Summit Therapeutics to raise funds for Duchenne and C diff drugs
UK biotech firm Summit Therapeutics is preparing a US share offer to raise funding for its research programmes.
The Oxford-based company is already listed on London’s AIM market, but will now also join the NASDAQ, where it hopes to raise around $33 million via an initial public offering next week.
Its two lead candidates are of two mid-stage drugs, SMT C1100 for Duchenne Muscular Dystrophy (DMD) and SMT19969 for C difficile infections.
Both drugs are in areas of high unmet medical need, but face competition from other firms now investing in these areas.
SMT C1100 is the novel class of utrophin modulators, and received regulatory approval for a Phase 1b trial in DMD patients.
There are currently no effective treatments for DMD on the market, however a breakthrough treatment from Prosensa looks close to receiving approval.
The Netherlands-based biotech (recently acquired by BioMarin) is in the process of filing its first-in-class exon-skipping treatment drisapersen with the FDA. This will quickly raise expectations about what can be achieved in DMD, putting pressure on Summit’s drug to demonstrate efficacy.
The promise of SMT C1100 and utrophin modulators is that they could treat all patients with DMD, whereas Prosensa’s exon-skipping drisapersen can only treat 13-15% of the patient population.
SMT C1100 would also have the advantage of being an oral drug, rather than an injectable delivery required for Prosensa’s drug.
Summit’s other drug, novel antibiotic SMT19969, is currently in a Phase 2 proof of concept trial being conducted in North America.
In July, the FDA designated SMT19969 for the treatment of CDI as a Qualified Infectious Disease Product (QIDP), a special status which confers Priority Review and Fast Track status and a five-year extension of market exclusivity if approved.
Increasing concern about the rise of antimicrobial resistance (AMR) to existing antibiotics has helped revive interest in drug development, with companies such as Cubist gaining approval for new treatments in 2014.
Summit has also set up a new US research base in Cambridge, Massachusetts last year, to help strengthen its ties with academic and commercial R&D leaders in its two therapy areas.
The company recorded a loss for first nine months of 2014 of £8.3 million, up from £3.8 million in the same period the year before, and had cash reserves of £15 million.
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