Datum | Källa | Rubrik | Typ | Alternativ |
---|---|---|---|---|
2023-05-26 | Lipidor | Lipidor updates on development of AKP02 | Pressreleaser | Ladda ner | Visa Stäng |
Pressreleaser |
Lipidor updates on development of AKP02STOCKHOLM, Sweden, 26th May 2023 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) is targeting a new Phase III study of the drug candidate AKP02 in 2024. Data from the earlier completed clinical study with AKP02 has been analyzed, and a way forward is clear. On 28th October 2022, Lipidor announced that the combination product AKP02 for the treatment of psoriasis did not fully meet the Phase III study’s primary endpoint of non-inferiority compared to the reference product. The study compared AKP02 with Enstilar, the market-leading product for topical treatment of mild to moderate psoriasis. The products contain the same active ingredients, calcipotriol and betamethasone dipropionate. Work on the formulation AKP02 was very close to achieving equivalent therapeutic efficacy with the reference product. An in-depth analysis, examining why the compared preparations differed in efficacy, has produced an explanatory model that is now undergoing a verification program. The model is based on the interaction of the formulation with the different skin layers, and how this affects the deposition and efficacy of the active substances. An updated AKP02 formulation with optimized properties is now being externally verified, together with a number of reference formulations. The partial results extracted so far in the preclinical work clearly indicate that the proposed corrections provide the desired effect. Work continues to provide further support for the change in formulation and thus increase the chances of success in a new study. ”The AKVANO® technology has been developed to provide a flexible platform that can be adapted to the needs of the specific application,” says Jan Holmbäck, CSO of Lipidor. “At the same time, we can maintain the basic advantages of the formulations such as solubility, sprayability, no need to touch, and quick drying. The experiments of the last few months have strengthened our confidence in the potential of the technology and also given us new insights.” A great need Psoriasis is a chronic autoimmune disease that affects, among other things, the process of skin cell formation. The disease is characterized by a vigorous formation of new skin cells and can vary in severity (mild/moderate/severe). Psoriasis is one of the most common public diseases. In Sweden alone, about 300,000 people are estimated to have some form of psoriasis (Source: Psoriasis Association) and the prevalence is 2-3% globally in a market that grows by 6.5% annually. Living with psoriasis can involve different types of challenges and Lipidor sees great opportunities to contribute to an improved everyday life for patients through AKP02, a treatment that can be delivered in spray format via Lipidor’s patented AKVANO® platform. Key milestones and timeline ahead It is with confidence that the company is working on a plan to conduct a new Phase III study for AKP02. Already in June, a scientific advisory meeting with the Swedish Medical Products Agency will be held to confirm the continued development plan. In parallel, commercial dialogues, procurement work, and exploratory talks on financing are ongoing. After the summer, the plan is to start a process for a larger financing round, with the goal of conducting a new Phase III study in 2024. The company is still in positive dialogues with RELIFE about the future. Publication The information was provided for publication by Lipidor’s CEO on 26 May 2023 at 1.15pm (CEST). |
||||
2023-05-26 | Lipidor | Lipidor uppdaterar om utvecklingen för AKP02 | Pressreleaser | Ladda ner | Visa Stäng |
|
||||
2023-05-11 | Lipidor | Lipidor AB (publ) publishes interim report for Q1 2023 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-05-11 | Lipidor | Lipidor AB (publ) offentliggör delårsrapport för första kvartalet 2023 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-05-09 | Lipidor | NOTICE OF ANNUAL GENERAL MEETING IN LIPIDOR AB (PUBL) | Pressreleaser | Ladda ner | Visa Stäng |
|
||||
2023-05-09 | Lipidor | KALLELSE TILL ÅRSSTÄMMA I LIPIDOR AB (PUBL) | Pressreleaser | Ladda ner | Visa Stäng |
|
||||
2023-04-26 | Lipidor | Lipidor AB (publ) offentliggör årsredovisning för 2022 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-04-26 | Lipidor | Lipidor AB (publ) publishes annual report for 2022 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-02-22 | Lipidor | Lipidor AB (publ) publishes year-end report for 2022 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-02-22 | Lipidor | Lipidor AB (publ) offentliggör bokslutskommuniké för 2022 | Rapporter | Ladda ner | Visa Stäng |
