Tuesday, Roivant Sciences ( ROIV ) and Priovant Therapeutics announced results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis (NIU). 

Roivant Sciences ( ROIV ) was founded by former Republican Party presidential candidate Vivek Ramaswamy.

NIU is a group of disorders characterized by intraocular inflammation at different levels of the eye.

At week 24, 29% (5/17) of subjects in the brepocitinib 45 mg arm and 44% (4/9) of subjects in the brepocitinib 15 mg arm met Treatment Failure criteria, with lower failure rates reflecting greater treatment benefit. 

The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm. 

These observed results represent approximately twice the observed benefit as seen in the corresponding registrational study for the only approved non-steroidal therapy in NIU.

All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose-responsive. 

Of patients in the brepocitinib 45 mg arm who met the threshold for uveitic macular edema at baseline, 43% achieved resolution of macular edema by week 24. 

No patients in the brepocitinib 45 mg arm who entered the study without macular edema developed macular edema by week 24.

Safety and tolerability were consistent with prior clinical studies of brepocitinib, with no new safety or tolerability signals identified. 

Priovant intends to initiate a Phase 3 program for NIU in the second half of the calendar year 2024. 

The ongoing Phase 3 study evaluating brepocitinib in dermatomyositis is expected to fully enroll in Q3 of 2024, with data expected in the calendar year 2025.

Roivant also announced that its board of directors authorized a share repurchase program for up to $1.5 billion, including repurchasing all 71.3 million shares held by Sumitomo Pharma at $9.10 per share. 

The aggregate purchase price for the Sumitomo Pharma transaction is approximately $648.4 million and will reduce Roivant’s outstanding shares by approximately 9%.

Price Action: ROIV shares are up 5.37% at $10.99 on the last check Tuesday.