Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine
Alder Also Reports Positive Phase 1 Data
Supporting Quarterly Single Injection Dosing Strategy for ALD403
Alder BioPharmaceuticals (ALDR) announced positive rrsults from two clinical trials evaluating its preventive chronic migraine monoclonal antibody drug ALD403. The drugtargets calcitonin gene-related peptide (CGRP).
ALD403 acted rapidly and prevented migraine over the entire 12-week study period, meeting both primary and secondary efficacy endpoints. Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.
According to Randall C. Schatzman, Ph.D., president and chief executive officer of Alder, ALD403 Phase 2b data confirm and expand on the previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. Evaluation of ALD403 continues to exhibit immediate, significant and durable migraine prevention with infrequent quarterly dosing.
The data also support the quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection.
The Phase 2b clinical trial: A double-blind, placebo-controlled, randomized, single intravenous infusion, dose ranging study in patients with chronic migraine. Patients were randomized to receive a single intravenous infusion of 10 mg, 30 mg, 100 mg or 300 mg of ALD403 or placebo (approximately 120 patients per group).
The primary efficacy endpoint: The change in migraine days between ALD403 and placebo as determined by the 75% responder rates over a 12-week period. Endpoints will also be evaluated at week 24 (expected Q3 2016) and at week 48 (end of study).
Chronic migraine sufferers are defined as individuals who experience 15 or more headache days per month, of which at least 8 must be assessed as migraine days.
For more details and for details on Phase 1 Clinical Trial Evaluating Multiple Doses of ALD403 in Healthy Volunteers click HERE
Or, copy and paste the following link: http://investor.alderbio.com/releasedetail.cfm?ReleaseID=962238
Additional results, including future analysis of additional secondary endpoints, from both of these trials are expected to be presented at upcoming medical meetings and published in peer-reviewed medical journals.
Conference Call and Webcast
Alder hosted a conference call today at 8:30 a.m. ET discussing the clinical trial results.
A simultaneous webcast with slides will be broadcast live on the investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for 30 days.
THE DRUG
ALD403 is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide, (CGRP), for prevention of migraine.
CGRP is a small protein that initiates, mediates, transmits and heightens sensitivity to pain experienced in migraine. The drug was was discovered by Alder scientists and has been evaluated in multiple clinical trials on approximately 800 patients.
In a proof-of-concept clinical trial evaluating patients with frequent episodic migraine, ALD403 demonstrated significant prevention of migraines, including complete migraine relief (100% suppression of migraine occurrence) in 27% to 41% of patients in any given month.
Migraines were completely prevented in 16% of patients for the entire three-month study period.
According to the Company, ALD403 has a favorable emerging safety profile, demonstrating a similar level of safety to placebo, and has been well-tolerated in studies to date.
Alder initiated its late-stage clinical trial program in October 2015 with PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1 (PROMISE 1), a pivotal clinical trial evaluating patients with frequent episodic migraine.
Alder plans to initiate a second pivotal clinical trial, PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2), in patients with chronic migraine in the second half of 2016.
Also in 2016, Alder further plans to enter late-stage clinical development of a self-injected formulation of ALD403 to complement the infusion formulations evaluated in the PROMISE 1 and 2 trials.
Prohost Observations
No doubt about it, this news is positive and promising as the results demonstrate safety and efficacy in preventing the episodes of chronic migraine headache.
Alder BioPharmaceuticals, Inc. is a clinical-stage company focused on designing, developing and commercializing therapeutic antibodies for diseases of unmet needs.
ALD403 is the firm’s lead product and is currently undergoing the described above Phase 2b clinical trial for chronic migraines. The firm has also initiated a pivotal trial for the treatment of frequent episodic migraine and plans to initiate additional advanced clinical trials with the drug for frequent episodic and chronic migraines in 2016.
ALD1613 is the firm’s second product. It targets adrenocorticotropic hormone (ACTH) and is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for this year.
Clazakizumab is previously known as ALD518. This product, which is designed to block the pro-inflammatory cytokine IL-6 has completed a Phase 2b clinical trial.
