PhaseBio Stock Up On Positive Data From PB2452 Phase I Study
Zacks Investment Research | Mar 18, 2019 11:57PM ET
PhaseBio Pharmaceuticals, Inc. (NASDAQ:PHAS) announced encouraging data from a phase I study evaluating its lead pipeline candidate, PB2452, as a reversal agent for the antiplatelet drug, AstraZeneca’s (NYSE:AZN) Brilinta (ticagrelor).
PhaseBio’s stock skyrocketed 67.5% following the news. Shares of the company have rallied 101.6% so far this year compared with the industry ’s growth of 15.6%.
PhaseBio is a clinical-stage biopharmaceutical company, which focuses on developing novel therapies to treat orphan diseases, especially cardiopulmonary indications.
Data from the phase I study showed that treatment with PB2452 has an immediate and sustained reversal effect on the antiplatelet effects of ticagrelor, which is prescribed to reduce risk in a cardiac event. Importantly, the benefit was observed without causing any drug-related serious adverse events.
The antiplatelet effects of Brilinta may lead to excessive bleeding, which can become life-threatening. Moreover, there is no approved drug to reverse the antiplatelet effects of Brilinta, which reflects significant growth opportunity PB2452.
Data were presented at the American College of Cardiology’s 68th Annual Scientific Session and published online in the New England Journal of Medicine paper.
Data from the early-stage study demonstrated potential to progress the development of the candidate as a treatment in emergency situations involving major bleeding and urgent surgeries.
The company is planning to initiate a phase IIa study on PB2452 in the first half of 2019, with data expected in the second half. A successful completion will be followed by initiation of phase IIb development of the candidate in 2019.
Apart from PB2452, the company has a candidate – PB1046 – which is being evaluated in a phase IIb study for the treatment of pulmonary arterial hypertension (“PAH”).
PhaseBio has an exclusive license agreement with MedImmune Limited, a subsidiary of AstraZeneca, granting PhaseBio license to develop drugs using certain patent rights owned by MedImmune. PhaseBio is liable to pay MedImmune milestone payments and royalties. However, there are no candidates in clinical-stage development under this license.
With no marketed products or collaborations, the company is dependent on government grants for funds. It has also infused funds through sale of equity, including $43 million from its initial public offering (“IPO”) in October 2018.
Investors must note that the company’s cash resources are low compared to its operating expenses in the first nine months of 2018. Without any major funding from partnerships or collaborations with other pharma companies, the company remains vulnerable to the equity market as well as borrowing options.
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