SELB - Selecta surges ~20% as gout drug SEL-212 meets main goal in 2 phase 3 trials

2023-03-21 06:30:19 ET

Selecta Biosciences ( NASDAQ: SELB ) and Swedish Orphan Biovitrum (Sobi) ( OTCPK:BIOVF ) said SEL-212 met the main goals of two phase 3 trials to treat adult patients with chronic refractory gout.

Gout is a type of inflammatory arthritis which is very painful. Refractory gout is when the disease becomes resistant to treatment or the treatment has failed. The disorder is usually characterized by serum uric acid levels which do not fall below 6 mg/dL.

The phase 3 program called dubbed DISSOLVE included 2 studies, DISSOLVE I (the U.S. Study)  and DISSOLVE II (the Global Study). SEL-212 is a combination of Selecta's ImmTOR immune tolerance platform and a therapeutic uricase enzyme (pegadricase).

The company said DISSOLVE I met the main goal, with 56% of patients receiving monthly doses of SEL-212 at 0.15 mg/kg achieving a response (defined as achieving and maintaining a reduction in serum urate (SU) <6mg/dL for at least 80% of the time during month six, compared to 4% of patients on placebo reached the main objective.

In addition, 48% of patients on SEL-212 low dose of 0.1 mg/kg (p<0.0001) of ImmTOR showed response, meeting the goal.

DISSOLVE II also met its main goal showing a statistically significant higher response rate of SEL-212 during month 6.

About 47% and 41% of patients receiving SEL-212 at high dose and low dose of ImmTOR, respectively, compared to 12% of those on placebo reached the main objective.

The company added that statistically significant higher response rate in patients 50 years and older at the high dose was seen in the two studies.

About 65% and 47% of DISSOLVE I patients on high dose SEL-212 and the low dose of ImmTOR, respectively, compared to 5% of patients on placebo reached the main goal. Meanwhile, 48% and 45% of DISSOLVE II patients on SEL-212 high dose and low dose of ImmTOR, respectively, versus 14% of patients on placebo reached the main objective, according to the company.

Selecta noted that significant and clinically meaningful overall reduction of 69% in mean SU levels in patients on SEL-212 at 0.15mg/kg in DISSOLVE I, compared to placebo were seen. Serum urate levels were reduced by an average of 5.3 mg/dL for patients treated with both doses of SEL-212, compared to 0.3 mg/dL increase in patients receiving placebo.

"We are very pleased by the robust response rate in the high dose group of SEL-212, especially across older patients (?50 years) and the observed durability of response with no infusion reactions or new safety signals through the extension period," said Selecta's Chief Medical Officer Peter Traber.

SEL-212 was seen to have a favorable safety profile and was well-tolerated at both doses of ImmTOR, the company added.

Adverse events (AEs), including mild to moderate stomatitis, which was seen in 3.4% on low dose and 9.2% on high dose, versus 0% in placebo group. A higher number of infusion reactions at 24 hours and 1 hour after drug administration in both treatment groups, compared to placebo, were seen.

Treatment-related serious (AEs) were seen in 6 patients, including two cases of anaphylaxis and one gout flare in both the high and low dose groups.

The company noted that there was one death in the six-month extension phase of the study, which was due to motor vehicle accident unrelated to the study drug.

Selecta added that the 6-month extension part of the DISSOLVE I study showed that the majority (75%) of patients who completed 6 months of SEL-212 therapy as a responder, continued to be successfully treated through 1 year with no infusion reactions or safety signals.

"We are poised to move SEL-212 forward towards commercialization and intend to file marketing authorization applications in the U.S. in the first half of 2024," said Sobi's President and CEO Guido Oelkers.

Sobi had licensed SEL-212 from Selecta in June 2020 and is responsible for development, regulatory and commercial activities in all markets outside of China. Selecta is responsible for ImmTOR manufacturing, the companies noted. The study program was run by Selecta and funded by Sobi.

Under the agreement, Selecta is eligible to receive additional development and regulatory milestone payments totaling $65M and up to an additional $550M in commercial milestones, plus royalties on sales.

SELB +19.53% to $1.53 premarket March 21

For further details see: