BioXcel Therapeutics (BTI) has filed to raise $69 million through a Nasdaq IPO. BTI will spend the cash on phase 2 trials of a once-failed cancer asset and an old drug repurposed for use in Alzheimer’s and schizophrenia.
Branford, Connecticut-based BTI is a near-wholly-owned subsidiary of BioXcel, a data analytics company that made its name through deals with Alexion, Alnylam, Sanofi, Takeda, Teva and Vertex. Those leading companies teamed up with BioXcel to find new uses for existing drugs or identify indications in which their pipeline prospects are most likely to succeed. BioXcel went on to use the analytics platform to enable its own R&D ambitions, resulting in the creation of BTI last year.
The data crunching led BioXcel to conclude it can breathe new life into dexmedetomidine and talabostat. Dexmedetomidine is a well-established sedative sold by Pfizer as Precedex. BTI wants to leverage the drug’s history of use to cut a shortened path to approval of a sublingual formulation in patients with mild probable Alzheimer’s or schizophrenia. The goal is run early phase trials and a bridging BA/BE study before powering into phase 3 next year and filing for approval in 2020.
Talabostat is also backed by existing clinical data, although not all of it is positive. Point Therapeutics took the inhibitor of DPP 8/9 and FAP as far as a phase 3 trial in the 2000s, only for the placebo to outperform the drug at an interim analysis. That led to a FDA clinical hold and sent Point into a death spiral that ended with it becoming a shell company for a reverse merger.
BTI thinks it can repackage the drug for the immuno-oncology era. The plan is to pick a dose based on the existing 700-person dataset and test it in two open-label trials. One will give talabostat on its own or in combination with Keytruda to prostate cancer patients who have advanced after treatment with Xtandi or Zytiga. The second trial will test the talabostat-Keytruda cocktail in pancreatic cancer.
The results of the trials will provide insights into the effectiveness of BioXcel’s data-driven indication identification model. If the model works, BTI will have one or two promising prospects on its hands and the means to identify more rough diamonds. But the track record of the repurposing field as a whole suggests BTI could just as easily flame out.