eprotirome (KB2115) / Karo Pharma - LARVOL DELTA

Thyroid hormones and analogues promote the acute release of platelets from megakaryocytes: from blood donor biology to the production of platelets in vitro (ISTH 2022) - "Using metabolomics and proteomics screening methods, thyroid hormones have been identified as potent mediators of platelet production. Triiodothyronine (T3) as well as thyroid hormone analogues, GC-1 (Sobetirome), KB2115 (Eprotirome) and MGL-3196 showed a significant effect on platelet production, as well as proplatelet formation in vitro in both primary derived- and iPSC derived-megakaryocytes. These platelets that are produced under the influence of thyroid hormones are functionally active, showing degranulation (P-selectin exposure) and incorporation into thrombi."

Preclinical • Immune Modulation • Inflammation

Interim Report (Karo Bio) -

eprotirome / Karo Bio; Anticipated enrollment to commence in Q3 ’11 for P3 trial; Anticipated EU filing  by the end of 2013 or in 2014

Dyslipidemia

Eprotirome in patients with familial hypercholesterolaemia (the AKKA trial): A randomised, double-blind, placebo-controlled phase 3 study (Lancet Diabetes Endocrinol) - P3, N=236; AKKA (NCT01410383); Sponsor: Karo Bio; "Mean LDL cholesterol concentrations increased by 9% (95% CI -2 to 20) in the placebo group, decreased by 12% (-28 to 4%; p=0·0677 vs placebo) in the 50 μg eprotirome group, and decreased by 22% (-32 to -13%; p=0·0045 vs placebo) in the 100 μg eprotirome group."

P3 data • Dyslipidemia

Karo Bio terminates the eprotirome program (Karo Bio) - Karo Bio has decided to discontinue the development program for eprotirome including the on-going P3 study after an animal study has demonstrated unwanted effects following long-term exposure

Preclinical data • Product discontinuation • Trial terminated • Dyslipidemia

Karo Bio: First patient included in phase III study (Businesswire) - P3, N=630; AKKA; The first patient has been included in Karo Bio's P3 trial with eprotirome; An interim analysis, which will assess preliminary efficacy of eprotirome, is planned for Q2 2012; Karo Bio's goal is to complete the study so that a registration application may be submitted in the EU during 2014

Anticipated EU filing • Anticipated P3 data • P3 initiation • Dyslipidemia