Symbol: ADLR
Stock Price: $26.64. The stock rallied on the news trading UP $9.40
Market Cap.: $1.17 M
Enterprise Value: $449 M
Total Cash: $306
Revenues: N/A
The stock is now worth observing. ADLR is to be considered for investment, yet, we would prefer to wait until after profit-taking takes place following this huge rally.
ACADIA (ACAD)
The firm’s drug Nuplazid’s for the treatment of psychosis associated with Parkinson’s disease will be discussed by the FDA appointed committee tomorrow Tuesday March 29. We examined the FDA package that contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. We also read Acadia’s presented package. Our reasoning and impression are as follows:
The FDA has designated Nuplazid a breakthrough treatment and its package to the committee members mentions this designation. It also mentioned the fact that the one study presented by the firm is still acceptable and that the firm has effectively accomplished its due diligence. The FDA believes the statistically significant results, could be translated into mild efficacy if not every aspect related to the firm’s claim is not well analyzed. The agency mentioned the side effects with life-threatening possibility and the occurrence of a relatively small number of deaths. The FDA acknowledged that this fact should be dealt with while considering the severity of the disease itself, the age of the patients, the duration of the treatment, the Parkinson’s disease gold standard treatment used and whatever other circumstances that might cause side effects and deaths.
Although the negative bloggers and investors are doing whatever it takes to spray fear around the possible rejection of Nuplazid, general investors seem optimistic about the outcome of the committee’s meeting, as observed from the Acadia’s stock rallying today, gaining a little over 20%.
Prohost Speculation
Nobody knows the outcome of such discussions before they occur. And nobody can claim reading the contents of the FDA’s mind that are based on the agency’s great detailed study of every aspect of the drug and the disease.
Having said that, and after reading both, the FDA and Acadia’s packages, our feeling and judgment is leaning towards the general investors’ optimistic feelings, rather than with the short bloggers pessimistic sprayed opinion.
News & Comments
March 28, 2016
Alder Biopharmaceutical Migraine Headache Drug Passes the Test. Our Voting Regarding Acadia Drug Nuplazid Approval
Alder Reports Phase 2b Trial of ALD403 Meets Primary and Secondary Endpoints Demonstrating Migraine Prevention in Patients with Chronic Migraine
Alder Also Reports Positive Phase 1 Data
Supporting Quarterly Single Injection Dosing Strategy for ALD403
Alder BioPharmaceuticals (ALDR) announced positive rrsults from two clinical trials evaluating its preventive chronic migraine monoclonal antibody drug ALD403. The drugtargets calcitonin gene-related peptide (CGRP).
ALD403 acted rapidly and prevented migraine over the entire 12-week study period, meeting both primary and secondary efficacy endpoints. Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.
According to Randall C. Schatzman, Ph.D., president and chief executive officer of Alder, ALD403 Phase 2b data confirm and expand on the previous data demonstrating robust efficacy in migraine prevention in a severely afflicted patient group. Evaluation of ALD403 continues to exhibit immediate, significant and durable migraine prevention with infrequent quarterly dosing.
The data also support the quarterly dosing strategy via a single intravenous, subcutaneous or intramuscular injection.
The Phase 2b clinical trial: A double-blind, placebo-controlled, randomized, single intravenous infusion, dose ranging study in patients with chronic migraine. Patients were randomized to receive a single intravenous infusion of 10 mg, 30 mg, 100 mg or 300 mg of ALD403 or placebo (approximately 120 patients per group).
The primary efficacy endpoint: The change in migraine days between ALD403 and placebo as determined by the 75% responder rates over a 12-week period. Endpoints will also be evaluated at week 24 (expected Q3 2016) and at week 48 (end of study).
Chronic migraine sufferers are defined as individuals who experience 15 or more headache days per month, of which at least 8 must be assessed as migraine days.
For more details and for details on Phase 1 Clinical Trial Evaluating Multiple Doses of ALD403 in Healthy Volunteers click HERE
Or, copy and paste the following link: http://investor.alderbio.com/releasedetail.cfm?ReleaseID=962238
Additional results, including future analysis of additional secondary endpoints, from both of these trials are expected to be presented at upcoming medical meetings and published in peer-reviewed medical journals.
Conference Call and Webcast
Alder hosted a conference call today at 8:30 a.m. ET discussing the clinical trial results.
