By Mark Terry
Seattle-based Impel NeuroPharma closed on a Series D financing totaling $67.5 million. It was co-led by KKR and Northwest Venture Partners. Existing investors Vivo Capital, 5AM Ventures and venBio Partners also participated.
The money will be used to speed the clinical development of its existing portfolio for central nervous system (CNS) disorders. It has three programs for its Precision Olfactory Delivery (POD) device technology. INP104 is in a Phase III clinical trial for acute migraine headache. INP103 is in a Phase II clinical trial for the reversal of OFF episodes in Parkinson’s disease. INP105 is in a Phase I clinical trial for the treatment of acute agitation in bipolar I and schizophrenia disorders.
The company is expected to release initial data from the Phase III trial of INP104 in late 2019.
Also as part of the financing, Robert Mittendorff, partner at Northwest, and Ali Satvat, member at KKR, will join the Impel board of directors.
“We are delighted to have the support of this exceptional group of both new and existing investors,” stated Jon Congleton, Impel’s chief executive officer. “Dr. Mittendorff and Mr. Satvat will be tremendous assets as new members of Impel’s board of directors and we believe that this investment is a testament to the strength of our POD technology, our clinical programs and our management team.”
The POD technology is a nasal drug delivery platform designed to deliver drugs in a consistent and predictable manner, what you could call a nose-to-brain delivery system. It is designed to get around the barriers that oral medications face in getting past the blood-brain barrier. Not only does it have the potential of decreasing side effects of many CNS drugs, such as constipation, but it should speed the delivery of the drug.
The company was launched in 2008 by John Hoekman, co-founder and chief scientific officer. In 2008, Hoekman was a 28-year-old PhD student at the University of Washington.
Although previous nasal delivery approaches have failed, Hoekman’s approach uses a liquid HFA propellant, which is converted to gas and pushes the drug dose out of the device’s nozzle. This results in a narrow precision stream of the drug, driven by the HFA gas, deep into the nasal cavity.
“We are thrilled to contribute to the development of innovative solutions that may enhance the lives of patients with CNS disorders,” stated Satvat. “Impel’s proprietary, novel platform has the potential to transform intranasal drug delivery, significantly improving the range of treatment options for people living with acute migraine, acute agitation and Parkinson’s disease.”
On August 29, Impel announced it had dosed the first patient in its Phase I trial of INP105. The SNAP 101 trial is designed to evaluate the safety, tolerability and pharmacokinetic/pharmacodynamic profile of INP105 at three doses compared to two doses of Zyprexa intramuscular (5 mg and 10 mg) and orally disintegrating Zyprexa Zydis (10 mg) in 36 healthy volunteers.
On August 22, Impel announced the first patient had been dosed in its Phase III trial of INP104. The STOP 301 trial is evaluating the safety and tolerability of long-term, intermittent use of INP104 for 24-week and 52-week data points, as well as efficacy data of the drug and device in migraine headache.
“We are very pleased with the speed of recruitment to the STOP-301 study and anticipate that this reflects the level of unmet need in the market and enthusiasm for novel treatments,” Congleton said at the time. “We believe that INP104 stands to provide a gold-standard migraine therapy in a device that offers rapid and optimized bioavailability.”