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Peptilogics Begins Pivotal Trial of First-Ever Drug Designed to Cure Medical Device-Related Infections

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Peptilogics Begins Pivotal Trial of First-Ever Drug Designed to Cure Medical Device-Related Infections
News

News

Peptilogics Begins Pivotal Trial of First-Ever Drug Designed to Cure Medical Device-Related Infections

2026-03-10 19:05 Last Updated At:19:30

PITTSBURGH--(BUSINESS WIRE)--Mar 10, 2026--

Peptilogics, a surgical therapeutics company dedicated to curing and preventing devastating medical device-related infections (MDRI), has announced the enrollment of the first patient in the RETAIN Phase 2/3 registration trial by Dr. Toan Le at the University of Cincinnati Medical Center. The trial is evaluating PLG0206, a first-in-class anti-biofilm drug candidate, in patients with prosthetic joint infection (PJI), the first of multiple potential MDRI indications. PJI represents the largest unmet need in orthopedics and a significant entry point into a broader MDRI market that affects millions of patients annually.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310292373/en/

Approximately five million joint replacements are performed each year across the U.S., the U.K., and Europe. 1 In two percent of cases, a protective matrix called biofilm forms on implant surfaces, shielding bacteria from antibiotics and the immune system and resulting in PJI. 2 The condition can occur quickly or even years after surgery. The current standard of care for PJI calls for two-stage revision surgery, where the infected prosthesis is removed. This approach carries a 15–25 percent failure rate, subjects patients to multiple procedures and leads to 25 percent five-year mortality. 3,4,5 The estimated total economic burden of PJI is $20 billion annually in the U.S. alone. 1,2,6 These outcomes persist in PJI – and across all MDRI – because existing treatments consistently fail to eradicate the persister bacteria protected by the biofilm.

“RETAIN is a landmark trial that will determine whether PLG0206 can provide surgeons a proven, durable cure for prosthetic joint infection,” said Javad Parvizi, MD, FRCS, Professor of Orthopedic Surgery, Acibadem University, Istanbul, and past president of the American Association of Hip and Knee Surgeons. “Total joint arthroplasty is very successful in restoring function, mobility, and quality of life, but infection after joint replacement is a truly devastating complication that robs patients of that outcome and, in far too many cases, their lives. I’m excited about the promise of PLG0206 as a first-in-class treatment for patients with PJI, and as a potential solution for all medical device-related infections in the future.”

RETAIN is a randomized, double-blind, placebo-controlled, multi-center Phase 2/3 registration trial evaluating PLG0206 in patients undergoing DAIR (Debridement, Antibiotics, and Implant Retention) surgery to treat PJI following total knee arthroplasty (TKA). The study is designed to assess superiority versus standard of care, with a primary endpoint of treatment failure at 12 months and a key secondary endpoint of PJI-related surgical intervention at 12 months. The trial is anticipated to enroll up to 240 patients across up to 50 planned clinical sites.

The RETAIN trial builds on an earlier Phase 1 study establishing the safety profile of PLG0206 and a Phase 1B study demonstrating safety and preliminary efficacy in patients with PJI where only one of thirteen PLG0206-treated patients had a recurrence of infection by 12 months (a seven percent failure rate). 7,8 In contrast, a 12-month failure rate of 35 to 55 percent has been reported with current standard of care. 9,10

“Biofilm is the root cause of medical device-related infections, and no approved therapy has ever been designed to target it,” said Jonathan Steckbeck, Ph.D., Peptilogics CEO. “We built PLG0206 from the ground up as the first drug to penetrate biofilm and eradicate the persister bacteria protected by it. PJI is our first indication because it is the largest and most acute unmet need, but the biofilm biology is identical across all device categories. If we are successful in RETAIN, we will have demonstrated a platform with the potential to cure and prevent infections wherever a medical device is implanted – a multi-billion dollar category-defining therapeutic.”

