{"id":2192,"date":"2026-01-14T16:00:37","date_gmt":"2026-01-14T14:00:37","guid":{"rendered":"http:\/\/jjpbiologics.wpengine.com\/?p=2192"},"modified":"2026-04-29T15:53:24","modified_gmt":"2026-04-29T13:53:24","slug":"jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist","status":"publish","type":"post","link":"https:\/\/jjpbiologics.com\/pl\/jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist\/","title":{"rendered":"JJP BIOLOGICS ANNOUNCES POSITIVE TOP-LINE PHASE I TRIAL RESULTS OF JJP-1212, ITS ANTI-CD89 ANTAGONIST"},"content":{"rendered":"<ul class=\"wp-block-list\">\n<li>Favorable safety, tolerability, pharmacokinetic and pharmacodynamic profiles validate and significantly de-risk the program<\/li>\n\n\n\n<li>Supports the feasibility of intravenous and subcutaneous dosing regimens in upcoming clinical development stages<\/li>\n\n\n\n<li>Confirms JJP-1212 as a versatile antibody with potential for use across multiple immune-mediated indications in which IgA contributes to disease pathology<\/li>\n<\/ul>\n\n\n\n<p><strong>7 Stycznia 2026<\/strong><br><strong>JJP Biologics, a clinical-stage biotechnology company <\/strong>that specializes in the development of innovative biologics, today announces positive top-line results from its Phase I clinical trial of JJP-1212, a potential first-in-class anti-CD89 antagonist that is being developed to treat autoimmune, inflammatory, and fibrotic diseases where pathogenic IgA autoantibodies are a key part of the disease mechanism.<br>Wspomniane badanie (numer badania UE: 2023-508661-33-00) zosta\u0142o przeprowadzone na populacji zdrowych, pe\u0142noletnich ochotnik\u00f3w i by\u0142o realizowane jako randomizowane, podw\u00f3jnie za\u015blepione badanie kontrolowane placebo. Jego celem by\u0142a ocena bezpiecze\u0144stwa, tolerancji, farmakokinetyki (PK) i farmakodynamiki (PD) cz\u0105steczki JJP-1212 u zdrowych, doros\u0142ych ochotnik\u00f3w. Pomy\u015blnie zako\u0144czono obie cz\u0119\u015bci badania, obejmuj\u0105ce podanie pojedynczych, jak i wielokrotnych dawek rosn\u0105cych.<br>Osi\u0105gni\u0119to wszystkie pierwszorz\u0119dowe punkty ko\u0144cowe badania. Analiza statystyczna po od\u015blepieniu danych wykaza\u0142a pozytywny stosunek korzy\u015bci do ryzyka dla profilu bezpiecze\u0144stwa i tolerancji JJP-1212:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Zosta\u0142 zarejestrowany przewidywany profil farmakokinetyczny, z typowym okresem p\u00f3\u0142trwania przeciwcia\u0142a monoklonalnego wynosz\u0105cym oko\u0142o trzech tygodni<\/li>\n\n\n\n<li>Dane dotycz\u0105ce obsadzenia receptora CD89 potwierdzi\u0142y korzystny profil farmakodynamiczny, kt\u00f3ry zosta\u0142 okre\u015blony jako przewidywalny i odwracalny. Potwierdza to molekularny mechanizm dzia\u0142ania JJP-1212 oraz zasadno\u015b\u0107 u\u017cycia w dalszych badaniach z udzia\u0142em pacjent\u00f3w.<\/li>\n\n\n\n<li>Pawe\u0142 Szczepa\u0144ski, prezes Zarz\u0105du JJP Biologics, powiedzia\u0142: \u201ePozytywne wyniki p\u0142yn\u0105ce z fazy I badania klinicznego, w ramach naszego wiod\u0105cego programu badawczego, stanowi\u0105 wa\u017cny kamie\u0144 milowy dla JJP Biologics. Potwierdzaj\u0105 one trafno\u015b\u0107 naszego innowacyjnego podej\u015bcia do mechanizmu leczenia ukierunkowanego na receptor CD89 w chorobach autoimmunologicznych. Robimy du\u017ce post\u0119py i po uzyskaniu kluczowych danych dotycz\u0105cych zdrowych ochotnik\u00f3w, z niecierpliwo\u015bci\u0105 oczekujemy na kolejne wyniki z naszego badania fazy Ib z udzia\u0142em pacjent\u00f3w z linijn\u0105 dermatoz\u0105 IgA. Planujemy opublikowa\u0107 je w pierwszym kwartale 2026 roku. W trzecim kwartale 2026 roku zamierzamy r\u00f3wnie\u017c rozpocz\u0105\u0107 szeroko zakrojony program bada\u0144 klinicznych fazy II\u201d.