Biotech Thar Pharmaceuticals is gunning for a $50 million IPO as it looks to launch its first pivotal trial in 2017 for an oral form of a marketed bone drug for rare forms of pain.
Its lead candidate, T121, is currently being tested for the management of pain associated with complex regional pain syndrome (a.k.a. CRPS)--a debilitating orphan condition that has no specific treatments.
It can cause severe pain to the skin around a limb or even the whole body and is estimated to affect around 80,000 people in the U.S.
T121 is being developed as an oral, non-opioid zoledronic acid molecular complex, which was given an orphan drug designation by the FDA last year for CRPS.
Zoledronic acid, a bisphosphonate, is a class of drugs known to inhibit osteoclasts, which are key cells involved in the maintenance, repair and remodeling of bone.
It is already approved in IV form for treatment of bone-related disorders, including certain cancers metastatic to bone and osteoporosis, but the biotech believes it can rework the med to help patients with CRPS.
Thar said it also plans to extend its reach outside of pain with its oral formulation into other therapy areas.
In its SEC-1 filing, Thar said of its development program: “We plan to conduct two double-blind, placebo-controlled, multisite Phase III clinical trials with approximately 150 patients each to evaluate the safety and efficacy of T121 for the treatment of pain associated with CRPS. We anticipate initiating the first pivotal clinical trial in the first quarter of 2017.”
The biotech said it holds worldwide rights for the development and commercialization of T121 with no royalty obligations to third parties.
“If we successfully complete our Phase III clinical trials and receive FDA approval, we intend to commercialize T121 in the United States through an approximately 50-person sales force targeting an estimated 4,000 pain specialists who treat patients with CRPS,” the company added.
The biotech’s current largest stockholders include Sitara Investments and Ashaway Limited. The Pittsburgh, PA-based company was founded in 2006 and plans to list on the Nasdaq under the symbol "THAR."
- check out Thar’s SEC-1 filing
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