There are 55 million people in the U.S. alone living with medical devices and implants which span joint replacements, cardiovascular assist devices, spinal fusion hardware, trauma fixation, hernia mesh, breast implants post mastectomy, and vascular grafts. 10,11,12 Across these categories, bacterial biofilm is the primary driver of serious device-related infections. No approved therapy has been specifically designed to target biofilm, leaving clinicians reliant on systemic antibiotics, repurposed generics, and surgical revision to manage infections that frequently recur.

PLG0206 acts against a broad range of bacteria including multi-drug-resistant pathogens, fits into existing surgical workflows, and offers low resistance potential. PLG0206 has received Qualified Infectious Disease Product (QIDP) designation, which provides five additional years of market exclusivity upon approval, as well as Orphan Drug and Fast Track designations from the U.S. Food & Drug Administration (FDA) for the treatment of Prosthetic Joint Infections (PJIs), reflecting the severity of the unmet need and the potential for an expedited path to market.

For more information on PLG0206 and the RETAIN trial, please visit https://peptilogics.com/pipeline/.

About the RETAIN Trial

(NCT07214311)

RETAIN is a Phase 2/3, randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of PLG0206 in patients undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for the treatment of periprosthetic joint infection (PJI) following Total Knee Arthroplasty (TKA). The trial is expected to enroll approximately 240 participants. The primary endpoint is treatment failure, assessed 12 months after DAIR. A key secondary endpoint is the need for PJI-related surgical intervention, also evaluated at 12 months post-treatment. For more information, visit https://clinicaltrials.gov/study/NCT07214311#study-overview.

About Peptilogics

Peptilogics is a surgical therapeutics company dedicated to curing and preventing devastating medical device-related infections (MDRI). Peptilogics’ lead candidate, PLG0206, is a first-in-class drug that targets biofilm, a protective bacterial matrix that is the root cause of device infections across surgical categories, and has no approved cure to date. PLG0206 is currently being evaluated in a Phase 2/3 registration trial for the treatment of prosthetic joint infection (PJI), the first of multiple potential indications to treat and prevent MDRI.

Forward-Looking Statements

This press release contains “forward-looking statements” that involve substantial risks, assumptions and uncertainties. Forward-looking statements are often identified by words such as, but not limited to, “believe,” “estimate,” “intend,” “may,” “plan,” “potentially,” “will,” “expect,” “enable,” “likely” or the negative of these terms or other similar expressions. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or Peptilogics, Inc. prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors. These forward-looking statements are made as of the date of this press release, and Peptilogics, Inc. assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

References

 

Peptilogics' PLG0206 is a first-in-class anti-biofilm drug candidate being studied in patients with prosthetic joint infection (PJI), the first of multiple potential medical device-related infections (MDRIs).

Peptilogics' PLG0206 is a first-in-class anti-biofilm drug candidate being studied in patients with prosthetic joint infection (PJI), the first of multiple potential medical device-related infections (MDRIs).

Iran fired drones and missiles at Israel and Gulf states Tuesday as Israeli Prime Minister Benjamin Netanyahu vowed his country will keep striking the Islamic Republic, saying the aim of the campaign was the popular overthrow of its government.

“Our aim is to bring the Iranian people to cast off the yoke of tyranny, ultimately it depends on them,” Netanyahu said during a meeting with Israel’s hospital and health system leaders. “But there is no doubt that with the actions taken so far, we are breaking their bones."

U.S. President Donald Trump sent contradictory signals about how long the war could last, fueling uncertainty that is causing markets to swing.

Iranian Parliament Speaker Mohammad Bagher Qalibaf dismissed any suggestion Tehran sought a ceasefire in the war and would keep fighting.

Trump late Monday told Republican lawmakers that the war was likely to be a “short excursion,” but hours later threatened in a social media post that the U.S. would dramatically increase attacks if Iran tried to close the Strait of Hormuz.

Here is the latest:

Qatar’s Defense Ministry reported that it has intercepted an incoming missile.

Qatar had warned the public to go inside Tuesday afternoon out of concern of an incoming Iranian attack.

Also, the United Arab Emirates said that its air defenses had been activated to intercept incoming fire from Iran.