<\/li>\n<\/ul>\n\n\n\n<p>Dr Sohail Ahmed, MBA, Dyrektor Medyczny w JJP Biologics, doda\u0142: \u201eKorzystny profil bezpiecze\u0144stwa i przewidywalne parametry farmakologiczne uzyskane w naszym badaniu fazy I znacz\u0105co zmniejszaj\u0105 ryzyko dla kolejnych etap\u00f3w rozwoju klinicznego cz\u0105steczki JJP-1212. Wzmacniaj\u0105 r\u00f3wnie\u017c nasz\u0105 wiar\u0119 w potencja\u0142 antagonisty anty-CD89 w leczeniu wielu chor\u00f3b IgA-zale\u017cnych. Co wa\u017cne, ten ukierunkowany mechanizm daje pacjentom, z chorobami autoimmunologicznymi, zapalnymi i w\u0142\u00f3kniej\u0105cymi, mo\u017cliwo\u015b\u0107 osi\u0105gni\u0119cia istotnej kontroli choroby, unikaj\u0105c jednocze\u015bnie szeroko poj\u0119tej immunosupresji zwi\u0105zanej z obecnymi metodami leczenia\u201d.<br>Opr\u00f3cz profilu bezpiecze\u0144stwa potwierdzonego u zdrowych ochotnik\u00f3w, firma JJP Biologics aktywnie bada potencja\u0142 terapeutyczny cz\u0105steczki JJP-1212 w mi\u0119dzynarodowej, otwartej kohorcie pacjent\u00f3w z linijn\u0105 chorob\u0105 IgA, rzadk\u0105, immunologiczn\u0105, p\u0119cherzow\u0105 chorob\u0105 sk\u00f3ry. Cele badania koncentruj\u0105 si\u0119 na bezpiecze\u0144stwie, immunogenno\u015bci, tolerancji i wczesnych danych dotycz\u0105cych skuteczno\u015bci terapii w tej populacji pacjent\u00f3w. Pierwsi uczestnicy badania otrzymali trzy dawki leku JJP-1212, a sp\u0142ywaj\u0105ce dane wskazuj\u0105 na obiecuj\u0105cy profil bezpiecze\u0144stwa i skuteczno\u015bci.<\/p>\n\n\n\n<p><strong>About JJP Biologics<\/strong><\/p>\n\n\n\n<p>JJP Biologics to firma biotechnologiczna na etapie dzia\u0142aj\u0105ca na etapie bada\u0144 klinicznych, specjalizuj\u0105ca si\u0119 w rozwoju innowacyjnych lek\u00f3w biologicznych. Misj\u0105 JJP Biologics jest \u201eznalezienie bezpiecznych i skutecznych lek\u00f3w odpowiadaj\u0105cych na niezaspokojone potrzeby pacjent\u00f3w, dla kt\u00f3rych \u2013 jak wierzymy \u2013 mo\u017cemy dzia\u0142a\u0107 lepiej\u201d. JJP Biologics to prywatnie finansowana firma biotechnologiczna, kt\u00f3ra prowadzi prace nad w\u0142asnymi kandydatami na leki, a tak\u017ce projekty realizowane we wsp\u00f3\u0142pracy z partnerami naukowymi. Programy firmy koncentruj\u0105 si\u0119 na og\u00f3lnych szlakach odpowiedzi immunologicznej, kt\u00f3re maj\u0105 zastosowanie w chorobach autoimmunologicznych i nowotworach. Aktualna lista JJP Biologics obejmuje szereg program\u00f3w, w tym najbardziej zaawansowany program JJP-1212 w autoimmunologii oraz program JJP-1008 w immunoonkologii.<br>Projekt JJP-1212 jest wsp\u00f3\u0142finansowany z bud\u017cetu pa\u0144stwa przez Polsk\u0105 Agencj\u0119 Bada\u0144 Medycznych (nr: 2022\/ABM\/05\/00011).<\/p>\n\n\n\n<p><strong>Program JJP-1212<\/strong><br><strong><br><\/strong>JJP-1212 to pierwszy w swojej klasie antagonista IgG4-\u03ba CD89, kt\u00f3ry zosta\u0142 opracowywany w celu leczenia szerokiego zakresu chor\u00f3b autoimmunologicznych, zapalnych i zw\u0142\u00f3knieniowych, w kt\u00f3rych przeciwcia\u0142a IgA odgrywaj\u0105 istotn\u0105 rol\u0119 patogenn\u0105 (np. reumatoidalne zapalenie staw\u00f3w, tocze\u0144 rumieniowaty uk\u0142adowy, idiopatyczne w\u0142\u00f3knienie p\u0142uc, opryszczkowe zapalenie sk\u00f3ry, nieswoiste zapalenia jelit, nefropatia IgA i zapalenie naczy\u0144 IgA). W pa\u017adzierniku 2022 roku Komisja Europejska przyzna\u0142a JJP-1212 status sierocego produktu leczniczego w leczeniu linijnej choroby IgA. Obecnie trwa otwarte badanie kliniczne cz\u0105steczki JJP-1212 w tym w\u0142a\u015bnie wskazaniu.