completed a phase II preclinical trial in Australia. Notably, while the overall clinical results were excellent, the improvement in pain among patients with postherpetic neuralgia in the head and neck was particularly significant in the trial drug group. However, due to the small sample size, the significance of the indicators was limited.
Given the lack of available treatments for postherpetic neuralgia in the head and neck, the company has decided to conduct new clinical trials for this patient population. With TFDA approval for the phase II trial, recruitment will commence concurrently at Tri-Service General Hospital and Kaohsiung Medical University Hospital, with a total of 21 patients expected to be enrolled. Following the completion of the phase II clinical trial, the company will expedite the application for expedited review, aiming for early market approval to meet the urgent medical needs.
Chairman Ai-Jun Wang pointed out that the global market size for postherpetic neuralgia (PHN) in 2022 was $1.631 billion and is estimated to reach $2.122 billion by 2029, with an average annual compound growth rate of approximately 3.8%. However, due to the impact of the COVID-19 pandemic, there has been a 30% increase in confirmed cases of herpes zoster. After three months of diagnosis, persistent pain qualifies as postherpetic neuralgia. Therefore, it is estimated that the market size of PHN has further expanded after the pandemic.
Currently approved drugs for postherpetic neuralgia include oral medications such as Lyrica and Neurontin, as well as patch formulations like Lidoderm. However, oral medications can cause significant central nervous system toxicity and strong side effects, while patch medications are not easily applicable to the trigeminal nerve in the head and neck region. Andros's APC101, a local anesthetic spray, features a quick-drying film formula that allows rapid penetration into the skin and maintains it in the dermal layers, reducing systemic blood circulation toxicity without causing skin irritation. Moreover, as there are currently no marketed products available for local neuralgia in the head and neck, APC101 may have the opportunity to become the only topical product for neuralgia in this region.
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