The Food and Drug Administration has thrown a lifeline to a little known and beleaguered New Jersey therapeutics company, thrusting it into the search for Covid-19 treatments.
Bellerophon Therapeutics, Inc. (BLPH) was granted FDA approval for “emergency expanded access” to its inhaled nitric oxide delivery system for treating the novel coronavirus. On news of the development, Bellerphon’s shares, which had traded at just over $3 in early February, jumped to more than $18 before settling in at $12.67. Even at its current price, the company is light years away from its all-time high of $175 five years ago.
According to Bellerophon, the FDA’s decision immediately makes the company’s delivery system available for use at high doses in ventilated Covid-19 patients, according to an article in FierceBiotech.
Inhaled nitric oxide promotes the dilation of lung and blood vessels. The treatment is used in hospitals around the world. Bellerophon has been studying its use to prevent potentially damaging high blood pressure in the lungs among patients with chronic pulmonary diseases.
The compound has also been tested as a possible treatment for a strain of SARS, the respiratory virus that was first identiified in China 17 years ago. Like Covid-19, SARS is also a type of coronavirus. Studies have shown that nitric oxide slowed down the duplication of SARS and the need for long-term ventilator support. Given the growing demand for ventilators to treat the increasing number of Covid-19 patients, the Bellerophon system could play a key role in the fight against the virus.
The system, called INOpulse, is meant to be administered to people who have been infected as outpatients. This may be critical to help limit the further spread of the virus and reduce the burden on hospitals and their intensive care units, according to Bellerophon CEO Fabian Tenenbaum.
The company has been developing three product candidates under its INOpulse platform. The system is the company’s only remaining technology. In 2015, Bellerophon’s lead product, a bioresorbable cardiac matrix for heart attack patients, failed in a phase 3 study. Two years ago, the company’s device to treat pulmonary arterial hypertension suffered the same fate.
In February, Bellerophon effected a reverse 1-15 stock split of its shares. If the INOpulse system proves to be an effective tool in the fight against Covid-19—and the other applications the company is testing—it could return Bellorophon back to the good graces of investors.
Disclosure: The author has no position in Bellerophon.
Read more here:
- Covid-19 Could Benefit Generic Drug Companies
- Pharmaceutical Companies Gain in the Fight Against Covid-19
- Pharma M&A Has Slowed to a Crawl
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