Luye Pharma Group announced that it has started the enrollment of subjects for phase I clinical trials in China of its in-house investigational drug LY03014, a Class 1 new chemical compound. LY03014 is indicated for the treatment of moderate to severe postoperative pain and breakthrough cancer pain (BTcP).
The first phase I clinical trial of LY03014 is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial in healthy Chinese subjects, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of a single intravenous infusion of LY03014 in humans.
More than 300 million patients undergo surgery worldwide each year. Among these patients, over 80% experience postoperative pain, and about 75% experience acute postoperative pain. Opioids are the most common medication for moderate to severe pain and the critical drug for postoperative pain medication. There is no risk of addiction on condition that the postoperative pain medication does not exceed 72 hours generally.
However, lethal respiratory depression is the most significant risk factor when using currently available opioids in the management of postoperative pain and BTcP. Furthermore, respiratory depression is also a major cause of death following the use of opioids, and therefore all opioids on the market must include this black box warning.
In contrast to conventional opioids, LY03014 is a novel small molecule Gi protein biased at μ-opioid receptor agonist, which is designed to reduce the incidence of opioid-related adverse events, such as respiratory depression and gastrointestinal dysfunction, while providing analgesic effects. Non-clinical pharmacodynamic and pharmacokinetic studies have shown that the product significantly reduces pain and reduces the incidence of respiratory depression, constipation, and opioid tolerance. In addition, according to completed toxicology studies and the cardiovascular safety observed in long-term telemetry monitoring, LY03014 has not caused liver toxicity and changes in cardiac QT interval (an important parameter of cardiac safety).
According to data from IQVIA, the value of China’s analgesics market reached RMB 15.82 billion in 2019, with a compound annual growth rate (CAGR) of 17.4% from 2017 to 2019. Luye Pharma believes that analgesic drugs have favorable market prospects and growth potential, both in China and in other major pharmaceutical markets. LY03014 will enrich the company’s portfolio in the area of analgesics and bolster the company’s development in this field of treatment.
Luye Pharma already has several analgesic products on the global market, such as Buprenorphine transdermal patches and Fentanyl transdermal patches. In addition to these, the company also has multiple new drugs currently under research and development, including the innovative small molecule pain relief oral drug LY03012.
Luye Pharma Group announced that it has started the enrollment of subjects for phase I clinical trials in China of its in-house investigational drug LY03014, a Class 1 new chemical compound. LY03014 is indicated for the treatment of moderate to severe postoperative pain and breakthrough cancer pain (BTcP).
The first phase I clinical trial of LY03014 is a randomized, double-blind, placebo-controlled, dose-escalation clinical trial in healthy Chinese subjects, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic characteristics of a single intravenous infusion of LY03014 in humans.
More than 300 million patients undergo surgery worldwide each year. Among these patients, over 80% experience postoperative pain, and about 75% experience acute postoperative pain. Opioids are the most common medication for moderate to severe pain and the critical drug for postoperative pain medication. There is no risk of addiction on condition that the postoperative pain medication does not exceed 72 hours generally.
However, lethal respiratory depression is the most significant risk factor when using currently available opioids in the management of postoperative pain and BTcP. Furthermore, respiratory depression is also a major cause of death following the use of opioids, and therefore all opioids on the market must include this black box warning.
In contrast to conventional opioids, LY03014 is a novel small molecule Gi protein biased at μ-opioid receptor agonist, which is designed to reduce the incidence of opioid-related adverse events, such as respiratory depression and gastrointestinal dysfunction, while providing analgesic effects. Non-clinical pharmacodynamic and pharmacokinetic studies have shown that the product significantly reduces pain and reduces the incidence of respiratory depression, constipation, and opioid tolerance. In addition, according to completed toxicology studies and the cardiovascular safety observed in long-term telemetry monitoring, LY03014 has not caused liver toxicity and changes in cardiac QT interval (an important parameter of cardiac safety).
According to data from IQVIA, the value of China’s analgesics market reached RMB 15.82 billion in 2019, with a compound annual growth rate (CAGR) of 17.4% from 2017 to 2019. Luye Pharma believes that analgesic drugs have favorable market prospects and growth potential, both in China and in other major pharmaceutical markets. LY03014 will enrich the company’s portfolio in the area of analgesics and bolster the company’s development in this field of treatment.
Luye Pharma already has several analgesic products on the global market, such as Buprenorphine transdermal patches and Fentanyl transdermal patches. In addition to these, the company also has multiple new drugs currently under research and development, including the innovative small molecule pain relief oral drug LY03012.
