PolyPid（2PV）株式概要ポリピッド社は、未解決の医療ニーズに対応するため、独自の高分子-脂質カプセル化マトリックス（PLEX）技術を用いて、標的、局所投与、徐放性の治療薬を開発するバイオ医薬品企業である。 詳細2PV ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長5/6過去の実績0/6財務の健全性3/6配当金0/6報酬収益は年間57.84%増加すると予測されています リスク分析キャッシュランウェイが1年未満である 過去1年間で株主の希薄化は大幅に進んだ 収益が 100 万ドル未満 ( $0 )German市場と比較して、過去 3 か月間の株価の変動が非常に大きい+1 さらなるリスクすべてのリスクチェックを見る2PV Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€4.37該当なし内在価値ディスカウントEst. Revenue$PastFuture-46m92016201920222025202620282031Revenue US$9.1Earnings US$1.3AdvancedSet Fair ValueView all narrativesPolyPid Ltd. 競合他社Cantourage GroupSymbol: XTRA:HIGHMarket cap: €76.1mMPH Health CareSymbol: DB:93M1Market cap: €110.0mBiofronteraSymbol: XTRA:B8FKMarket cap: €14.6mPEPTONIC medicalSymbol: DB:28LMarket cap: €560.2m価格と性能株価の高値、安値、推移の概要PolyPid過去の株価現在の株価US$4.3752週高値US$4.3852週安値US$3.11ベータ1.411ヶ月の変化14.10%3ヶ月変化n/a1年変化n/a3年間の変化n/a5年間の変化n/aIPOからの変化18.14%最新ニュースお知らせ • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026お知らせ • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.お知らせ • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.最新情報をもっと見るRecent updatesお知らせ • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026お知らせ • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.お知らせ • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.株主還元2PVDE PharmaceuticalsDE 市場7D7.9%3.0%2.8%1Yn/a23.4%1.4%株主還元を見る業界別リターン: 2PVがGerman Pharmaceuticals業界に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。リターン対市場: 2PV German市場に対してどのようなパフォーマンスを示したかを判断するにはデータが不十分です。価格変動Is 2PV's price volatile compared to industry and market?2PV volatility2PV Average Weekly Movement20.6%Pharmaceuticals Industry Average Movement6.4%Market Average Movement6.0%10% most volatile stocks in DE Market12.8%10% least volatile stocks in DE Market2.7%安定した株価: 2PVの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間の2PVのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト200872Dikla Czaczkes Akselbradwww.polypid.comポリピッド社は、アンメット・メディカル・ニーズに対応するため、独自のポリマー-脂質カプセル化マトリックス（PLEX）技術を用い、標的、局所投与、徐放性の治療薬を開発するバイオ医薬品企業である。主要な製品候補はD-PLEX100で、大きな切開を伴う腹部大腸手術を受ける患者における手術部位感染（SSI）の予防を目的とした重要な第3相確認試験中である。また、前臨床段階にある腫瘍内がん治療薬OncoPLEXも開発中である。同社は、固形がんを治療する製剤の開発に関してImmunoGenesis, Inc.と研究開発提携を結んでいる。ポリピッド社は2008年に設立され、イスラエルのペタティクバに本社を置いている。もっと見るPolyPid Ltd. 基礎のまとめPolyPid の収益と売上を時価総額と比較するとどうか。2PV 基礎統計学時価総額€82.36m収益（TTM）-€28.91m売上高(TTM)n/a0.0xP/Sレシオ-2.7xPER（株価収益率2PV は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計2PV 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$33.63m収益-US$33.63m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-1.76グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率9.1%2PV の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/26 20:14終値2026/05/26 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋PolyPid Ltd. 4 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。8 アナリスト機関Balaji PrasadBarclaysBalaji PrasadBarclaysGary NachmanBMO Capital Markets Equity Research5 その他のアナリストを表示
お知らせ • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026
お知らせ • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
お知らせ • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
お知らせ • May 06PolyPid Ltd. to Report Q1, 2026 Results on May 13, 2026PolyPid Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026
お知らせ • Apr 29PolyPid Ltd Presents Data From SHIELD II Phase 3 Trial Demonstrating Reduced Severity Of Surgical Site InfectionPolyPid Ltd. announced that it will present at the 45th Annual Meeting of the Surgical Infection Society, taking place on May 5-6, 2026, at the Coronado Island Marriott in Coronado, California. The presentation will focus on a detailed analysis of the ASEPSIS (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and prolonged Stay as inpatient) score data from the Company's Phase 3 SHIELD II trial of D-PLEX100. The ASEPSIS score is a validated, objective clinical scoring system