Exeporfinium Chloride

Destiny’s biggest concern right now is finding someone to help take forward XF-73. Both Destiny Pharma and Santhera Pharmaceuticals used their earnings announcements this morning to explain why a tighter clinical focus will come at the expense of one of their potential assets. In Destiny’s case, the company has decided not to extend its collaboration with SporeGen past the pre-agreed conclusion point this month. The two British biotechs had been working on a nasal spray of Bacillus bacteria that could work as a preventive treatment for COVID-19. The phase 1 candidate, dubbed SPOR-COV, has already been shown by SporeGen to provide 100% protection in preclinical models of influenza, according to Destiny’s website. But Destiny confirmed today that it would not be taking the collaboration any further as it “focus[es] resources on development of the XF platform and our other key company pipeline programs.” Destiny’s biggest concern right now is finding someone to help take forward XF-73, an antibiotic designed to prevent post-surgery infections. “The company has engaged with a number of potential partners and has received some strong and positive feedback on XF-73 nasal,” Destiny explained in the earnings release. “However, no potential licensing deal has, to date, been forthcoming that we believe would provide fair value to the company and its shareholders.” One stumbling block for potential partners are the anticipated phase 3 trial costs, as well as the general view that antibiotics have limited commercial potential, according to Destiny. To this end, the company is working to “enhance the attractiveness” of XF-73 with a new trial design that should halve the clinical costs. Destiny will also review “strategic options” for the asset, although at the moment these won’t stretch to putting the whole company up for sale. “XF-73 nasal has enormous market potential and can make a huge difference in the prevention of surgical site infections, and the reduction in the usage of antibiotics,” said CEO Chris Tovey in the release. “Whilst we will now be presenting an enhanced proposition for the product to potential partners, we also have initiated a wider review to evaluate a range of strategic options to progress the programme and to maximise value from XF-73 nasal,” Tovey added. In the case of Santhera, the writing was already on the wall for the lung disease candidate lonodelestat long before the Swiss biotech finally pulled the plug. Back in 2022, the company was already warning that available resources were being channeled to its Duchenne muscular dystrophy prospect vamorolone, leaving lonodelestat’s prospects dependent on finding fresh funding from somewhere. While the vamorolone dream became a reality when Santhera scored FDA approval last year, lonodelestat was left to languish. Focusing on the DMD drug, rebranded as Agamree, means Santhera has no time for lonodelestat. With internal development of the human neutrophil elastase inhibitor still on pause, Santhera finally confirmed in this morning’s earnings release that it is terminating work completely and will return lonodelestat to fellow Swiss biotech Spexis. “This has no further financial impact on the 2023 accounts, as an impairment was already recognized under development costs in the 2022 consolidated income statement,” Santhera pointed out.

Destiny Pharma CEO Neil Clark said a deal with Sebela Pharmaceuticals is in line with the company’s strategy to find partner companies to take their lead assets into late-stage development. Destiny Pharma could be in line for $570 million thanks to a new co-development agreement with U.S.-based Sebela Pharmaceuticals for a Clostridium difficile treatment. The two companies have agreed to work on NTCD-M3 together, with Sebela offering $1 million upfront, development milestones of $19 million and revenue-based milestones of up to $550 million, according to a Friday press release. Royalties are also included. Sebela will gain the North American rights to the treatment and lead and finance clinical development and commercialization activities in the region. U.K.-based Destiny will retain rights in Europe and the rest of the world and will complete ongoing manufacturing of clinical trial supplies for an upcoming phase 3 study. NTCD-M3 is Destiny’s lead asset under development to prevent C. difficile infection recurrence and was in-licensed in 2020. The therapy is an oral formulation of NTCD-M3 spores and protects the gut from the proliferation of toxic strains of C. difficile. A phase 3 study is expected to start in 2024, according to the release. Destiny’s CEO Neil Clark said the deal is in line with the company’s strategy to find partner companies to take their lead assets into late-stage development and reduce funding requirements. Meanwhile, Destiny used the opportunity to announce a fundraising of up to 8 million pounds sterling ($9.5 million) consisting of a placing, subscription and an open offer. The funds will help Destiny complete the required phase 3 work for NTCD-M3 as well as prep XF-73 Nasal for a phase 3 study. The treatment is being developed for preventing post-surgical staphylococcal hospital infections including MRSA.