Fibrodysplasia Ossificans Progressiva: Research

(asked on 29th October 2021) - View Source

Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 22 October 2021 to Question 58780, on Fibrodysplasia Ossificans Progressiva: Research, if he will provide details of the eight studies into fibrodysplasia ossificans progressive (FOP) supported by funding through the National Institute for Health Research.


Answered by
Maria Caulfield Portrait
Maria Caulfield
Parliamentary Under Secretary of State (Department for Business and Trade) (Minister for Women)
This question was answered on 29th November 2021

The titles of seven of the studies supported by the National Institute for Health Research on fibrodysplasia ossificans progressiva (FOP) are as follows:

- Saracatinib Trial TO Prevent FOP (Fibrodysplasia Ossificans Progressiva);

- Isolation and Generation of Blood-derived Progenitor Cells from Patients with Cardiovascular Disease and TGF-beta Superfamily-related Diseases;

- A Phase 2 Randomized, Double Blind, Placebo Controlled Efficacy and Safety Study of a RARĪ³-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flareups in Subjects with Fibrodysplasia Ossificans Progressiva;

- A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RARĪ³-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva;

- A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva;

- A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva; and

- A Phase 2, two-part, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of two dosage regimens of oral IPN60130 for the treatment of fibrodysplasia ossificans progressiva in male and female participants five years of age and older.

We are unable to provide details of the remaining study as this information is commercially sensitive.

Reticulating Splines