<\/p>\n\n\n\n<p>W celu uzyskania dalszych informacji prosimy o kontakt:<strong>\u00a0<a href=\"mailto:info@jjpbiologics.com\">info@jjpbiologics.com<\/a>\u00a0<\/strong><br>Po\u0142\u0105cz si\u0119 z nami na LinkedIn\u00a0<em>Be a smart goose<\/em>\u00a0<a href=\"https:\/\/lnkd.in\/eZV3ZbS9\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>https:\/\/lnkd.in\/eZV3ZbS9<\/strong><\/a><\/p>\n\n\n\n<p><a href=\"http:\/\/jjpbiologics.com\/wp-content\/uploads\/2026\/04\/JJP-Biologics_JJP1212_HV_www_POL_fin_260114.pdf\">Download as PDF file >><\/a><\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>January 7, 2026JJP Biologics, a clinical-stage biotechnology company that specializes in the development of innovative biologics, today announces positive top-line&hellip;<\/p>","protected":false},"author":990005,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5],"tags":[],"class_list":["post-2192","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v21.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>JJP BIOLOGICS ANNOUNCES POSITIVE TOP-LINE PHASE I TRIAL RESULTS OF JJP-1212, ITS ANTI-CD89 ANTAGONIST - JJP Biologics<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jjpbiologics.com\/pl\/jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" 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Biologics"},"image":{"@id":"https:\/\/jjpbiologics.com\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/jjpbiologics.com\/#\/schema\/person\/85e5b4f7346f1b3e0e153562849f7a43","name":"jjp","image":{"@type":"ImageObject","inLanguage":"pl-PL","@id":"https:\/\/jjpbiologics.com\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/7af8c453e36d80c5694e711800454903b7530678990eb7442d82d1b8c1f95609?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/7af8c453e36d80c5694e711800454903b7530678990eb7442d82d1b8c1f95609?s=96&d=mm&r=g","caption":"jjp"},"url":"https:\/\/jjpbiologics.com\/pl\/author\/jjp\/"}]}},"featured_image_src":" ","featured_image_src_square":" ","author_info":{"display_name":"jjp","author_link":"https:\/\/jjpbiologics.com\/pl\/author\/jjp\/"},"category_info":"<a href=\"https:\/\/jjpbiologics.com\/pl\/category\/news\/\" rel=\"category tag\">News<\/a>","tags_info":"","social_share_info":"<a data-share=\"facebook\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https:\/\/jjpbiologics.com\/pl\/jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist\/\" class=\"pl-facebook-share social-share-default pl-social-share\" target=\"_blank\"><i class=\"fab fa-facebook-f\" aria-hidden=\"true\"><\/i><\/a><a data-share=\"twitter\" href=\"https:\/\/twitter.com\/share?url=https:\/\/jjpbiologics.com\/pl\/jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist\/\" class=\"pl-twiiter-share social-share-default pl-social-share\" target=\"_blank\"><i class=\"fab fa-twitter\" aria-hidden=\"true\"><\/i><\/a><a data-share=\"linkedin\" href=\"https:\/\/www.linkedin.com\/shareArticle?url=https:\/\/jjpbiologics.com\/pl\/jjp-biologics-announces-positive-top-line-phase-i-trial-results-of-jjp-1212-its-anti-cd89-antagonist\/\" class=\"pl-linkedin-share social-share-default pl-social-share\" target=\"_blank\"><i class=\"fab fa-linkedin-in\" aria-hidden=\"true\"><\/i><\/a>","wordExcerpt_info":"<p><!