Selecta Biosciences Inc. (NASDAQ:SELB) has announced its Q3 2020 financial results and offered its corporate updates.
COMPARE Results Show potential of ImmTOR platform
The company’s CEO and President, Carsten Brunn said that the third quarter was productive for the company as it continued to advance its clinical programs. During the quarter the company reported topline results from its Phase 2 COMPARE study of SEL-212, which showed the potential of the ImmTOR platform in combination with a highly immunogenic enzyme. The company also initiated the Phase 3 DISSOLVE program in collaboration with Sobi.
Brunn said that Selecta is looking forward to building its gene therapy programs pipeline in OTC and MMA deficiency and the second enzyme program in IgA nephropathy. Selecta’s strategy focuses on leveraging ImmTOR platform to enhance the efficacy of biologic therapies and reinstate self-tolerance in autoimmune disorders.
Selecta Commenced DISSOLVE studies
Selecta, in partnership with Sobi, started the Phase 3 clinical study, called DISSOLVE in September. The company will run the program, and Sobi will reimburse all program-related costs. The DISSOLVE clinical study comprises of 2 double-blind, controlled SEL-21 studies whereby the company will evaluate SEL-212 at two ImmTOR doses and one pegadricase dose in both studies. Every trial expects to recruit 105 patients who will be 35 per dose level and 35 for the placebo group.
The DISSOLVE I study will evaluate efficacy and safety at six months with a six month extension while DISSOLVE II will assess safety and efficacy at six-month time point without an extension. The studies’ primary endpoint will be serum uric acid levels below 6mg/dL after six months which is a will validated disease severity measure in chronic refractory gout.
In September, the company also reported Phase 2 COMPARE clinical study data in which SEL-212 dose administered once monthly was compared to pegloticase doses given biweekly. Sobi, which has SEL-212 in-licenses, assumes all development responsibility except for DISSOLVE, regulatory and marketing activities in markets outside China. Selecta will receive a potential milestone payment of $630 million on SEL-212 net sales.