Synlogic SYBX announced that it has initiated the phase I study of SYNB1934, an investigational synthetic biotic candidate for the treatment of phenylketonuria (“PKU”). The candidate will be administered orally, and is being developed for all age groups as well as genotypes.
SYNB1934 is an evolved strain of SYNB1618, which is currently in phase II study. The data from this study is anticipated in second-half 2021.
PKU is marked by an inability to break down phenylalanine (“Phe”), an amino acid found in many foods. High Phe levels can result in serious neurological and neuropsychological problems affecting a person’s actions. Both SYNB1618 and SYNB1934 are being evaluated to lower Phe levels through the consumption of Phe in the gastrointestinal tract, and enable consumption of more natural dietary protein.
We note that while both the candidates offer the same potential treatment, data from preclinical in vivo and in vitro studies indicates that the evolved strain has demonstrated greater than two-fold improvement in breaking down Phe levels based on the production of Phe metabolites.
Shares of Synlogic have rallied 60.2% so far this year against the industry’s 4.1% decline.
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The phase I multiple ascending dose study of SYNB1934 will evaluate the drug’s Phe consumption activity and head-to-head comparison with SNYB1618 in healthy volunteers using biomarkers of Phe consumption. Synlogic plans to use the data from the ongoing studies to select either one of the candidates for late-stage development.
Since PKU is an inherited metabolic disease that manifests at birth, many countries screen their infants at birth for an early diagnosis and treatment to avoid intellectual disability as well as other complications. A success in the development of the synthetic biotic candidates will boost the company’s prospects.
Zacks Rank & Other Stocks to Consider
Synlogic currently carries a Zacks Rank #2 (Buy).
Other favorable stocks in the healthcare sector include Acadia Pharmaceuticals ACAD, Biomarin Pharmaceutical BMRN and Exact Sciences EXAS. While Biomarin and Exact Sciences currently carry a Zacks Rank #1 (Strong Buy), Acadia holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acadia’s loss estimates for 2022 have narrowed from $0.83 to $0.81 per share in the past 30 days.
Biomarin’s earnings estimates for 2022 have increased from $2.33 to $2.35 per share in the past 30 days.
Exact Sciences’ loss estimates for 2021 have narrowed from $2.65 to $2.51 per share in the past 30 days.
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