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Vertex's (VRTX) Pain Candidate Meets Goal in Two Studies
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Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced positive data from two phase II proof-of-concept (“POC”) studies evaluating its oral NaV1.8 inhibitor candidate, VX-548, for the treatment of acute pain following abdominoplasty surgery or bunionectomy surgery.
Data from the studies showed that treatment with an initial 100 mg dose of VX-548 followed by a 50 mg dose every 12 hours led to a rapid, statistically significant and clinically meaningful improvement in the time-weighted Sum of Pain Intensity Difference over 48 hours as compared to placebo – the primary endpoint.
Treatment with VX-548 was generally well tolerated in both studies.
Based on the success of the two POC studies and following discussions with health regulators, Vertex plans to advance VX-548 into pivotal development in the second half of 2022.
Per the company, VX-548 has the potential to be a first-in-class non-opioid treatment for acute pain. Both the above-mentioned studies included a hydrocodone bitartrate/acetaminophen reference arm to support the evaluation of the VX-548 treatment effect.
Shares of Vertex have rallied 18.8% so far this year against the industry’s decline of 12%.
Image Source: Zacks Investment Research
NaV1.8 is a genetically validated novel target to treat pain. Vertex is evaluating NaV1.8 inhibitors with the goal of preventing pain signals traveling from sensory nerves to the central nervous system.
VX-548 is part of Vertex’s rapidly progressing non-cystic fibrosis (“CF”) pipeline. While Vertex’s main focus remains on the development and strengthening of its CF franchise, the company also has a rapidly advancing portfolio in diseases beyond CF. These areas, other than pain, include APOL1-mediated kidney diseases, sickle cell disease, beta-thalassemia and cell therapy for type I diabetes.
In March 2022, Vertex announced that it is moving VX-147, its first oral small molecule medicine for APOL1-mediated kidney disease, into pivotal development.
A pivotal phase III study on VX-147, targeting a broad patient population with proteinuric kidney disease mediated by two mutations in the APOL1 gene (“AMKD”), is expected to begin shortly. The study will evaluate what impact VX-147, in addition to standard of care, has on kidney function and proteinuria in people with AMKD.
Vertex is co-developing a gene-editing treatment, CTX001, in partnership with CRISPR Therapeutics (CRSP - Free Report) , in two devastating diseases — sickle cell disease and thalassemia. Phase I/II studies of CTX001 in adult transfusion-dependent b-thalassemia in Europe and sickle cell disease in the United States are ongoing. Preliminary safety and efficacy data from the studies were positive.
Vertex and CRISPR Therapeutics plan to file regulatory applications for CTX001 for both indications by 2022 end.
Vertex is evaluating VX-880 in a phase I/II study for the treatment of type I diabetes.
Zacks Rank & Other Stocks to Consider
Vertex currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector are Athersys, Inc. , and Kaleido Biosciences, Inc. , both sporting the same Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Athersys’ earnings estimates have been revised 21.7% upward for 2022 over the past 60 days.
Earnings of ATHX surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Kaleido Biosciences’ loss per share estimates have narrowed 23% for 2022 over the past 60 days.
Earnings of KLDO surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion.
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Vertex's (VRTX) Pain Candidate Meets Goal in Two Studies
Vertex Pharmaceuticals Incorporated (VRTX - Free Report) announced positive data from two phase II proof-of-concept (“POC”) studies evaluating its oral NaV1.8 inhibitor candidate, VX-548, for the treatment of acute pain following abdominoplasty surgery or bunionectomy surgery.
Data from the studies showed that treatment with an initial 100 mg dose of VX-548 followed by a 50 mg dose every 12 hours led to a rapid, statistically significant and clinically meaningful improvement in the time-weighted Sum of Pain Intensity Difference over 48 hours as compared to placebo – the primary endpoint.
Treatment with VX-548 was generally well tolerated in both studies.
Based on the success of the two POC studies and following discussions with health regulators, Vertex plans to advance VX-548 into pivotal development in the second half of 2022.
Per the company, VX-548 has the potential to be a first-in-class non-opioid treatment for acute pain. Both the above-mentioned studies included a hydrocodone bitartrate/acetaminophen reference arm to support the evaluation of the VX-548 treatment effect.
Shares of Vertex have rallied 18.8% so far this year against the industry’s decline of 12%.
Image Source: Zacks Investment Research
NaV1.8 is a genetically validated novel target to treat pain. Vertex is evaluating NaV1.8 inhibitors with the goal of preventing pain signals traveling from sensory nerves to the central nervous system.
VX-548 is part of Vertex’s rapidly progressing non-cystic fibrosis (“CF”) pipeline. While Vertex’s main focus remains on the development and strengthening of its CF franchise, the company also has a rapidly advancing portfolio in diseases beyond CF. These areas, other than pain, include APOL1-mediated kidney diseases, sickle cell disease, beta-thalassemia and cell therapy for type I diabetes.
In March 2022, Vertex announced that it is moving VX-147, its first oral small molecule medicine for APOL1-mediated kidney disease, into pivotal development.
A pivotal phase III study on VX-147, targeting a broad patient population with proteinuric kidney disease mediated by two mutations in the APOL1 gene (“AMKD”), is expected to begin shortly. The study will evaluate what impact VX-147, in addition to standard of care, has on kidney function and proteinuria in people with AMKD.
Vertex is co-developing a gene-editing treatment, CTX001, in partnership with CRISPR Therapeutics (CRSP - Free Report) , in two devastating diseases — sickle cell disease and thalassemia. Phase I/II studies of CTX001 in adult transfusion-dependent b-thalassemia in Europe and sickle cell disease in the United States are ongoing. Preliminary safety and efficacy data from the studies were positive.
Vertex and CRISPR Therapeutics plan to file regulatory applications for CTX001 for both indications by 2022 end.
Vertex is evaluating VX-880 in a phase I/II study for the treatment of type I diabetes.
Zacks Rank & Other Stocks to Consider
Vertex currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the biotech sector are Athersys, Inc. , and Kaleido Biosciences, Inc. , both sporting the same Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Athersys’ earnings estimates have been revised 21.7% upward for 2022 over the past 60 days.
Earnings of ATHX surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Kaleido Biosciences’ loss per share estimates have narrowed 23% for 2022 over the past 60 days.
Earnings of KLDO surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion.