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Intellia (NTLA) Up on Positive Data Updates From HAE Study
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Intellia Therapeutics (NTLA - Free Report) updated interim data from the phase I portion of phase I/II study of NTLA-2002 to treat hereditary angioedema (HAE). The company’s shares rose almost 7% in pre-market today.
NTLA presented the data at the European Academy of Allergy and Clinical Immunology Hybrid Congress 2023.
With a cut-off date of Feb 17, 2023, the interim data indicated that patients suffering from HAE experienced a reduction in attacks following the administration of a single dose of NTLA-2002. HAE is a rare genetic disorder characterized by recurring attacks of severe swelling, which can be painful and even life threatening.
During the study, patients received single doses of NTLA-2002 at three different doses — 25 mg, 50 mg and 75 mg. The study measured HAE attack rates and plasma kallikrein protein levels for each patient. The initial analysis demonstrated that the three earliest-dosed patients have been attack-free for approximately a year or even longer, highlighting the therapy's potential for a long-lasting efficacy.
An impressive average decrease of 95% in monthly attack rates was observed in all 10 patients after receiving a single dose. Each dose level exhibited significant reductions in HAE attack rates, and the absence of attacks has been consistently maintained over an extended period.
Moreover, all nine patients who achieved a reduction of more than 60% in plasma kallikrein levels have remained completely free from HAE attacks since the 16-week observation period.
Only one patient in the 25-mg dose group did not reach the targeted reduction in kallikrein but reported a single mild attack following an unrelated sports injury. This incident, however, did not require medical intervention, and the patient has not encountered any subsequent HAE attacks.
Additionally, six out of 10 patients who were previously on long-term HAE prophylaxis medications before receiving NTLA-2002 were able to discontinue their prophylactic therapy without experiencing subsequent attacks.
The safety profile of NTLA-2002 was also encouraging. At all three dose levels, the therapy was well tolerated. NTLA-2002 is the first single-dose CRISPR therapy designed to prevent angioedema attacks in HAE patients to enter clinical studies.
Shares of Intellia have risen 23.9% year to date against the industry’s 7.8% decline.
Image Source: Zacks Investment Research
Based on the interim finding, management believes that NTLA-2002 could be a “functional cure” for HAE patients.
In March 2023, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to NTLA-2002 for the treatment of HAE. The RMAT designation increases the opportunity to meet FDA officials. It also facilitates accelerated approval of a candidate based on surrogate or intermediate endpoints.
Intellia is dosing patients in a phase II portion of phase I/II study for NTLA-2002 and expects to complete patient enrollment in the second half of this year.
Loss per share estimates for Akero Therapeutics have narrowed from $3.46 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have declined 4.2% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimates for ADMA Biologics have narrowed from 19 cents to 9 cents for 2023 in the past 90 days. In the year so far, shares of ADMA Biologics have declined 1.5%.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
Loss per share estimates for Omega Therapeutics have narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have risen 37.8% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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Intellia (NTLA) Up on Positive Data Updates From HAE Study
Intellia Therapeutics (NTLA - Free Report) updated interim data from the phase I portion of phase I/II study of NTLA-2002 to treat hereditary angioedema (HAE). The company’s shares rose almost 7% in pre-market today.
NTLA presented the data at the European Academy of Allergy and Clinical Immunology Hybrid Congress 2023.
With a cut-off date of Feb 17, 2023, the interim data indicated that patients suffering from HAE experienced a reduction in attacks following the administration of a single dose of NTLA-2002. HAE is a rare genetic disorder characterized by recurring attacks of severe swelling, which can be painful and even life threatening.
During the study, patients received single doses of NTLA-2002 at three different doses — 25 mg, 50 mg and 75 mg. The study measured HAE attack rates and plasma kallikrein protein levels for each patient. The initial analysis demonstrated that the three earliest-dosed patients have been attack-free for approximately a year or even longer, highlighting the therapy's potential for a long-lasting efficacy.
An impressive average decrease of 95% in monthly attack rates was observed in all 10 patients after receiving a single dose. Each dose level exhibited significant reductions in HAE attack rates, and the absence of attacks has been consistently maintained over an extended period.
Moreover, all nine patients who achieved a reduction of more than 60% in plasma kallikrein levels have remained completely free from HAE attacks since the 16-week observation period.
Only one patient in the 25-mg dose group did not reach the targeted reduction in kallikrein but reported a single mild attack following an unrelated sports injury. This incident, however, did not require medical intervention, and the patient has not encountered any subsequent HAE attacks.
Additionally, six out of 10 patients who were previously on long-term HAE prophylaxis medications before receiving NTLA-2002 were able to discontinue their prophylactic therapy without experiencing subsequent attacks.
The safety profile of NTLA-2002 was also encouraging. At all three dose levels, the therapy was well tolerated. NTLA-2002 is the first single-dose CRISPR therapy designed to prevent angioedema attacks in HAE patients to enter clinical studies.
Shares of Intellia have risen 23.9% year to date against the industry’s 7.8% decline.
Image Source: Zacks Investment Research
Based on the interim finding, management believes that NTLA-2002 could be a “functional cure” for HAE patients.
In March 2023, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to NTLA-2002 for the treatment of HAE. The RMAT designation increases the opportunity to meet FDA officials. It also facilitates accelerated approval of a candidate based on surrogate or intermediate endpoints.
Intellia is dosing patients in a phase II portion of phase I/II study for NTLA-2002 and expects to complete patient enrollment in the second half of this year.
Intellia Therapeutics, Inc. Price and Consensus
Intellia Therapeutics, Inc. price-consensus-chart | Intellia Therapeutics, Inc. Quote
Zacks Rank and Stocks to Consider
Intellia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics (AKRO - Free Report) , ADMA Biologics, Inc. (ADMA - Free Report) , and Omega Therapeutics (OMGA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Akero Therapeutics have narrowed from $3.46 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have declined 4.2% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimates for ADMA Biologics have narrowed from 19 cents to 9 cents for 2023 in the past 90 days. In the year so far, shares of ADMA Biologics have declined 1.5%.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
Loss per share estimates for Omega Therapeutics have narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have risen 37.8% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.