Healthcare Business

An Upcoming Drug May Emerge as the Winner in the War on Chronic Severe Gout

Selecta Biosciences Inc. (NASDAQ: SELB) is still in the hunt for treating gout. Specifically, this company is aiming to unlock the full potential of biologic therapies by mitigating unwanted immunogenicity. The company’s SEL-212 is targeting the treatment of chronic severe gout.

Gout is one of the areas that has been harder to treat. Many of the treatments on the market have been the same for decades, and many gout, acid-reducing and inflammation-reducing drugs can come with their own sets of adverse side effects.

Data were recently presented at the Pan American League of Associations for Rheumatology (PANLAR) 2018 Congress in Buenos Aires, Argentina. According to Selecta Biosciences, SEL-212 is designed to be the first non-immunogenic version of uricase. This would allow for the effective and safe administration of multiple doses with concurrent mitigation of antidrug antibodies against the pegsiticase enzyme.

The PANLAR data covered patients who received three monthly doses of SEL-212, up to 0.15 mg/kg of SVP-Rapamycin in combination with 0.2 or 0.4 mg/kg of pegsiticase. Patients also were given two monthly doses of pegsiticase alone. The company’s report said:

Approximately 75% of evaluable patients maintained serum uric acid level control below 6 mg/dl during the initial three months of therapy with concurrent mitigation of ADAs against the pegsiticase enzyme. Furthermore, 91% of patients dosed with pegsiticase alone in month four after the initial three monthly doses of SEL-212 maintained serum uric acid control demonstrating the potential of SVP technology for the induction of immune tolerance.

While a new treatment for gout will be welcome for those who suffer from it, Selecta is still some time away from generating significant revenues from SEL-212. The company is targeting a Phase 3 study in mid-2018, pending the outcome of the FDA process.

Selecta also said that roughly 25% of the patient population treated with SEL-212 in the ongoing Phase 2 trial experienced gout flares during the first month after treatment, with continued reduction of flare rates during the period of month two to month five. The company pointed out that this low rate of gout flares appears to be in contrast with higher incidence of flares that had been seen in clinical trials involving other urate-lowering therapies.

As of the end of 2017, Selecta still had $97 million in cash, and the company reiterated that its runway was fine through mid-2019. At that same time, Selecta announced at the National Cancer Institute that its SEL-403 was the company’s next clinical candidate that has entered the clinic for the treatment of patients with mesothelioma. Targeting mesothelioma, if successful, would add patients one more target in treating asbestos exposure.

Selecta’s stock dropped to $9.36 around the April 10 PANLAR presentation, but now its shares are back near $13.00. This has been a volatile stock, and investors have seen its post-2016 IPO trading come full circle. Its June 2016 IPO was 5 million shares at a price of $14.00 per share. Its 52-week range is $7.95 to $24.02.

Selecta originally had filed for an initial public offering back in 2016, and it had a fairly small underwriting syndicate due to the size of the offering. UBS and Stifel had been targeted as initial lead underwriters, and co-managers were listed as Canaccord Genuity and Needham.

On February 27, 2018, Mizuho started Selecta Biosciences with a Buy rating, and the firm issued a $30 price target. And in late 2017, Canaccord Genuity reiterated its Buy rating and raised its target price on the stock to $30 from $25.

Unfortunately, most analysts do not see revenues and full royalties starting to be paid until 2020 or 2021. Either way, a new medicine for those who suffer from chronic severe gout would be welcome.

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