SHANGHAI--(BUSINESS WIRE)--Dec 31, 2024--
Xgene Pharmaceutical announced additional insights into the positive results of a multiple-center, placebo-controlled, dose-ranging Phase 2b study (registration number: NCT06017999) in patients undergoing bunionectomy, evaluating the safety and efficacy of the XG005 oral tablet on acute pain.
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XG005 is a non-opioid, new chemical entity with dual mode of action in targeting both nociceptive and neuropathic pain signals. The placebo, 750 mg or 1250 mg of XG005, was administered orally twice a day (bid) for 72 hours to patients undergoing bunionectomy. The study was collaborated with Evolution Research Group and Lotus Clinical Research at multiple sites in the USA. A total of 450 subjects were enrolled into the trial with 1:1:1 randomization ratio. The drug was well tolerated with an acceptable safety profile. There were no drug-related serious adverse events.
The primary and the key secondary efficacy endpoints of SPI over 48 hours for the 1250 mg and 750 mg dose group versus placebo achieved statistically significant difference, respectively with 1250 mg dose providing significantly more analgesia than 750 mg.
Other efficacy endpoints are briefly listed below:
“I have not seen any analgesics showing such great efficacy in well-controlled multiple center trials. Mean pain severity was mild at the most in high dose group versus severe in placebo group. The amount of rescue medication used, including opioids, was less than 1/3 in the high dose arm compared with placebo. The standard effect sizes for the primary (high dose) and the key secondary (low dose) efficacy endpoints are 1.55 and 1.28, respectively. This compelling efficacy of XG005 overwhelmingly distinguishes it from other analgesics and we are extremely encouraged to expedite the development for early delivery to patients.” said Leon Jiang, Chief Medical Officer at Xgene Pharmaceutical.
“There is a substantial need for more efficacious, safer, non-opioid treatment for acute pain, as many patients are unable to get sufficient relief with currently available medicines due to intolerable side effects. We are pleased that the results from this trial showed the excellent therapeutic effect of XG005, with the potential to be a better treatment option compared to current therapies,” said Gene Hsu, CEO of Xgene. “Xgene is proud to continue its efforts on this unique product, moving forward with great confidence.”
About Acute Pain
Acute pain is defined as pain lasting less than 3 months. In 2023, the acute pain market was valued at approximately USD 50.03 billion and project to reach around USD 78.36 billion by 2032. Due to limited non-opioid treatment options, there is an unmet need in acute pain management to improve the patient experience and reduce the economic and societal burden. ( Acute Pain Market Size, Share, Trends & Report | 2032 )
About XG005
XG005 is a novel molecule targeting two distinct pain pathways: an anti-nociceptive and an anti-neuropathic. It is potentially first-in-class oral treatment that is in parallel development for treatment of acute and chronic pain conditions. Due to its dual mechanism of action, XG005 is potentially able to provide greater inhibition of the pain signal transmission achieving better analgesic outcomes while providing good safety profile.
A positive phase 2b trial results of XG005 treatment in chronic osteoarthritis pain was recently reported, and a Phase 2 trial of XG005 in cancer-induced bone pain is currently ongoing in Taiwan and Mainland of China.
About Xgene Pharmaceutical: Transforming Medicine for Better Lives
At Xgene, we apply new clinical findings, science, and innovative technology to bring therapies to patients to extend and significantly improve their lives. We strive for quality, safety and value in our new products. Our goal is to deliver the world's best medicine to patients worldwide. Xgene’s drug discovery areas include pain and CNS conditions focusing research on finding treatments and cures for unmet medical needs. We collaborate with health care providers, governments, and local communities to identify patient needs and deliver reliable, affordable medicines around the world. Visit our website at www.xgenepharm.com.
Pain Intensity Score (Graphic: Business Wire)
The top diplomats from Germany and France were in Syria on Friday to send what the German minister called a clear signal that a “political new beginning" between Europe and Syria is possible after the ouster of Bashar Assad.
German Foreign Minister Annalena Baerbock and her French counterpart, Jean-Noël Barrot, were expected to meet the leader of the group that toppled Assad, Ahmad al-Sharaa, and representatives of Syrian civil society.
