Intra-Cellular Positive Data, And Other News: The Good, Bad And Ugly Of Biopharma (NASDAQ:ITCI)


Intra-Cellular stock jumps as its bipolar trial delivers positive data

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) announced positive top-line data from its Phase 3 clinical trial of its lead drug candidate lumateperone. The trial was designed to evaluate the potential of lumateperone as an adjunctive therapy to lithium or valproate for treating major depressive episodes associated with Bipolar I or Bipolar II disorder.

The Study 402 met its primary endpoint with once daily lumateperone 42 mg dosage. The endpoint was related to improvement in depression as measured by change from baseline versus placebo on the MADRS total score. The drug candidate also fulfilled the secondary endpoint on the CGI-BP-S Depression Score. Lumateperone also showed dose-related improvement at 28mg dosage but failed to achieve statistically significance.

Lumateperone showed a favorable safety profile and was found to be generally well tolerated. The most commonly reported adverse events that were noted at a rate greater than or equal to 5 percent and at least twice the rate of placebo including somnolence, dizziness, and nausea. Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies said, “Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone’s label to include a second major neuropsychiatric disorder.” Other adverse events such as restlessness and akathisia were found to be similar for both the placebo and the drug candidate.

Inter-Cellular reported that that the current data along with the previously reported positive Phase 3 monotherapy study will be used for supporting its sNDA for the drug candidate. The company’s application will seek the approval for using the drug candidate for treating bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. It is expected that the company will submit its application in late 2020 or by early 2021.

Study 402 was a global trial and was carried out in five countries including the United States. The trial involved 529 patients suffering from moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder. The patients were randomized 1:1:1 to be administered lumateperone 42 mg, 28 mg or placebo, while also being maintained on lithium or valproate as mood stabilizers.

In the intent-to-treat (ITT) study population, lumateperone 42 mg showed the least squares mean reduction from baseline at 16.9 points in comparison to 14.5 points for placebo. Lumateperone 28 mg also showed a statistically significant improvement versus placebo on the CGI-BP-S, although it was not formally tested against placebo since it did not separate on the primary endpoint.

Lumateperone acts as a potent antagonist with high binding affinity at serotonin 5-HT2A receptors. It also works as an antagonist with moderate binding affinity at postsynaptic D2 receptors and an inhibitor of the reuptake of serotonin transporter with moderate biding affinity. The drug candidate is currently being evaluated for treating a wide range of conditions including bipolar depression, depression and other neuropsychiatric and neurological disorders. In vitro studies have demonstrated that lumateperone has a nearly 60-fold greater affinity for 5-HT2A receptors compared to D2 receptors.

Medtronic moves ahead with heart valve disease trial

Medtronic plc (NYSE:MDT) announced that it has received the FDA approval for carrying out an early feasibility study of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation. The device was recently given the Breakthrough Device Designation by the FDA. This designation aims to provide patients with more timely access to required technologies.

The Intrepid transcatheter valve is the same valve which is being assessed for treating symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. Azeem Latib, M.D., co-principal investigator in the study said, “There has been much progress regarding transcatheter replacement of diseased aortic valves, but whether we can replace the tricuspid valve without open heart surgery represents a new frontier in cardiology.” The device is implanted using a transfemoral delivery catheter.

It is estimated that there are over two million patients suffering from Tricuspid regurgitation in the United States alone. Earlier this month, the company had received the FDA approval for its MiniMed 770G System for pediatric patients aged between two and six years with type 1 diabetes. The system is a hybrid closed-loop diabetes management device. It measures the glucose levels in the body every five minutes. It further regulates insulin delivery by either administering or withholding insulin.

Medtronic is one of the leading medical technology companies in the world. It has presence in more than 150 countries around the world. The company recently announced its second-quarter dividend at $0.58 per ordinary share, representing a 7 percent increase over the prior year. Medtronic has the track record of increasing its annual dividend payment for the past 43 consecutive years.

Cellectar reports data from Phase 2 CLR 131 study

Cellectar Biosciences Inc. (NASDAQ:CLRB) reported positive data from its Phase 2 study in triple-class refractory multiple myeloma patients. Triple class refractory is defined as patients refractory to immunomodulatory, proteasome inhibitors and anti-CD38 antibody drug classes. The Phase 2 CLOVER-1 study is an open-label study.

Cellectar reported that it observed clinically meaningful 40% overall response rate in the subset of refractory multiple myeloma patients deemed triple-class refractory who received a total administered dose of 60 mCi or greater. Dr. John Friend, CMO of Cellectar Biosciences said, “A 40% ORR is a clinically meaningful outcome. For reference purposes, two recently approved drugs received a 25% and 31% ORR in triple class refractory patients. We look forward to the further development of CLR 131, a first in class phospholipid radio conjugate that may provide a significant benefit to patients and treatment alternative for clinicians.”

The Phase 2 CLOVER-1 study seeks to assess the efficacy and safety of CLR 131 in select B-cell malignancies. It has completed the Part A dose-exploration portion and is now enrolling in the Part B expansion cohorts evaluating ≥ 60 mCi total body dose and 2 cycle doses. The median age of the four LPL/WM patients enrolled in the study was 70.

CLR 131 is a small-molecule Phospholipid Drug Conjugate™. It works by providing targeted delivery of iodine-131 to cancer cells. CLR 131 is Cellectar’s lead drug candidate and is being evaluated for different indications. It is in a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas while also being a part of a Phase 2 study in B-cell lymphomas. The drug candidate has been granted Fast Track Designation for both r/r multiple myeloma and r/r diffuse large B-cell lymphoma. It holds Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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