Reata Releases Update on Clinical Program, Including Phase 2 Study in PH and PAH Patients

Reata Pharmaceuticals recently provided an update on its clinical candidates and their developmental, including its Phase 2 proof-of-concept studies into bardoxolone methyl as a potential treatment for various types of pulmonary hypertension and omaveloxolone for neuromuscular diseases.

Bardoxolone methyl is being developed for patients with pulmonary arterial hypertension (PAH), or high blood pressure in the pulmonary arteries. PAH patients are known to have mitochondrial dysfunction, activated inflammatory pathways that lead to oxidative stress, increased proliferation of smooth muscle cells, and fibrosis. Bardoxolone methyl has been shown to restore mitochondrial function, resolve inflammation, and reduce oxidative stress, as well as decrease the production of enzymes linked to tissue remodeling and fibrosis.

Initial data of the Phase 2 LARIAT study (NCT02036970) was released in October 2015, revealing that bardoxolone methyl had a favorable safety profile even when combined with current PAH therapies, and improved capacities of treated PAH patients against those given placebo, as measured in the 6-minute walk test at week 16.

Importantly, bardoxolone methyl showed greatest efficacy in patients with PAH associated with connective tissue disease (CTD-PAH), who are known to respond poorly to vasodilator therapies and to have higher mortality rates, compared to those with other forms of PAH. Given that CTD-PAH is a fibrotic disease, Reata believes that bardoxolone methyl may be effective in patients with pulmonary hypertension (PH) associated with interstitial lung diseases (ILDs), and has started four Phase 2 programs to test the agent in patients whose PH was caused by four subtypes of ILD. The results are expected around mid-2017.

More information on this expansion of the LARIAT study was reported by Scleroderma News in January. LARIAT is still recruiting select PH and PAH patients at its 39 study sites across the U.S., and more information is available on the study’s clinical trials.gov website.

Reata is also running Phase 2 trials for omaveloxolone, which is similar to bardoxolone methyl but has been seen to cross the blood-brain-barrier easily. Omaveloxolone is currently being tested for patients with Friedrich’s ataxia in the MOXIe trial, and with mitochondrial myopathy in the MOTOR study. There are no approved therapies for these severe neuromuscular diseases, and Reata believes that omaveloxolone may improve mitochondrial function and chronic inflammation, which are key features of the diseases. Initial data from the MOXIe and MOTOR studies are expected in early to mid-2017.

Omaveloxolone is also being assessed in a Phase 1b/2 trial, REVEAL, in combination with checkpoint inhibitors to treat patients with metastatic melanoma. Trial results are expected in the second half of 2017.

In its update, Reata also announced financial results for the second quarter of 2016, ending June 30. The company said it incurred operating expenses of $13.8 million, of which $9.1 million were in research and development. These numbers are similar to those for the same period in 2015. Total net loss for the second quarter 2016 was $0.9 million.

On May 26, Reata began trading on the NASDAQ Global Market under the symbol RETA. Its initial public offering (IPO), which ended June 1, resulted in net proceeds of $60.9 million. As of June 30, the company had $92.4 million in cash and cash equivalents.

“The successful execution of our initial public offering this past quarter has enhanced our company’s financial position and will allow us to continue our mission of developing novel therapeutics for patients with life threatening diseases and few, or no, approved therapies,” Warren Huff, Reata’s chief executive officer and president, said in a press release.