Iranian security official Ali Larijani wrote a message on X after U.S. President Donald Trump threatened to attack Iran “TWENTY TIMES HARDER” if Tehran stopped oil flowing through the Strait of Hormuz.

Larijani wrote: “The sacrificial nation of Iran doesn’t fear your empty threats. Even those bigger than you couldn’t eliminate Iran. Be careful not to get eliminated yourself.”

Iran has been accused of plotting attempts to kill Trump in the past.

A spokesman for Iran’s paramilitary Revolutionary Guard has threatened to not allow “a single liter of oil” to leave the Persian Gulf.

Ali Mohamad Naeini has made the comment in a statement.

He says Iran “will not allow the export of even a single liter of oil from the region to the hostile side and its partners until further notice.”

“Their attempts to reduce and control oil and gas prices will be temporary and ineffective,” he said. “Trade in wartime conditions is subject to security considerations.”

A ship likely came under attack in the Persian Gulf off the coast of the United Arab Emirates’ capital, a center run by the British military says.

The possible attack on the bulk carrier would expand the radius of ongoing assaults against shipping by Iran during the war.

The United Kingdom Maritime Trade Operations center reported the incident, saying a captain aboard the vessel reported seeing “a splash and heard a loud bang in close proximity of a bulk carrier.”

Kremlin spokesman Dmitry Peskov says Russia remains ready to help broker an end to the war in the Middle East.

Following Russian President Vladimir Putin’s call on Monday with U.S. President Donald Trump, Peskov said that Russia’s mediation offers “are still on the table.”

He told reporters that “Russia is ready to provide assistance to the best of its ability and will be happy to do so.”

Israel’s military says it has launched new airstrikes targeting Iran’s capital, Tehran.

Witnesses reported hearing several explosions in the city as the Israelis began their airstrikes.

The Persian Gulf country was attacked with three missiles and a drone as Iran keeps up its strikes in the Middle East, authorities said.

One strike hit a residential building in Bahrain’s capital, Manama, killing a 29-year-old woman and wounding eight others, the Interior Ministry said.

Iran has repeatedly hit Bahrain, which hosts the U.S. 5th Fleet.

The group of industrial nations on Monday held off releasing oil stocks to bring down prices but are picking up the issue again with more discussions between their energy ministers on Tuesday, according to France.

France, which currently holds the G7’s rotating presidency, wants “to advance on that question, with one objective, which is to bring down prices,” government spokeswoman Maud Bregeon told broadcaster France Televisions.

“France is working on that for a very simple reason: If you put volume back into the market, you can have an impact on the lowering of prices,” Bregeon said.

French Finance Minister Roland Lescure said the G7 ministers will meet Tuesday afternoon by video call.

“It’s a process, we are working on it,” Lescure said. “All options are on the table.”

German Foreign Minister Johann Wadephul says there is no need now to send his country’s warships or other military hardware to Cyprus or the eastern Mediterranean.

An Iranian Shahed drone struck a British air base on Cyprus’ southern coast last week.

Wadephul lauded Greece, France and Italy for dispatching warships to the region as a “pragmatic step,” adding that Germany would augment a European force presence if needed.

Following talks with his Cypriot counterpart, Constantinos Kombos, Wadephul said he doesn’t have intelligence indicating “a real current threat” to Cyprus or another European country from the Iran war.

But he added “you can never predict what will happen the next day” with groups like Hezbollah.

Saudi oil company Aramco says it will reach capacity of its East-West pipeline “in a couple of days” to get its product out to the global market.

Amin Nasser, Aramco’s CEO and president, said the East-West pipeline has a daily capacity of 7 million barrels.

“We should be reaching capacity, in a couple of days. It’s all been going on the repositioning of tankers from the East to West,” Nasser said. “You know, this crisis happened all of a sudden, and tankers need to reposition to the West coast for loading.”

He added: “The situation at the Strait of Hormuz is blocking sizable volumes of oil from the whole region.”