A simultaneous webcast with slides will be broadcast live on the investors section of Alder’s website at www.alderbio.com and will be available for replay following the call for 30 days.
THE DRUG
ALD403 is a genetically engineered monoclonal antibody that inhibits calcitonin gene-related peptide, (CGRP), for prevention of migraine.
CGRP is a small protein that initiates, mediates, transmits and heightens sensitivity to pain experienced in migraine. The drug was was discovered by Alder scientists and has been evaluated in multiple clinical trials on approximately 800 patients.
In a proof-of-concept clinical trial evaluating patients with frequent episodic migraine, ALD403 demonstrated significant prevention of migraines, including complete migraine relief (100% suppression of migraine occurrence) in 27% to 41% of patients in any given month.
Migraines were completely prevented in 16% of patients for the entire three-month study period.
According to the Company, ALD403 has a favorable emerging safety profile, demonstrating a similar level of safety to placebo, and has been well-tolerated in studies to date.
Alder initiated its late-stage clinical trial program in October 2015 with PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1 (PROMISE 1), a pivotal clinical trial evaluating patients with frequent episodic migraine.
Alder plans to initiate a second pivotal clinical trial, PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2), in patients with chronic migraine in the second half of 2016.
Also in 2016, Alder further plans to enter late-stage clinical development of a self-injected formulation of ALD403 to complement the infusion formulations evaluated in the PROMISE 1 and 2 trials.
Prohost Observations
No doubt about it, this news is positive and promising as the results demonstrate safety and efficacy in preventing the episodes of chronic migraine headache.
Alder BioPharmaceuticals, Inc. is a clinical-stage company focused on designing, developing and commercializing therapeutic antibodies for diseases of unmet needs.
ALD403 is the firm’s lead product and is currently undergoing the described above Phase 2b clinical trial for chronic migraines. The firm has also initiated a pivotal trial for the treatment of frequent episodic migraine and plans to initiate additional advanced clinical trials with the drug for frequent episodic and chronic migraines in 2016.
ALD1613 is the firm’s second product. It targets adrenocorticotropic hormone (ACTH) and is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Congenital Adrenal Hyperplasia or Cushing’s disease planned for this year.
Clazakizumab is previously known as ALD518. This product, which is designed to block the pro-inflammatory cytokine IL-6 has completed a Phase 2b clinical trial.
Symbol: ADLR
Stock Price: $26.64. The stock rallied on the news trading UP $9.40
Market Cap.: $1.17 M
Enterprise Value: $449 M
Total Cash: $306
Revenues: N/A
The stock is now worth observing. ADLR is to be considered for investment, yet, we would prefer to wait until after profit-taking takes place following this huge rally.
ACADIA (ACAD)
The firm’s drug Nuplazid’s for the treatment of psychosis associated with Parkinson’s disease will be discussed by the FDA appointed committee tomorrow Tuesday March 29. We examined the FDA package that contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the advisory committee. We also read Acadia’s presented package. Our reasoning and impression are as follows:
The FDA has designated Nuplazid a breakthrough treatment and its package to the committee members mentions this designation. It also mentioned the fact that the one study presented by the firm is still acceptable and that the firm has effectively accomplished its due diligence. The FDA believes the statistically significant results, could be translated into mild efficacy if not every aspect related to the firm’s claim is not well analyzed. The agency mentioned the side effects with life-threatening possibility and the occurrence of a relatively small number of deaths. The FDA acknowledged that this fact should be dealt with while considering the severity of the disease itself, the age of the patients, the duration of the treatment, the Parkinson’s disease gold standard treatment used and whatever other circumstances that might cause side effects and deaths.
Although the negative bloggers and investors are doing whatever it takes to spray fear around the possible rejection of Nuplazid, general investors seem optimistic about the outcome of the committee’s meeting, as observed from the Acadia’s stock rallying today, gaining a little over 20%.
Prohost Speculation
Nobody knows the outcome of such discussions before they occur. And nobody can claim reading the contents of the FDA’s mind that are based on the agency’s great detailed study of every aspect of the drug and the disease.
Having said that, and after reading both, the FDA and Acadia’s packages, our feeling and judgment is leaning towards the general investors’ optimistic feelings, rather than with the short bloggers pessimistic sprayed opinion.
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