Benzinga | Dec 10, 2021 10:27AM EST

Sumitovant Biopharma Highlights Clinical, Regulatory And Commercial Achievements Across Portfolio Of Companies In Q2 2021

Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant (NYSE:MYOV), a publicly listed company that is majority-owned by Sumitovant, achieved significant clinical, regulatory and commercial milestones during the company's second quarter of fiscal year 2021 ending in October.

"The second quarter of 2021 was marked by progress on significant regulatory milestones. Enzyvant gained FDA approval of RETHYMIC(r) for pediatric patients with congenital athymia, a rare immune disorder. Also, majority-owned Myovant received FDA acceptance of MYFEMBREE(r)'s supplemental New Drug Application in pain associated with endometriosis," said Myrtle Potter, CEO of Sumitovant Biopharma. "In addition, Sumitovant companies also made significant clinical contributions to the scientific community, with key data presentations at prominent medical meetings which continue to underscore the therapeutic potential of our collective pipeline in a variety of therapeutic areas with high unmet needs."

Milestone Highlights

Enzyvant

On October 8, Enzyvant announced the U.S. Food and Drug Administration (FDA) approved RETHYMIC(r) (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia.

Myovant

On September 9, Myovant and its partner, Pfizer, announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE(r) (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the investigational use of the management of moderate to severe pain associated with endometriosis. The FDA set a target action date of May 6, 2022 for the sNDA under the Prescription Drug User Fee Act (PDUFA).

Additional Highlights

Myovant

On October 19, Myovant and its partner, Pfizer, presented data on relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) from clinical studies in uterine fibroids and endometriosis at the American Society for Reproductive Medicine (ASRM) 2021 Congress. The presentations included two-year efficacy and safety data in women with heavy menstrual bleeding associated with uterine fibroids and pooled safety and tolerability data.

In August, the FDA informed Myovant that the partial clinical hold for the Phase 3 SERENE study evaluating relugolix combination therapy for the prevention of pregnancy was lifted following study protocol amendments. The amended SERENE study protocol will evaluate the contraceptive efficacy of relugolix-CT in women with heavy menstrual bleeding associated with uterine fibroids or endometriosis-associated pain who are 18 to 50 years of age and at risk for pregnancy, and includes bone mineral density monitoring for patients during and after treatment. Patient screening with this updated protocol began in September 2021, with initial patients dosed in October 2021.

Urovant

On September 13, Urovant presented at the 2021 American Urologic Association (AUA) annual meeting new data from a dedicated ambulatory blood pressure study showing that vibegron 75mg in overactive bladder patients was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate. In addition to this presentation, further data presented at AUA included a review of the efficacy of vibegron in the OAB dry population from the EMPOWUR phase 3 pivotal trial. Urovant also presented data collected from a Director of Nursing population related to the impact of overactive bladder on residents and caregivers in the long-term care community. These data highlights were presented at the National Association of Directors of Nursing Administration (NADONA) and the Gerontological Advanced Practice Nurses Association (GAPNA) annual meetings in September 2021.

Altavant

On September 13, Altavant presented an e-poster at the European Respiratory Society annual congress highlighting the protocol design of the ongoing double-blind, placebo-controlled ELEVATE 2 (NCI NCT04712669) Phase 2b study of rodatristat ethyl (rodatristat) in patients with pulmonary arterial hypertension (PAH).

Enzyvant

On August 26, Enzyvant announced data from two first-ever studies revealing extreme clinical, emotional, social, and financial burdens on pediatric patients with congenital athymia and their families, and extraordinary costs of supportive care to healthcare systems. Posters of each of the studies were presented at the Clinical Immunology Society 2021 Annual Meeting.

On August 4, Enzyvant announced results from clinical trials of the Company's investigational RVT-802 (allogeneic processed thymus tissue-agdc), engineered human thymus tissue implanted in 105 pediatric patients, published in The Journal of Allergy and Clinical Immunology.

Spirovant

On October 28, Spirovant announced plans to deliver oral and poster presentations highlighting pre-clinical data for its compound, SP-101, an investigational novel recombinant adeno-associated virus (AAV) gene therapy selected for its tropism to human airway epithelia, at the 2021 North American Cystic Fibrosis Conference in November.