The East-West pipeline sends oil to the Red Sea for transport. Saudi Aramco operates the pipeline from the Aqaiq oil processing center near the Persian Gulf to the Yanbu port on the Red Sea, avoiding the chokepoint of the Strait of Hormuz.

Amin Nasser, the president and CEO of Aramco, said the firm remained “focused on safety and meeting our commitments.”

“That situation continues to evolve, and the safety of our people and our operations remain our highest priorities,” Nasser said.

He did not immediately elaborate on any effects from the war on the company’s output.

Nasser hinted at global oil markets being squeezed the longer the Iran war goes on and shipments from the Mideast being affected.

“Given the current geopolitical situation, we may see inventories eroding and being drawn down faster as shipments are being curtailed from the region,” he said. “This is at a time when current global spare capacity remains extremely low.”

That likely could push the price per barrel globally even higher, translating to higher costs for gasoline and jet fuel.

Prime Minister Benjamin Netanyahu vowed Tuesday that Israel will continue striking Iran.

“Our aim is to bring the Iranian people to cast off the yoke of tyranny, ultimately it depends on them,” Netanyahu said during a meeting with Israel’s hospital and health system leaders.

“But there is no doubt that with the actions taken so far, we are breaking their bones,” he said.

Thailand’s Prime Minister Anutin Charnvirakul told government agencies and state companies to begin having staff not in public facing roles to work from home.

The government said Tuesday that Thailand was also suspending overseas training and study trips.

The announcement comes as countries in Southeast Asia move to counter disruptions to oil and gas supplies from the war in the Middle East.

The Vietnamese government ordered similar measures, but also urged people to limit private use of their vehicles.

Fuel prices have climbed and long lines have formed outside filling stations as drivers and motorcycle riders rush to ensure they can fill their tanks.

Iran’s parliament speaker on Tuesday dismissed any suggestion Tehran sought a ceasefire in the war.

“We are definitely not looking for a ceasefire; we believe that the aggressor should be punched in the mouth so that he learns a lesson so that he will never think of attacking our beloved Iran again,” Mohammad Bagher Qalibaf wrote on X.

“The Zionist regime sees its shameful existence in the continuation of the cycle of ‘war-negotiation-ceasefire and then war again’ to consolidate its dominance. We will break this cycle,” he wrote.

The Israeli military said Tuesday it killed three Palestinians in Gaza late Monday.

The Palestinians approached Israeli troops near the temporary line that Israel withdrew to at the start of the October 2025 ceasefire. The Yellow Line marks the Israel-controlled area in eastern Gaza.

Since the start of the ceasefire, at least 80 Palestinians have been killed near the Yellow Line after the Israeli military accused them of approaching and endangering soldiers.

Israel’s military said it detected an Iranian missile launch targeting the country Tuesday morning.

Sirens were heard in Jerusalem and explosions could be heard in Tel Aviv as Israel’s military worked to intercept the fire.

India’s oil ministry has set up a committee to review supplies of commercial cooking gas as the hospitality sector experiences a shortage of liquefied petroleum gas cylinders.

India relies heavily on oil and gas shipped through the Strait of Hormuz. Iran has attacked several ships in the strait and threatened any ships that try to pass through, effectively closing it.

Industry groups in India say restaurants in some major cities including Mumbai and Bengaluru are struggling to secure cooking gas cylinders. They warn some eateries could shut within days if supplies are not restored.

Indian authorities have prioritized LPG supplies for household use, tightening availability for commercial users such as hotels and restaurants.

Azerbaijan has sent humanitarian aid to Iran, Azerbaijani officials said Monday.

The aid includes 10 tons of flour, six tons of rice, more than two tons of sugar, over four tons of water, about 600 kilograms of tea and about two tons of medicines and medical supplies, according to officials.

Iran’s judiciary is warning its local media about what and how it reports as the war with Israel and the United States goes on.

That was a comment made by judiciary spokesman Asghar Jahangir as reported by the state-run IRNA news agency.

It said Jahangir said local outlets “that did not comply with security issues and had taken videos and photos of certain places solely for the purpose of informing were given the necessary warnings.”

