Some Sat morning IPIX homework (pre CFB watching) in follow-up to yesterday's post on OM unmet need, the market -- thought fellow Longs might want to start dreaming the B-OM dream (shorts perhaps fearing it), now closing in on topline results, prob only a few weeks away
Why, in any B-OM deal, imo, IPIX taking less on front-end (upfront) and getting more on the back-end (royalty) makes most sense... 10s, eventually maybe even 100s of millions, potentially in recurring revenue -- 8-9 digit $$$$$$$$$ to really blow lids of the pipeline... truly sweeten any possible Big Rx Takeout a few years hence.
Below some context on the OM lay-of-the-land ... highlighting current later-stage candidates. Pulled the studies from Clinical Trials Gov website, citing select other tidbits.
B-OM advantages, as I see it --- and they're substantial ones
1. Strong Interim results -- 50pt spread vs placebo in *Preventing* SOM (70% vs 22%); no safety signals (minimal absorption a la the B IBD study too... B efficacy now anchored in 3 indications... ABSSSI, UP/UPS, OM -- to that B Franchise-in-Making idea) 2. Efficacy Endpoint -- highest bar (reduction in incidence of SOM)... most others going after reduction in duration or incidence of OM (i.e., not explicitly SOM) 3. Ease of Administration -- swish and spit ... now only need to make it spearmint-y in taste 4. Manufacturing (cheap, fast) -- at least that's what I recall reading in past PRs
Other thoughts: IPIX will need to up the N= in any future pivotal Phase 3 (~200) and hopefully under Breakthrough (would speed recruitment along w ease of Admin... maybe 18 month t/a???)) and in Partnership w a Big Rx willing to front trial costs ... Most of the other OM drugs being trialed have FT but not BTD (yet) -- hoping topline approximates interim, though given huge unmet need and Brilacidin ability to prevent SOM, the active vs placebo spread could be less (say 15, 20-30 pt) and we'd still easily have a potential Best-in-Class for OM, again, as an "approvable" Drug is likely one that merely reduces duration of OM let alone prevents it
>Phase 3 (pivotal) (n=190) >IV (4 min) x2 per week >Primary Endpoint: Reduction in SOM >July 2017-March 2019 https://clinicaltrials.gov/ct2/show/record/NCT03237325 Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at the highest risk of developing severe oral mucositis (i.e., those receiving concomitant cisplatin chemotherapy of 80-100 mg/m2 every third week), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). http://www.soligenix.com/news/soligenix-initiates-pivotal-phase-3-clinical-trial-sgx942-dusquetide-treatment-oral-mucositis-head-neck-cancer-patients/
> Approval (low efficacy bar): -- 2004, only OM Drug on Mkt... based primarily on results in 212 patients -- In the primary efficacy study, the median duration of WHO grade 3 and 4 mucositis was significantly shorter (three days vs. nine days) in patients receiving palifermin. The reduction in median duration of severe mucositis reflects both a reduction in the incidence of severe mucositis (67 percent vs. 98 percent) and a shorter median duration in those who experienced severe mucositis (six days vs. nine days) > Admin (suboptimal): IV ... 3 days before chemo and 3 days after > Revenue: Kepivance took in close to ~$100m year 2009-2011... • 2009: $109.9 million • 2010: $94.8 million • 2011: $77.9 million > Pulled from Europe; SOBI no longer marketing it - had earlier in 2013 sought to look at its potential in HNC, not just HST (limited label)... no longer listed as source of Rev in SOBI filings http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2016/04/WC500204617.pdf https://globenewswire.com/news-release/2013/09/09/572015/0/en/Sobi-acquires-full-rights-for-Kineret-and-additional-clinical-data-for-Kepivance-from-Amgen.html http://www.kepivance.com
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