Destiny’s date with a partner

The UK company insists that by the end of the year a partner will have been found for its microbiome project to prevent C difficile infections.

Five companies have microbiome projects for recurrent Clostridioides difficile infection in development, and Destiny Pharma is bringing up the rear. But the UK company is relaxed about the competition – and is confident that it will find a partner before the end of the year.

The microbiome remains something of a fringe area for a biopharma, and the type of group that signs on the dotted line will help indicate whether this field is moving towards the mainstream. Neil Clark, Destiny’s chief executive, tells Evaluate Vantage that the company has had “a good level of interest” in its lead asset, NTCD-M3, which it wants to take into pivotal trials with a partner in place.

“Our strategy is very much to remain an R&D company, but you may see us doing a regional deal first, possibly in the US,” he says. “I can’t promise we will do a mega, Nestlé-style deal, but we would be happy to reach out to that sort of company.”

This is a reference to the Swiss multinational's $175m up-front deal last year for Seres’s SER-109, in the wake of impressive phase 3 data. The other notable bit of deal-making in this space involved Ferring’s 2018 acquisition of Rebiotix, although terms were undisclosed.

Preparing for pivotal

Destiny raised £11.5m ($15m) in late 2020 to buy NTCD-M3, though part of this sum was earmarked for manufacturing and preparations for phase 3. The asset was originated by Viropharma, which put the project through a successful phase 2 trial, but work was shelved when Shire bought Viropharma.

Mr Clark says NTCD-M3 will be ready to enter phase 3 by the end of the year. Destiny recently launched a £7m fund raising to finish those preparations and strengthen its balance sheet while talks progress. But a partner is needed to pay for the study, which is likely to enrol 800 subjects and take around three years. Patients will be recruited after the first recurrence of a C difficile infection.

This differentiates Destiny’s approach from that of other microbiome players, some of which have targeted patients much further along the recurrence pathway. Seres’s pivotal trial was conducted in patients with third and fourth recurrences, for example.

“We are coming in as a first-line therapy, and looking at lower pricing" than those going for the high-recurrence end of the market, he says.

Advantages?

Lower pricing is achievable thanks to another advantage of NTCD-M3, according to Destiny. It is derived from a single spore, rather than consortia of bacteria, making manufacturing more straightforward.

The product is based on a non-toxic strain of C difficile that, when administered, is thought to dominate the gut and prevent toxic strains proliferating. NTCD-M3 is then cleared from the body in a couple of weeks. The company puts the market potential for such a product at $500m in the US alone.

“It’s safe, it can be made at pretty low cost, and it’s very targeted. There’s a lot going on with these faecal matter or consortia approaches. By knocking out the toxic strain to allow your microbiome to recover NTCD-M3 has a very precise action,” Mr Clark says.

Early data look competitive with other microbiome approaches. The high dose that Destiny plans to take into phase 3 recorded an impressive 95% clinical response rate, though this will need confirming in a much larger trial (The year the regulators meet the microbiome, March 24, 2022).

The company also hopes to target the primary prevention market, Mr Clark says. This would involve treating patients with NTCD-M3 alongside antibiotics at the first C difficile infection, to cut the risk of recurrence.

Half a million patients a year are estimated to contract C difficile, and around a quarter of these will suffer a first recurrence. As such, primary prevention represents a very valuable proposition.  

Still, Destiny and NTCD-M3 have a long way to travel before that can be considered. First up is those partnering talks, on which all of these ambitions depend.

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