Roivant Sciences announced it has discontinued development of several assets following a pipeline reprioritization.
On the same day Roivant Sciences announced the formation of autoimmune-focused Priovant Therapeutics in collaboration with Pfizer, the company also revealed that it has discontinued development of several assets following a pipeline reprioritization.
In its fourth quarter and year-end financial announcement, Switzerland-based Roivant said it has discontinued several programs that have been under development by its various Vant subsidiaries. Roivant said the discontinuations will allow it to more fully focus its capital resources on the “potentially most valuable and meaningful opportunities for patients in our pipeline, including our programs for newly launched Priovant.”
Discontinued programs include ARU-1801, LSVT-1701, DMVT-502, DMVT-503, DMVT-504 and CVT-TCR-01. ARU-1801, an investigational gene therapy for sickle cell disease and β-thalassemia, was being developed by Aruvant Sciences. Aruvant said it was winding down the program after considering the costs to successfully bring it through all phases of clinical testing.
Dermavant is in the process of closing out the development of DMVT-502 for vitiligo and atopic dermatitis, DMVT-503 for acne and DMVT-504 for hyperhidrosis. The Roivant subsidiary said it will instead focus on the launch of VTAMA, a topical treatment of plaque psoriasis approved by the U.S. Food and Drug Administration in May. Dermavant hinted that VTAMA, the first steroid-free topical medication in its class, has the potential for blockbuster status, with annual earnings of $1 billion or more. VTAMA is also being assessed in a Phase III study in atopic dermatitis.
Cytovant, a partnership between Roivant and Hong Kong-based Sinovant Sciences, halted the development of CVT-TCR-01, the company’s lead TCR-T program. The other program culled by Roivant was the bacteriophage-encoded lysin LSVT-1701.
While the development of those assets has been terminated, Roivant said it anticipates 10 or more pivotal or pivotal-enabling trials to be ongoing by the end of 2022. Seven of those have already been initiated, the company said. Subsidiary Immunovant launched a single potentially registrational Phase III trial assessing batoclimab for the treatment of myasthenia gravis. Topline results are expected in the second half of 2024. Immunovant also plans to initiate two Phase III trials to evaluate batoclimab for the treatment of thyroid eye disease in the second half of this year.
Another subsidiary, Hemavant, has begun an open-label Phase I/II study evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndrome patients. That study has a target enrollment of 64 patients with SF3B1 mutations. Data is expected to be announced next year. In April 2022, Kinevant initiated a Phase II trial evaluating namilumab for the treatment of sarcoidosis. Topline data is expected in 2024.
In its year-end report, Roivant said it maintains $2.1 billion in cash and cash equivalents. Those funds, plus the financing it will save from terminating the development of those programs, will allow the company to maintain financial flexibility, Roivant said.
“With $2.1 billion in cash, we are fortunate to operate from a position of financial strength, with a projected cash runway of over two years, to aggressively advance our existing programs while opportunistically adding new ones in the future. We continue to focus our capital allocation on the most meaningful opportunities for patients, including newly launched Priovant, while remaining cognizant of the current external environment and prioritizing our spend to deliver the highest return for shareholders,” Roivant Chief Executive Officer Matt Gline said in a statement.
