Dive Brief:
- Thar Pharmaceuticals has filed an initial public offering (IPO) with the Securities and Exchange Commission (SEC) with the goal or raising $50 million, according to the August 19 filing
- The drug maker, based in Pittsburgh, plans to use the capital to continue developing its drug T121, a treatment for Complex Regional Pain Syndrome (CRPS).
- T121 is an oral formulation of the intravenous-only therapeutic zoledronic acid (ZA) that Thar says "should improve patient convenience, compliance and comfort."
Dive Insight:
Thar hopes to raise $50 million, yet even such a relatively small IPO size and price will infuse the drug maker with the lifeblood it needs to continue developing T121 in a Phase 3 clinical trial as an oral treatment for CRPS.
The Food and Drug Administration has granted orphan drug status to the candidate as well as composition-of-matter intellectual property protection until 2030. A five-year extension is pending, Thar said.
T121, which was developed using Thar’s Enhance technology, "has a very clear path from the regulatory agencies for its development," the company added in the filing.
According to Thar, the technology can "solve clinical limitations" including bioavailability, safety, efficacy and stability, which together affect the drug’s solubility — hence its new oral route of administration — as well as permeability and pharmacokinetics.
On its website, the company claims that the technology will not affect T121’s pharmacology or pharmacodynamics. As a result, the drug can be delivered orally, which "should improve patient convenience, compliance and comfort."
Moreover there are currently no FDA-approved therapies for CRPS. Physicians often use oral opioids to treat short-term pain, though the drugs generally have poor efficacy for the condition.
Likewise, spinal-cord stimulators are sometimes used but are highly invasive, expensive and only provide temporary relief. For severe pain, physicians may also use multiple sub-anesthetic infusions of ketamine — a drug used to induse and maintain anesthesia.