Hanlim Pharm said it would test HL301, a drug candidate for bronchitis, to check if it can treat radiation pneumonitis. The move is to obtain the medicine’s additional indication for radiation pneumonitis, observers said.
The Ministry of Food and Drug Safety on Friday granted the nod to Hanlim Pharm to go ahead with the phase-2a trial on HL301.
The study will be on 87 patients with primary lung cancer who did not undergo surgical treatment but need a treatment of radiation pneumonitis.
The trial will evaluate HL301’s efficacy and safety for radiation pneumonitis by comparing the group with HL301 administration and the placebo group. It will be a multi-center, randomized, double-blind, and placebo-controlled study.
Hanlim Pharm is developing HL301 as a treatment for acute bronchitis. The drugmaker inked a deal with GMP (formerly Good Medi) to use the patent on “Preventing Chronic Obstructive Pulmonary Disease” to develop the experimental drug.
In January 2017, Hanlim obtained approval for a phase-2 trial to compare efficacy and safety between HL301-administered group and the placebo group in patients with acute bronchitis.
In February 2018, the company received the green light for a phase-3 study to compare the efficacy and safety of HL301 and Umckamin in patients with acute bronchitis.
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