-- wp:list --><\/p>\n<ul class=\"wp-block-list\"><!-- wp:list-item --><\/p>\n<li>Favorable safety, tolerability, pharmacokinetic and pharmacodynamic profiles validate and significantly de-risk the program<\/li>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<li>Supports the feasibility of intravenous and subcutaneous dosing regimens in upcoming clinical development stages<\/li>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<li>Confirms JJP-1212 as a versatile antibody with potential for use across multiple immune-mediated indications in which IgA contributes to disease pathology<\/li>\n<p><!-- \/wp:list-item --><\/ul>\n<p><!-- \/wp:list --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><strong>January 7, 2026<\/strong><br \/><strong>JJP Biologics, a clinical-stage biotechnology company <\/strong>that specializes in the development of innovative biologics, today announces positive top-line results from its Phase I clinical trial of JJP-1212, a potential first-in-class anti-CD89 antagonist that is being developed to treat autoimmune, inflammatory, and fibrotic diseases where pathogenic IgA autoantibodies are a key part of the disease mechanism.<br \/>The trial (EU Trial Number: 2023-508661-33-00) was a randomized, double-blind, and placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JJP-1212 in healthy volunteers. Both the single and multiple ascending dose parts were successfully completed.<br \/>All primary endpoints of the trial were met. Unblinded statistical analysis demonstrated a favorable outcome with regards to the safety and tolerability profile of JJP-1212:<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:list --><\/p>\n<ul class=\"wp-block-list\"><!-- wp:list-item --><\/p>\n<li>Favorable PK profile with a typical monoclonal antibody half-life of approximately three weeks<\/li>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<li>Receptor occupancy data confirmed target engagement and that the PD effect is both predictable and reversible, validating the mechanism of action of JJP-1212.<\/li>\n<p><!-- \/wp:list-item --><\/p>\n<p><!-- wp:list-item --><\/p>\n<li>Pawel Szczepa\u0144ski, Chief Executive Officer at JJP Biologics, said: \u201cThese positive top-line Phase I results for JJP-1212, our lead asset, represent a significant milestone for JJP Biologics, strongly validating our innovative approach to targeting CD89 in autoimmune diseases. We are making great progress and, following this key data milestone in healthy volunteers, we look forward to reporting the next set of results from our Phase 1b trial in Linear IgA Disease in Q1 2026 and initiating a broad clinical program of Phase 2 trials by Q3 2026.\u201d<\/li>\n<p><!-- \/wp:list-item --><\/ul>\n<p><!-- \/wp:list --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>Sohail Ahmed, MD, MBA, Chief Medical Officer at JJP Biologics, added: \u201cThe favorable safety profile and predictable pharmacological parameters from our Phase I trial significantly de-risk the JJP-1212 program and reinforce our confidence in this promising anti-CD89 antagonist&#8217;s potential across multiple IgA-mediated diseases. Importantly, this targeted mechanism offers the possibility for patients with autoimmune, inflammatory, and fibrotic diseases to achieve meaningful disease control while avoiding the broad immunosuppression associated with current treatments.