Baerbock said there can be a “new beginning” only if the new Syrian society gives all people, regardless of ethnic or religious group, “a place in the political process” as well as rights and protection.
Israeli airstrikes on Thursday and Friday killed at least 50 people in Gaza, including an attack on a sprawling tent camp that Israel has repeatedly bombed despite designating it a humanitarian safe zone. Israel said that the strike targeted a high-ranking police officer, and blames Hamas for civilian deaths.
The Israel-Hamas war in Gaza has killed more than 45,500 Palestinians, according to local health officials, who say women and children make up more than half the fatalities. The officials don't distinguish between civilians and combatants in their tally.
The war was sparked by Hamas-led militants' attack in Israel on Oct. 7, 2023. They killed about 1,200 people, mostly civilians, and abducted around 250 that day. Around 100 hostages are still inside Gaza, at least a third believed to be dead.
Here's the latest:
BEIRUT — Lebanon's army said Friday that a clash occurred along the Lebanese-Syrian border in the east when Syrians attempted to reopen an illegal border crossing using a bulldozer.
Lebanese army personnel fired warning shots, prompting the Syrians to open fire, wounding one soldier. Following the incident, army units in the area implemented strict security measures, and the incident is under investigation, the Lebanese army said.
Meanwhile, Syria’s de facto leadership under the group Hayat Tahrir al-Sham announced new entry regulations for Lebanese citizens. Lebanese travelers must secure a residence permit or a Syrian sponsor and provide proof of funds worth $2,000 and a hotel booking. Previously, Lebanese citizens were allowed to enter with just a Lebanese ID card.
DAMASCUS — French Foreign Minister Jean-Noël Barrot visited the long-shuttered French Embassy in Damascus on Friday as part of the first visit to Syria by top diplomats from European Union countries following the overthrow of President Bashar Assad by opposition rebels.
Barrot and German Foreign Minister Annalena Baerbock are expected to meet with Ahmad al-Sharaa, formerly known as Abu Mohammed al-Golani, the leader of Hayat Tahrir al-Sham, the Islamist former insurgent group that is now the de facto ruling party in Syria.
“It was with great emotion that I am today at the site of the French Embassy in Damascus,” Barrot said as he inspected the damage that occurred at the embassy during 13 years of closure.
“A little less than a month ago, new hope was born thanks to the mobilization of Syrians, the hope of a sovereign, stable and peaceful Syria,” he said. "It is a real hope, but it is a fragile hope.”
Barrot earlier visited the Christian neighborhood of Bab Touma and met with Patriarch John Yaziji.
DEIR AL-BALAH, Gaza Strip — At least 30 people, including children, were killed in Gaza by strikes overnight, hospital staff said Friday.
Staff at the Al Aqsa Martyrs hospital said that 10 women and seven children were among those killed in strikes on various locations in Central Gaza, including Nuseirat, Zawaida, Maghazi and Deir al Balah.
The strikes come a day after dozens of people were killed across the enclave, bringing the total of fatalities since Thursday to 56.
The strikes on Thursday hit Hamas security officers and an Israeli-declared humanitarian zone.
The Israeli army, which didn't immediately comment on the strikes, says it only targets militants and blames Hamas for civilian deaths.
JERUSALEM — The Israeli military says a missile fired from Yemen has set off air raid sirens in Jerusalem and central Israel.
The attack early Friday woke millions of people and sent people scrambling to air raid shelters.
There were no immediate reports of injuries or damage, though a faint explosion, likely either from the missile or from interceptors, could be heard in Jerusalem.
The Israeli Defense Forces later reported that a missile launched from Yemen into Israeli territory was intercepted. A report was received regarding shrapnel from the interception that fell in the area of Modi’in in central Israel. The details are under review.
Israel has carried out a number of long-range airstrikes in Yemen, about 2,000 kilometers (1,200 miles) away. But the strikes have failed to stop the attacks. The Houthis have pledged to continue striking Israel until the war in Gaza ends.