|
||||
2023-01-17 | Lipidor | Kommuniké från extra bolagsstämma i Lipidor AB (publ) | Analyser | Ladda ner | Visa Stäng |
|
||||
2023-01-17 | Lipidor | Bulletin from the extraordinary general meeting of Lipidor AB (publ) | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-23 | Lipidor | KALLELSE TILL EXTRA BOLAGSSTÄMMA I LIPIDOR AB (PUBL) | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-23 | Lipidor | NOTICE OF EXTRAORDINARY GENERAL MEETING IN LIPIDOR AB (PUBL) | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-23 | Lipidor | The Board of Lipidor resolves to summon an Extraordinary General Meeting for approval of the sale of subsidiary shares to major owners | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-23 | Lipidor | Styrelsen i Lipidor beslutar om att kalla till extra bolagsstämma för godkännande av försäljning av dotterbolagsaktier till större ägare | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-14 | Lipidor | Lipidor säkrar bryggfinansiering om minst 5 MSEK genom lån och försäljning av dotterbolagsaktier samt vidtar åtgärder för kostnadsbesparing inklusive uppsägningar av personal | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-14 | Lipidor | Lipidor secures bridge financing of at least SEK 5 million through loans and subsidiary share sales, and takes cost-saving measures including staff layoffs | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-08 | Lipidor | Lipidor presents Nomination Committee | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-12-08 | Lipidor | Lipidor presenterar valberedningen | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-11-23 | Lipidor | Lipidor AB (publ) offentliggör delårsrapport för tredje kvartalet 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-11-23 | Lipidor | Lipidor AB (publ) publishes interim report for third quarter 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-11-15 | Lipidor | Lipidor lämnar uppdatering efter utfall av Fas III-studien med psoriasiskandidaten AKP02 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-11-15 | Lipidor | Lipidor provides update following outcome of Phase III study of psoriasis candidate AKP02 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-10-28 | Lipidor | Lipidor announces results from the company's clinical Phase III study of AKP02 for psoriasis | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-10-28 | Lipidor | Lipidor meddelar resultat från bolagets kliniska Fas III-studie av AKP02 mot psoriasis | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-10-07 | Lipidor | Emollivet reaches milestone of over 1,000 products sold and prepares for scaled-up production | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-10-07 | Lipidor | Emollivet når milstolpe med över 1000 sålda produkter och förbereder nu för uppskalad produktion | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-09-29 | Lipidor | Lipidor uppdaterar om sin kliniska Fas III-studie med psoriasiskandidaten AKP02 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-09-29 | Lipidor | Lipidor updates on Phase III clinical study of psoriasis candidate AKP02 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-25 | Lipidor | Lipidor utser Charlotta Ekman som ny Chief Financial Officer | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-25 | Lipidor | Lipidor appoints new CFO Charlotta Ekman | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-24 | Lipidor | Lipidor AB (publ) publishes interim report for second quarter 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-24 | Lipidor | Lipidor AB (publ) offentliggör delårsrapport för andra kvartalet 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-23 | Lipidor | Samtliga patienter i Lipidors Fas III-studie med psoriasiskandidaten AKP02 är färdigbehandlade | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-08-23 | Lipidor | All patients in Lipidor's Phase III study with psoriasis candidate AKP02 have completed treatment | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-07-11 | Lipidor | Lipidor's Phase III study of AKP02 for treatment of psoriasis now fully recruited, results expected Q3 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-07-11 | Lipidor | Lipidors Fas III-studie med AKP02 för behandling av psoriasis är fullrekryterad, resultat väntas under Q3 2022 | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-06-02 | Lipidor | Bulletin from the annual general meeting of Lipidor AB (publ) | Analyser | Ladda ner | Visa Stäng |
|
||||
2022-06-02 | Lipidor | Kommuniké från årsstämma i Lipidor AB (publ) | Analyser | Ladda ner | Visa Stäng |
|