PILA PHARMA recieves GMP certification of placebo tablets
PILA PHARMA AB (publ) ("PILA PHARMA" or "the Company") announces that the placebo tablets to be used in coming clinical studies have now been manufactured, and GMP (Good Manufacturing Practice) certified.
Placebo tablets are a key component of most clinical trials, in order to ensure a high degree of outcome reliability. Already in June 2021 the Company received GMP certification of the 4 mg tablets containing the active pharmaceutical ingredient XEN-D0501.
As a result, both the active and the placebo tablets are now ready for use in PILA PHARMA:s upcoming phase 2b clinical study in type 2 diabetes. A clinical trial application will be sumbitted as soon as the preclinical toxicology studies are completed. Currently, drug substance production for these toxicological studies are ongoing with Almac Scienes Limited.
"We're very pleased having received the GMP certification of the placebo tablets. This is another major step forward towards being able to initiate the clinical phase 2b studies in type 2 diabetes", says COO Lars B. Rasmussen and CEO Dorte X. Gram.
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 September 14, 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 463 million diabetics corresponding to approximately 8-10% of the population. 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.
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 (publ) meddelar att VD Dorte X. Gram under måndagen och tisdagen den 21 och 22 februari köpt 18 878 aktier i bolaget. Aktierna köptes till en snittkurs om 5,39 SEK.
PILA PHARMA AB (publ) announces that CEO Dorte X. Gram on Monday and Tuesday, February 21 and 22, bought 18,878 shares in the company. The shares were purchased at an average price of SEK 5.39.
Correction: Missing attached year-end report in previous pressrelease - PILA PHARMA publishes year-end report January 1 - December 31, 2021
Correction: Pressrelease 2022-02-18: In the previous pressrelease the year-end report, for 1 januar - 31 december, was not attached. This is now corrected and the report is attachted to this pressrealease.
PILA PHARMA AB (publ) (FN STO: PILA) today publishes the Company's year-end report for the period January - December 2021. The report can also be found on the Company's website: https://pilapharma.com/investors/finansiell-information/
PILA PHARMA AB (publ) (FN STO: PILA) publicerar i dag bolagets bokslutskommuniké för perioden januari - december 2021 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 year-end report for the period January - December 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 den första milstolpen avseende API-produktion har uppnåtts i sin helhet.
PILA PHARMA AB (PILA) today announces their first API manufacturing milestone has been successfully achieved.
PILA PHARMA AB