“If this happens again, the necessary legal measures will be taken,” he said, without elaborating.

Iran has shut off the internet during the war and may be restricting reporting to hide what has been struck so far.

Turkey’s Defense Ministry said Tuesday the Patriot missile defense system is being deployed in Malatya province, which hosts a NATO radar base.

The move follows NATO defenses intercepting a second ballistic missile fired from Iran that entered Turkish airspace Monday.

The Israeli military on Tuesday reiterated the call for all residents of southern Lebanon to evacuate their homes as it planned to “operate forcefully” in the southern area against Hezbollah.

Israel issued similar warnings during its war with Hezbollah in 2003-2024, displacing hundreds of thousands of people.

The Israeli military said Tuesday it had completed a series of strikes targeting Hezbollah’s financial arm, al-Qard Al-Hasan.

Israel says Hezbollah uses al-Qard al-Hasan to finance its military activities.

Israel targeted several of the group’s branches in southern and eastern Lebanon last week.

Saudi Arabian oil company Aramco reported 2025 profits of $104 billion, down from the year before as the Iran war has seen its fields and facilities targeted.

Aramco released its annual results Tuesday. It planned to brief investors later in the day as the war that began Feb. 28 has seen Iranian drones and missiles target its facilities.

Aramco, formally known as the Saudi Arabian Oil Co., reported profits of $110 billion in 2024.

Aramco said its 2025 revenues were $445 billion, down from $480 billion in 2024.

The United Arab Emirates will lower the volume of missile alerts sent to mobile phones in the overnight hours.

The UAE’s National Emergency Crisis and Disasters Management Authority made the announcement late Monday night, saying that the loud blaring alarm would sound on phones from 9 a.m. until 10:30 p.m.

A standard text message chime would sound from 10:30 p.m. until 9 a.m., it said.

Egypt hiked fuel prices by up to 17% on Tuesday as the war in the Middle East sent prices of oil soaring.

According to the Petroleum Ministry the cost of a liter of diesel, which is heavily relied on for public transport, increased by more than 17%. The price of the 92-octane gasoline rose by 15% and 95-octane gasoline increased by 14%.

Flames rise from an oil storage facility south of the capital Tehran as strikes hit the city during the U.S.–Israel military campaign, Iran, Saturday, March 7, 2026. (AP Photo/Vahid Salemi)

Flames rise from an oil storage facility south of the capital Tehran as strikes hit the city during the U.S.–Israel military campaign, Iran, Saturday, March 7, 2026. (AP Photo/Vahid Salemi)

Iraqis hold a portrait of the new successor to Supreme Leader, Ayatollah Mojtaba Khamenei at a bridge leading to the fortified Green Zone where the U.S. embassy is located in Baghdad, Iraq, Monday, March 9, 2026. (AP Photo/Hadi Mizban)

Iraqis hold a portrait of the new successor to Supreme Leader, Ayatollah Mojtaba Khamenei at a bridge leading to the fortified Green Zone where the U.S. embassy is located in Baghdad, Iraq, Monday, March 9, 2026. (AP Photo/Hadi Mizban)

A coffin is carried during the funeral of mostly children killed in a strike Feb. 28 at a girls' elementary school in Minab, Iran, Tuesday, March 3, 2026. (Abbas Zakeri/Mehr News Agency via AP)

A coffin is carried during the funeral of mostly children killed in a strike Feb. 28 at a girls' elementary school in Minab, Iran, Tuesday, March 3, 2026. (Abbas Zakeri/Mehr News Agency via AP)

This image taken from video provided by Iran state TV shows Mojtaba Khamenei, a son of Iran's slain supreme leader, who has been named as the Islamic Republic's next ruler, authorities announced Monday, March 9, 2026. (Iran state TV via AP)

This image taken from video provided by Iran state TV shows Mojtaba Khamenei, a son of Iran's slain supreme leader, who has been named as the Islamic Republic's next ruler, authorities announced Monday, March 9, 2026. (Iran state TV via AP)

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