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Savara Inc. SVRA announced that it has decided to discontinue the phase IIa exploratory clinical study ENCORE, which is evaluating its lead pipeline candidate Molgradex (molgramostim nebulizer solution) for the treatment of nontuberculous mycobacterial (NTM) lung infection in people living with cystic fibrosis (CF).
In March 2020, Savara stopped enrollment in the above-mentioned study
The decision to completely stop the ENCORE study was taken due to a couple of factors hindering its prospects of achieving the primary goal of evaluating the efficacy of Molgradex on NTM sputum culture conversion to negative.
Firstly, the COVID-19 pandemic affected patient recruitment and resulted in operational disruptions at the clinical site. Also, the approval of the triple-combination CFTR modulator, transformed the standard-of-care for the CF patient population, confounded the ability to evaluate the potential effect of Molgradex in this study.
Preliminary data from 12 of 14 patients enrolled in the study showed that five patients achieved a sputum culture conversion, which means at least three consecutive sputum samples are without growth of NTM. However, all these patients were taking the triple-combination CFTR modulator. In fact, nine of 14 patients were on the triple-combination CFTR modulator. Though culture conversions were observed in some patients, the company was unable to differentiate which drug was primarily responsible for the benefit.
Notably, Molgradex is also being evaluated in another phase IIa study OPTIMA for treating NTM in non-CF patients. The study was completed in March 2020. Following results from both these studies, Savara will not conduct further development activities on Molgradex for NTM.
Shares of Savara have declined 69.4% so far this year compared with the industry’s decrease of 4.8%.
We remind investors that Molgradex is currently being evaluated in a phase III study for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). This now remains the only indication for which the candidate is being developed now.
Savara’s other pipeline candidates include Apulmiq and AeroVanc.
Zacks Rank & Other Stocks to Consider
Savara currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the same sector include Aldeyra Therapeutics, Inc. ALDX, Jazz Pharmaceuticals PLC JAZZ and BioLineRx Ltd. BLRX, all carrying the same Zacks Rank as Savara at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aldeyra Therapeutics’ loss estimates have narrowed 13% for 2020 and 20.7% for 2021 over the past 60 days. The stock has gained 5.4% year to date.
Jazz Pharmaceuticals’ estimates have moved 3.7% and 0.2% north for 2020 and 2021, respectively, over the past 60 days.
BioLineRx’s loss estimates have narrowed 12.9% for 2020 and 50% for 2021 over the past 60 days.
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