The study analyzed that the IPF pipeline comprised of 97 therapeutic candidates, of which 15 are in Phase II stage of development. The lack of complete cure for IPF fuels the extensive research and development for the IPF therapeutic. Various drugs are being developed as novel and promising therapeutics for the treatment of IPF.
Insights on pipeline segments
As per the findings of research, it was found that around 9% IPF candidate target chemokine, 7% target integrin and 6% of the product candidates target G-protein couple receptor. Other targets comprising 78% of candidates of IPF pipeline include, but not limited to, autotaxin, connective tissue growth factor-associated, fibroblast growth factor, lysyl-oxidase like protein 2 and tissue growth factor beta. Around 55% pipeline therapeutic candidates of IPF are being developed to be administered by oral route, 20% by inhalation route, 12% by intravenous route and 8% by subcutaneous route.
Phase III stage of development consist of only one IPF drug
Thrombomodulin Alfa (ART-123) is under Phase III stage of development by Asahi Kasei Pharma Corporation for the treatment of IPF. It is already marketed in Japan under the name of Recomodulin for the treatment of disseminated intravascular coagulation. Thrombomodulin Alfa is a soluble recombinant human thrombomodulin and inhibits the coagulation process by accelerating the activation of protein C by thrombin. The drug candidate is administered by intravenous route.
Phase II stage of development is crowded with number of promising drugs
There are total 15 drug candidates in Phase II stage of development for the treatment of IPF. GLPG1690 is under Phase II stage of development by Galapagos NV for the treatment of IPF. The drug candidate targets lysophosphatidic acid 1 (LPA1) receptor also known as autotaxin and inhibits its action. The company plans to disclose the Phase II topline results for IPF in the first half of 2017. In February 2015, Galapagos NV released the Phase I study results for GLPG1690 (NCT02179502). GLPG1690 proved to be safe and well-tolerated over a wide dose range in healthy volunteers. The drug candidate showed favorable pharmacokinetic and pharmacodynamic profile. In this trial, GLPG1690 demonstrated the ability to reduce plasma lipid lysophosphatidic acid (LPA) levels on a sustained basis, implying ATX engagement.
More than 10 drug candidates got Orphan Drug Designation (ODD)
U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) granted ODD to more than 10 drugs. As per the FDA, its Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. Tipelukast, also known as MN-001, is under Phase II stage of development by MediciNova, Inc. for the treatment of IPF. The drug was granted ODD for the treatment of IPF, which will provide MediciNova with seven years of marketing exclusivity if it is approved for IPF. Some of the key players developing drugs candidates for the treatment of IPF are Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Global Blood Therapeutics, Inc., Asahi Kasei Corporation, Beijing Tide Pharmaceutical Co., Limited, FibroGen, Inc., Chong Kun Dang Pharmaceutical Corp., Galapagos NV, Kadmon Holdings, Inc., MediciNova, Inc., and Promedior, Inc.
News Courtesy: P&S Market Research