Inside MoonLake’s raid on Merck KGaA’s inflammatory disease hopeful sonelokimab

Swiss biotech MoonLake Immunotherapeutics has emerged with what it hopes is one of the hottest drugs in inflammatory diseases, sonelokimab. In an interview with pharmaphorum’s news editor Richard Staines, chief operating officer Arnout Ploos van Amstel revealed how the biotech and its “mystery CEO” managed to swoop for the drug ahead of big pharma rivals.

Arnout Ploos van Amstel is no stranger to the cut-throat world of inflammatory disease drugs, a market that is worth billions and has spawned some of the biggest blockbusters ever.

His latest plan is to supplant one of the biggest drugs in that market: Novartis’ Cosentyx (secukinumab), which generated more than a billion dollars in revenues in the last quarter alone in diseases including psoriasis and ankylosing spondylitis.

It’s a drug that Ploos van Amstel helped to launch earlier in his career when he worked at Novartis – and he thinks sonelokimab could knock Cosentyx from its position as the leading drug in its class.

The mechanism of action is slightly different as sonelokimab inhibits both IL-17A and IL-17F and has an albumin binding site.

This and its smaller size – it’s a “nanobody” that is only a fraction of the size of conventional antibodies – could allow it to penetrate deeper into the skin and joints.

Shortly after the launch of MoonLake at the beginning of this month The Lancet published some tantalising phase 2b data in moderate to severe psoriasis that suggest MoonLake could be on the right course with sonelokimab.

The study is not powered to show superiority to Cosentyx but up to 57% of patients with moderate to severe psoriasis who took sonelokimab achieved clear skin (PASI 100) at week 24 and sustained responses over 52 weeks.

There was also a numerical benefit over a Cosentyx control arm and a favourable safety profile.

According to Ploos van Amstel, sonelokimab could be an “IL-17 2.0” and have a similar impact on this niche in the inflammatory diseases market that covers psoriasis and related diseases such as psoriatic arthritis (PSA), ankylosing spondylitis (AS) and hidradenitis suppurativa (HS).

He told pharmaphorum: “When we launched Cosentyx it was game changing compared with TNFs (tumour necrosis factor class drugs) and had efficacy data that was much better.

“Sonelokimab is such a big step forward again; you have something that is vastly better. If you have something that is significantly better than the previous agents you have a winner in your hands. I really believe we have something that has a lot of unique features.”

Merck KGaA had been developing the drug with partner Avillion and van Amstel’s team got in touch as soon as they heard the German pharma was considering selling it as part of a pipeline rethink.

Licensed in from Ablynx in 2013 five years before a merger with Sanofi, German Merck recognised its potential.

“There’s also a ‘mystery CEO’ that MoonLake has yet to unveil, who had the clout to get the deal across the line and begin exclusive negotiations once data had showed the drug’s potential”

 

But it doesn’t fit in with a portfolio focused on cancer, neurogenerative diseases, fertility and endocrinology.

Ploos van Amstel’s plan allows it to be developed by a team of experts in the field while allowing Merck to get a return on its investment so far.

Not only did Ploos van Amstel begin talks before big pharma rivals got wind of the development, his team was able to put forward a potentially broad development plan that could include PsA, AS and HS as well as psoriasis.

Before moving to phase 3 MoonLake will likely plan phase 2 trials in PsA, AS and HS, which are relatively poorly served by other drugs, setting up a multi-pronged attack on the market if phase 3 trials go well.

The German pharma liked the strategy despite interest from other parties, which also took a stake in MoonLake as part of the licensing deal made possible with Series A financing led by BVF Partners.

There will also be milestone payments and “industry standard” royalties payable to Merck KGaA along the way.

Ploos van Amstel said: “Because we went broader there was a very attractive plan. It is in our and in Merck’s interest that it works as they are shareholders.

“I have worked for years and years in big pharma it is not always very fast. To the credit of Merck they chose us as partners. It’s a bold move and very calculated because we form a team that is very complementary.”

There’s also a “mystery CEO” that MoonLake has yet to unveil, who had the clout to get the deal across the line and begin exclusive negotiations once data had showed the drug’s potential.

“Myself, Kristian (Reich, Moonlake’s chief scientific officer) and the ‘third person’ made Merck believe we are the right people to deal with it.”

Looking forward Ploos van Amstel says the company may decide to develop sonelokimab in all four indications in parallel in phase 3.

That may depend on funding, trial results and whether a big pharma decides to partner with MoonLake in the future to help take the drug into late-stage development and launch it.

“It’s extremely possible a pharma company may want to partner and it can have many forms. It’s totally open but what we have to focus on is gettg the phase 2 trials showing that ‘IL-17 2.0’ is the future in inflammatory diseases.”

About the author

Richard Staines is the news editor for pharmaphorum and has been covering the pharma industry since 2010. His coverage has included stories about market access, the impact of the Greek financial crisis on the healthcare system and pharma pricing in the UK. Since joining pharmaphorum he has written stories on topics including regulation, mergers and acquisitions, and the latest clinical developments. Richard also contributes to pharmaphorum’s digital magazine, DeepDive.