\u201d<br \/>In addition to the safety profile established in healthy volunteers, JJP Biologics is actively investigating the therapeutic potential of JJP-1212 in an international, open-label cohort of patients with Linear IgA Disease, a rare immune-mediated blistering skin disease. The objectives of the trial are focused on safety, immunogenicity, tolerability, and early signs of efficacy in this target population. The initial patients have received three doses of JJP-1212, with emerging data demonstrating promising safety and efficacy.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><strong>About JJP Biologics<\/strong><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>JJP Biologics is a clinical-stage biotechnology company that specializes in the development of innovative biologics. JJP Biologics is driven by its mission \u201cto find safe and effective medicines addressing the unmet needs of patients for whom we believe we can do better\u201d. JJP Biologics is a privately funded biotech which pursues the development of its own product candidates as well as projects executed in cooperation with scientific partners. The company\u2019s programs target general immune pathways that have application in autoimmune diseases and cancer. JJP Biologics currently has a range of programs including the most advanced JJP-1212 program for autoimmunity and JJP-1008 program for immune-oncology.<br \/>The JJP-1212 Project is co-financed by the state budget by the Polish Medical Research Agency (No: 2022\/ABM\/05\/00011).<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><strong>About JJP-1212<\/strong><br \/><strong><br \/><\/strong>JJP-1212 is a first-in-class IgG4-\u03ba CD89 antagonist that is being developed to treat a wide range of autoimmune, inflammatory, and fibrotic diseases where IgA antibodies are known to have significant pathogenic involvement (e.g., rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, dermatitis herpetiformis, inflammatory bowel disease, IgA nephropathy, and IgA vasculitis). JJP-1212 was designated an Orphan Medicinal Product in October 2022 by the European Commission for the treatment of Linear IgA Disease. An open-label trial with JJP-1212 for this indication is ongoing.<\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p>For further information, please contact:<strong>\u00a0<a href=\"mailto:info@jjpbiologics.com\">info@jjpbiologics.com<\/a>\u00a0<\/strong><br \/>Follow us on LinkedIn:\u00a0<em>Be a smart goose<\/em>\u00a0<a href=\"https:\/\/lnkd.in\/eZV3ZbS9\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>https:\/\/lnkd.in\/eZV3ZbS9<\/strong><\/a><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><a href=\"http:\/\/jjpbiologics.com\/wp-content\/uploads\/2026\/04\/JJP-Biologics_JJP1212_HV_www_ENG_fin_260107.pdf\">Download as PDF file &gt;&gt;<\/a><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n<p><!-- wp:paragraph --><\/p>\n<p><!-- \/wp:paragraph --><\/p>\n","comment_info":"No Comments","_links":{"self":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/users\/990005"}],"replies":[{"embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/comments?post=2192"}],"version-history":[{"count":0,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/posts\/2192\/revisions"}],"wp:attachment":[{"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/media?parent=2192"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/categories?post=2192"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jjpbiologics.com\/pl\/wp-json\/wp\/v2\/tags?post=2192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}