InDex Pharmaceuticals discontinues cobitolimod phase III program
· Independent Data Monitoring Committee (DMC) advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1
· More information regarding next steps will be provided once a thorough analysis of the data from Induction Study 1 has been completed
21 November, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex Pharmaceuticals”) today announces that an independent DMC has completed the planned dose selection analysis including safety review and assessment for futility in Induction Study 1 of the phase III program CONCLUDE. The DMC advises that cobitolimod is unlikely to meet the primary endpoint upon completion of Induction Study 1. The advice to stop the study was not based on safety concerns.
License agreement signed with Viatris Japan
InDex Pharmaceuticals has been granted a new patent in Europe for the commercial formulation of cobitolimod
August 2, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced that a new formulation patent for the drug candidate cobitolimod has been granted by the European Patent Office. The patent provides protection of the enema formulation of cobitolimod, that is currently under evaluation in the ongoing phase III program CONCLUDE.
InDex Pharmaceuticals announces license agreement with Viatris Japan to develop and commercialize cobitolimod in Japan
May 31, 2023 – InDex Pharmaceuticals Holding AB (publ) (“InDex”) today announced that a license agreement has been signed with Viatris Pharmaceutical Japan Inc. (“Viatris Japan”) to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. Cobitolimod is a TLR9 agonist which is being evaluated in the global phase III program CONCLUDE, as a novel treatment for moderate to severe ulcerative colitis. The agreement including milestones is worth up to USD$50m, excluding royalties.
May 24, 2023 – The annual general meeting in InDex Pharmaceuticals Holding AB (publ) was held on Wednesday 24 May 2023. The following resolutions, amongst others, were passed at the general meeting.
Positive results from pharmacokinetic study with cobitolimod
N.B. This English text is an unofficial translation of the Swedish original of the notice to attend the annual general meeting. In case of any discrepancies between the Swedish and English language versions, the Swedish version shall prevail.
April 19 2023 – Shareholders in InDex Pharmaceuticals Holding AB, reg. nr 559067-6820 (the “Company”), are hereby summoned to the Annual General Meeting on Wednesday May 24, 2023 at 17.00 (CET) at Setterwalls Advokatbyrå’s offices at Sturegatan 10 in Stockholm. Registration for the meeting commences at 16.30 (CET).
April 12, 2023 – InDex Pharmaceuticals Holding AB (publ) today publishes the Annual Report for 2022. The Annual Report is attached as a PDF and is available on the company’s website, https://www.indexpharma.com/en/financial-reports/.
PK Study fully recruited
January 27, 2023 – InDex Pharmaceuticals Holding AB (publ) today announced an update in the timing of the dose selection in the ongoing phase III study CONCLUDE with the drug candidate cobitolimod. The outcome of the dose selection is expected to be available Q4 2023. At that point in time InDex will have finalised the assessments of consequences on the overall development timeline including topline results in CONCLUDE.