PILA PHARMA AB, announces ink of agreement with pre-clinical service provider ERBC
PILA PHARMA AB (publ) announces that an agreement has been signed with the company ERBC, regarding the conduct of PILA PHARMA's upcoming preclinical safety assessment studies. ERBC is a certified pre-clinical service provider, based in France and Italy.
PILA PHARMA is, as previously announced, preparing a clinical phase 2b study of the anti-diabetic drug candidate XEN-D0501. Previously, XEN-D0501 has been evaluated in both preclinical safety assessment studies and in human clinical trials of up to 1 month chronic dosing with very good safety results, suggesting the molecule to be very well tolerated in several species. The scheduled preclinical studies to be conducted at ERBC are planned to confirm the safety of XEN-D0501 prior to the initiation of planned 3-month duration phase 2b and is a regulatory requirement.
"After evaluating a set of potential pre-clinical service providers, we have decided on ERBC as our partner of choice", says Lars B. Rasmussen, COO at PILA PHARMA.
CEO Dorte X. Gram further comments: "I am very pleased that we have achieved yet another milestone in our development plan, and I look forward to getting these important studies executed."
The preclinical safety studies at ERBC are planned to start in 2022. The XEN-D0501 study material, (non-GMP API) to be used in these studies, is currently being manufactured by Almac Sciences Ltd, under a previously announced agreement.
This information is such information that PILA PHARMA AB is obliged to publish in accordance with the EU Market Abuse Regulation. The information was submitted for publication on November 26, 2021 at 08:00 CET.
Dorte X. Gram, CEO
M: +46 (0)73 903 6969
E: [email protected]
About PILA PHARMA
PILA PHARMA is a Swedish biotech company in the diabetes segment based in Malmö. The aim of the company is to develop a novel and superior tablet-based treatment for type 2 diabetes. The company owns both use patents for treating diabetes and obesity with TRPV1 antagonists, and the intellectual property rights for the mid stage clinical development candidate XEN-D0501.
About XEN-D0501 and TRPV1 antagonists
XEN-D0501 is a highly selective and very potent small molecule TRPV1 antagonist, previously in development by Bayer Healthcare and Xention/Ario Pharma. The TRPV1 target (also called the "chili-receptor") has demonstrated applications across pain and inflammatory diseases and potentially plays a role in diabetes as well. XEN-D0501 was acquired by PILA PHARMA in March 2016, due to its very good safety and tolerability as compared to other clinical TRPV1-antagonist development candidates. TRPV1 antagonists as a drug-class has previously been associated with severe adverse events as fever (hyperthermia). The maximum tolerable dose in non-diabetic individuals has previously been determined to be 4 milligrams twice daily, a dose level with good safety but no effect in non-diabetic patients with either overactive bladder disease or chronic cough. In November 2018, PILA PHARMA reported the completion of its first clinical trial, PP-CT01, demonstrating good safety of XEN-D0501 at single doses up to 8 milligrams when administered to people with type 2 diabetes. The most recent study results were announced in September 2020. The study (PP-CT02) demonstrated that multiple doses of XEN-D0501 (4 mg twice daily for 28 days) were likewise safe and well-tolerated by people with type 2 diabetes and also - with statistical significance versus placebo - that XEN-D0501 enhances the endogenous insulin response to oral glucose, thus demonstrating proof of principle.
Diabetes is a world-wide pandemic with a staggering prevalence of 537 million diabetics. Approximately 90 % of all diabetics suffer from type 2 diabetes, whilst approximately 10% suffers from type 1 diabetes. The disease can lead to cardiovascular disease resulting in reduction of quality of life for the patient, increased risk of death and high health care expenses. Despite recent therapeutic advances, large and growing unmet needs exist both from an efficacy, safety, adherence, accessibility, and affordability perspective.
