Horizon Therapeutics’ (HZNP) competitor Selecta Biosciences (SELB) reported results phase 2 of SEL-212 (pegadricase plus ImmTOR) which failed to beat Krystexxa in refractory gout patients. SEL-212 achieved a numerically better response rate at 3 and 6 months, but the results failed to reach statistical significance. SEL-212 results confirm its prior efficacy profile which is only moderately better than Krystexxa monotherapy and it does not represent an apples-to-apples comparison as SEL-212 has an unfair advantage of the addition of ImmTOR, Selecta’s immunomodulator, to pegadricase, which is the biologic candidate with the same mechanism of action as Krystexxa (pegloticase).

I believe SEL-212’s phase 2 results further solidify Krystexxa’s likely leading position in the refractory gout market given the emerging and very strong combination data of Krystexxa with approved immunomodulators (mainly methotrexate). I expect the combination to achieve much greater efficacy in the ongoing MIRROR study than SEL-212 will in its phase 3 study against placebo.

SEL-212 fails to significantly differentiate on efficacy and completely fails to differentiate on safety

Selecta’s initial pitch to investors on SEL-212 was not only that it should achieve better efficacy than Krystexxa, but that it will also have a better safety profile. In my article on Horizon last year, I noted this trial may not be relevant because of the MIRROR study where Horizon is studying Krystexxa and methotrexate combo. Not only was this trial not relevant, but it was also damaging to Selecta’s valuation given the primary endpoint failure, and it also turned out that there were no differences between SEL-212 and Krystexxa in the phase 2 study in treatment-related side effects, serious side effects, or infusion reactions.

On the efficacy side, Selecta once again resorted to per-protocol (‘PP’) assessments versus intent-to-treat (‘ITT’) assessments, though, granted, it did report ITT data as well. I will only

The COVID-19 pandemic just claimed another victim in the aerospace industry: Boeing‘s (NYSE: BA) experiment with building the 787 Dreamliner wide-body jet in two different facilities. On Thursday, the aircraft manufacturer confirmed recent news reports, saying that it will end 787 production at its main wide-body plant in Everett, Washington, by mid-2021. Its newer factory in North Charleston, South Carolina will become its sole 787 assembly plant thereafter.

This long-rumored move represents a major blow to Washington’s aerospace industry. It also suggests that Boeing does not expect 787 production to return to 2019 levels at any point in the foreseeable future.

COVID-19 forces a rethink at Boeing

Just last year, Boeing increased production of the 787 family of small and medium wide-body jets to meet high demand. During 2019 and early 2020, the company built 787s at a rate of 14 per month, up from 12 per month previously. This marked the highest production rate for a wide-body jet in history.

Even before COVID-19 devastated the global airline industry, there were signs that this production rate was unsustainable. The sharp negative impact of the pandemic on long-haul travel aggravated the growing supply demand imbalance. As a result, Boeing has sharply curtailed its 787 Dreamliner production plans over the past year. It has already reduced output from 14 per month to 10 per month, and it plans to cut back to just six per month by sometime in 2021.

A Boeing 787-9 flying over a river

Image source: Boeing.

During Boeing’s second-quarter earnings call, CEO David Calhoun said that in light of the decline in production, the company would “prudently evaluate the most efficient way to produce the 787 to include the studying the feasibility of consolidating our 787 production into one location.” That evaluation led to this week’s decision to end 787 production in Everett next