After several recent setbacks, Vitae Pharmaceuticals has at last got some good news with positive phase I results for its ROR inhibitor VTP-43742. The company’s share price shot up 89% yesterday, reflecting optimism over the asset, which is initially being tested in psoriasis.
But there is still a long way to go for VTP-43742, expected to be Vitae’s main growth driver after disappointments in diabetes and Alzheimer’s. The group will probably have to raise some more cash as the $69m it has on hand is not going to get it through clinical development.
Hot right now
The only other ROR inhibitor to reach phase I so far is Japan Tobacco’s JTE-151. Several others are in preclinical development, and the area has been an active one for partnerships of late, with big pharma companies like AstraZeneca keen to get involved (Therapeutic focus – Astra goes ROR fishing and hooks Orca, February 25, 2015).
The hope is that the approach can more directly target inflammatory responses in autoimmune diseases without leading to immunosuppression and the risk of infection. Inhibiting ROR is thought to reduce production of the inflammatory cytokine IL-17, which plays a key role in autoimmune disorders.
Some companies are also investigating ROR-targeting drugs in oncology – but here the pathway is activated to induce an immune response.
| Selected ROR research projects | |||
| Company | Project | Status | Therapy category |
| Japan Tobacco/Torii | JTE-151 | Phase I | Immunosuppressants |
| Vitae Pharmaceuticals | VTP-43742 | Phase I | Immunosuppressants |
| Innovimmune Biotherapeutics | INV-17 | Preclinical | Immunosuppressants |
| PheneX/J&J | ROR gamma t Program | Preclinical | Immunosuppressants |
| Arrien Pharmaceuticals | ARN-6039 | Preclinical | MS therapies |
| Orca/AstraZeneca | ROR Gamma Antagonist Program | Research project | Immunosuppressants |
| Lycera/Merck & Co | ROR Gamma t Agonist | Research project | Immunosuppressants |
| GENFIT | TGFTX1 | Research project | Immunosuppressants |
| Pfizer/Karo Bio | ROR-Gamma Project | Research project | Immunostimulants |
| Amgen/Teijin | ROR Gamma Research Program | Research project | Immunosuppressants |
Vitae seems to have decided not to partner VTP-43742, a decision Stifel analysts put down to the relative ease of showing proof of concept in psoriasis. After the latest study in healthy volunteers, which the company said showed a dose-dependent suppression of IL-17A, Vitae is now carrying out a multiple ascending dose phase I trial in healthy subjects and psoriasis patients.
Topline efficacy results are due by the end of the year. The company lists psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and “numerous orphan diseases” as other areas of interest.
Boehringer bows out
Vitae might also have been burnt by its recent collaboration experience: in July, Boehringer Ingelheim pulled out of a deal covering beta secretase (BACE) inhibitors for Alzheimer’s, “for strategic business reasons”. Before this, Boehringer had planned to start a phase I study of the companies’ candidate BI-1147560/VTP-36951 by the end of the year.
It is unclear if Vitae will pursue the project alone. BMO Capital Markets analysts rate this as “highly viable” but expect VTP-43742 to take priority.
Another Boehringer tie-up in type 2 diabetes is not progressing smoothly either, with the bigger company unhappy with topline phase II results with the 11β-hydroxysteroid dehydrogenase type 1 (11β HSD1) inhibitor BI187004/VTP-34072. Stifel analysts “don’t expect much from the remaining arm of the trial or from this programme”.
For now, Vitae looks to be going solo with its lead asset, VTP-43742 – so it could be in need of more funds sooner rather than later.
To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow @medtech_ma on Twitter
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