Based in Baugy (France) and Roma (Italy), ERBC provides all services from preclinical proof-of-concept to market of any type of drug candidate or chemical compound. Each project is managed by a study director, relying on a multi-disciplinary team of experts, notably in general pharmacology, cardiology, electrophysiology and pathophysiology, also benefiting from a world class academic and private network. ERBC is deeply engaged in animal ethics and welfare. ERBC supports the Basel Declaration, respects the 3Rs concept and continually improves its tools and procedures to maximize the balance between the benefit for health and the animal well-being. Read more about ERBC at www.erbc-group.com.
Pila Pharma AB (publ) meddelar att US Food and Drug Administration, FDA, har beviljat Orphan Drug Designation (särläkemedelsstatus) för utvecklingskandidaten XEN-D0501 som behandling av erytromelalgi, en sällsynt sjukdom som orsakar episoder av brännande smärta och rodnad på grund av neurogen inflammation.
Pila Pharma AB (publ) announces that the US Food and Drug Administration, FDA, has granted Orphan Drug Designation (ODD) of the development candidate XEN-D0501 for treatment of erythromelalgia, a rare disease that causes episodes of burning pain and redness due to neurogenic inflammation.
Pila Pharma AB (publ) meddelar att VD Dorte X. Gram under torsdagen den 30 juni köpt 12 700 aktier i bolaget.
Pila Pharma AB (publ) announces that CEO Dorte X. Gram on Thursday, June 30, bought 12,700 shares in the company.
Pila Pharma AB (publ) meddelar att de prekliniska toxikologiska tremånadersstudierna av den aktiva substansen XEN-D0501 har inletts.
Pila Pharma AB (publ) announces that the preclinical toxicological three-month studies of the active substance XEN-D0501 has begun.
Pila Pharma AB (publ) höll på tisdagen den 7 juni årsstämma i bolagets lokaler på Västergatan 1 i Malmö. Aktieägare kunde även utöva sin rösträtt per post. Följande huvudsakliga beslut fattades:
Aktieägarna i PILA PHARMA AB, org.nr 556966-4831 ("PILA PHARMA" eller "Bolaget"), kallas härmed till årsstämma tisdagen den 7 juni 2022 kl. 11.00 på Västergatan 1 i Malmö. Registrering till stämman börjar kl. 10.30.
PILA PHARMA AB (publ) (FN STO: PILA) publicerar i dag bolagets delårsrapport för perioden januari - mars 2022 som finns att ta del av på bolagets hemsida: https://pilapharma.com/investors/finansiell-information/
PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company's interim report for the period January - March 2021. The report can be found on the Company's website: https://pilapharma.com/investors/finansiell-information/
Pila Pharma AB (PILA) tillkännager i dag att det studieläkemedel (non-GMP API) som ska användas vid tremånadres prekliniska studier har erhållit ett analyscertifikat och därmed är klart att använda.
Pila Pharma AB (PILA) today announces that the study material (non-GMP API) to be used in three-month preclinical studies has received a certificate of analysis and is thus ready to use.
Pila Pharma AB meddelar att bolaget har ansökt om Orphan Drug Designation (särläkemedelsstatus) vid U.S. Food and Drug Administration, FDA, för utvecklingskandidaten XEN-D0501. Syftet är att ta fram en behandling av en sjukdom förknippad med smärta på grund av neurogen inflammation.
Pila Pharma AB announces that the company has submitted a request for an Orphan Drug Designation to the U.S. Food and Drug Administration (FDA) for the company's development candidate XEN-D0501. The aim is to develop a novel treatment of a rare disease associated with pain due to neurogenic inflammation.
Pila Pharma AB (publ) meddelar att årsredovisningen nu finns tillgänglig på bolagets hemsida, https://pilapharma.com/investors/finansiell-information, samt som bilaga till detta pressmeddelande.
Pila Pharma AB (publ) announces that the annual report now is available on the company's homepage, https://pilapharma.com/investors/finansiell-information, and as an attachment to this press release.
Pila Pharma AB (publ) meddelar att årsredovisningen för 2021, som skulle publiceras den 22 mars 2022, är försenad och istället kommer att publiceras den 23 mars 2022.
Pila Pharma AB (publ) announces that the annual report for 2021, which was to be published on March 22, 2022, is delayed and will instead be published on March 23, 2022.
PILA PHARMA AB