used to assess the severity of surgical wound infections. It integrates parameters such as wound appearance, antibiotic use, drainage of pus, isolation of pathogenic bacteria, and length of hospital stay. As previously reported in the SHIELD II topline results, treatment with D-PLEX100 together with the standard of care resulted in a 64% relative risk reduction (p=0.0103) in the proportion of patients with an ASEPSIS score greater than 20, the threshold indicative of clinically significant wound infection, compared to the standard of care alone. Surgical Infection Society 2026 Annual Meeting Presentation Details: Title: Evaluation of ASEPSIS Score as a Secondary Endpoint in the Phase 3 SHIELD II Trial of D-PLEX100 in Colorectal Surgery; Session: Scientific Session III; Date/Time: Wednesday, May 6, 2026 | 8:00 a.m. – 9:00 a.m. PT; Location: Coronado Island Marriott, Coronado, California. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
お知らせ • Apr 14PolyPid Ltd Announces New Phase 3 Shield II Data Demonstrating D-Plex100 Sustained Local ReleasePolyPid Ltd. announced that the Company will present new pharmacokinetic data from the Phase 3 SHIELD II trial evaluating D-PLEX100 at the Congress of the European Society of Clinical Microbiology and Infectious Diseases Global 2026, taking place on April 17-21, 2026, in Munich, Germany. The abstract titled “Pharmacokinetics of local extended-release incisional doxycycline in patients undergoing abdominal colorectal surgery from the SHIELD II Phase 3 clinical trial,” was co-authored by Prof. Antonino Spinelli, Director of the Division of Colon and Rectal Surgery and a Professor of Surgery at Humanitas University, in Milan, Italy and PolyPid. Sustained and controlled release profile: Detectable doxycycline concentrations were observed for up to 763 hours (approximately 32 days), with no burst, following local application of D-PLEX100 during surgery. Minimal systemic exposure: Plasma doxycycline concentrations remained below 100 ng/mL, indicating negligible systemic levels relative to oral doxycycline administration where Cmax levels are approximately 16 to 26 times higher (1,613.3 ng/mL for 100 mg and 2,600 ng/mL for 200 mg doses). ESCMID Global 2026 Presentation Details Poster Title: Pharmacokinetics of Local Extended-Release Incisional Doxycycline in Patients undergoing Abdominal Colorectal Surgery from the SHIELD II Phase 3 Clinical Trial Presenter: Eyal Shoshani, VP Clinical Affairs, PolyPid Ltd. Lead Author: Prof. Antonino Spinelli, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy Poster Details: #P2740 (Presented at: Poster Hall B3) Session: 05b. Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring Date/Time: Sunday, April 19, 2026 | 12:00 – 13:30 CEST The abstract will be available once the conference concludes. D-PLEX100, PolyPid’s lead product candidate, is designed to provide local prolonged and controlled anti-bacterial activity directly at the surgical site to prevent surgical site infections (“SSIs”). Following the administration of D-PLEX100 into the surgical site, PolyPid’s delivery technology, Kynatrix, pairs with Active Pharmaceutical Ingredients, enabling a prolonged and continuous release of the broad-spectrum antibiotic doxycycline, resulting in a high local concentration of the drug for a period of 30 days for the prevention of SSIs, with additional potential to prevent SSIs caused by antibiotic-resistant bacteria at the surgical site. D-PLEX100 recently demonstrated positive results in the Phase 3 SHIELD II trial, achieving a statistically significant 60% (p=0.0013) relative risk reduction in SSI incidence following abdominal colorectal surgery with large incisions. D-PLEX100 received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the prevention of SSIs in patients undergoing elective colorectal surgery.