French Foreign Minister Jean-Noel Barrot meets with representatives of civil society during an official visit, in Damascus, Syria, Friday, Jan. 3, 2025. (AP Photo/Mosa'ab Elshamy)
People walk past a security building that belonged to the Assad regime which was burned during the rebel takeover, in Damascus, Syria, Friday, Jan. 3, 2025. (AP Photo/Mosa'ab Elshamy)
French Foreign Minister Jean-Noel Barrot meets with representatives of civil society during an official visit, in Damascus, Syria, Friday, Jan. 3, 2025. (AP Photo/Mosa'ab Elshamy)
French Foreign Minister Jean-Noel Barrot, center, meets with representatives of civil society during an official visit, in Damascus, Syria, Friday, Jan. 3, 2025. (AP Photo/Mosa'ab Elshamy)
French Foreign Minister Jean-Noel Barrot meets with representatives of civil society during an official visit, in Damascus, Syria, Friday, Jan. 3, 2025. (AP Photo/Mosa'ab Elshamy)
German and French Foreign Affairs ministers Annalena Baerbock, center right, and Jean-Noel Barrot, center left, talk with representatives of the White Helmets during a guided visit to the infamous Saydnaya military prison north of Damascus, Syria, Friday Jan. 3, 2023.(AP Photo/Omar Sanadiki).
German and French Foreign Affairs ministers Annalena Baerbock, center left,, and Jean-Noel Barrot, right, listen to representatives of the White Helmets during a guided visit to the infamous Saydnaya military prison north of Damascus, Syria, Friday Jan. 3, 2023.(AP Photo/Omar Sanadiki).
French Foreign Affairs Minister Jean-Noel Barrot talks with a representative of the White Helmets during a visit to the infamous Saydnaya military prison north of Damascus Friday Jan. 3, 2023. The Saydnaya prison, a sprawling complex just north of Damascus became synonymous with some of the worst atrocities committed under the rule of now ousted President Bashar Assad.(AP Photo/Omar Sanadiki).
Colleagues and friends mourn over the body of freelance journalist Omar al-Derawi and other victims of overnight Israeli army strikes at multiple locations in central Gaza Strip, at Al-Aqsa Martyrs Hospital in Deir al-Balah, Friday, Jan. 3, 2025. According to Al-Aqsa Martyrs Hospital, 30 people, including 10 women and 7 children, were killed in several attacks overnight in central Gaza. (AP Photo/Abdel Kareem Hana)
German and French Foreign Affairs ministers Annalena Baerbock, second from left, and Jean-Noel Barrot, second from right, talk with representatives of the White Helmets during a guided visit to the infamous Saydnaya military prison north of Damascus, Syria, Friday Jan. 3, 2023.(AP Photo/Omar Sanadiki).
A wounded man is brought to Al-Aqsa Martyrs Hospital following Israeli army airstrikes in the Nuseirat and Maghazi camps, in the central Gaza Strip, Thursday Jan. 2, 2025.(AP Photo/Abdel Kareem Hana)
A wounded youth is brought to Al-Aqsa Martyrs Hospital after Israeli army airstrikes targeted the Nuseirat and Maghazi camps in Deir al-Balah, central Gaza Strip, on Thursday, Jan. 2, 2025. (AP Photo/Abdel Kareem Hana)
A dead child is brought to Al-Aqsa Martyrs Hospital after Israeli army airstrikes targeted the Nuseirat and Maghazi camps, in Deir al-Balah, central Gaza Strip, Thursday, Jan. 2, 2025. (AP Photo/Abdel Kareem Hana)
Young men cheer as members of the new security forces, primarily fighters from Hayat Tahrir al-Sham (HTS), fire into the air in celebration after spending most of the day searching for militiamen loyal to ousted President Bashar Assad who refused to surrender their weapons to the new authorities in Homs, Syria, Thursday, Jan. 2, 2025. (AP Photo/Leo Correa)
People stand outside their homes at a residential area as members of the new security forces take part in an operation to detain, according to the state media, militiamen affiliated with ousted president Bashar Assad in Homs, Syria, Thursday, Jan. 2, 2025. (AP Photo/Leo Correa)
