The biotech sector has been in focus in the past week with key pipeline and regulatory updates. Among these, Viking Therapeutics, Inc. VKTX soared on obesity data, while Incyte INCY suffered a setback for ruxolitinib extended-release (XR) tablets.
Recap of the Week’s Most Important Stories:
Viking Soars on Study Results: Viking Therapeutics announced positive results from the phase I single ascending dose (SAD) and multiple ascending dose (MAD) clinical study of VK2735 for obesity. VK2735 is a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in development for the potential treatment of various metabolic disorders.
VK2735 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic (PK) profile in the SAD portion of the study. Following single subcutaneous doses, VK2735 demonstrated a half-life of 170 to 250 hours, a Tmax (time to reach maximum plasma concentration) ranging from 75 to 90 hours, and excellent therapeutic exposures. VK2735 demonstrated encouraging tolerability and positive signs of clinical activity in the MAD portion of the study. All cohorts receiving VK2735 showed reductions in mean body weight from baseline, ranging up to 7.8%. Cohorts receiving VK2735 also demonstrated reductions in mean body weight relative to placebo, ranging up to 6.0%
Data also showed statistically significant differences compared to placebo were maintained or improved at the day 43 follow-up time point, 21 days after the last dose of VK2735 was administered. The company believes tolerability data from this study indicate that higher doses may be achieved with longer titration windows. Hence, Viking plans to evaluate further dose escalation in the upcoming phase II trial. Based on phase I results, the company plans to initiate a phase I study of VK2735 in patients with obesity in mid-2023.
The company has initiated a phase I study to evaluate a novel oral formulation of VK2735. This study is an extension of the company's recently completed phase I evaluation of subcutaneously administered VK2735 and will evaluate daily oral doses for 28 days.
Biomea Surges on Study Data: Shares of the clinical-stage biopharmaceutical company Biomea Fusion, Inc. BMEA surged significantly after the company announced initial positive top-line data on BMF-219. Data was announced for the first two cohorts of patients with type 2 diabetes mellitus (T2DM) enrolled in the phase II portion of its ongoing phase I/II clinical study (COVALENT-111) of BMF-219.
Data showed 89% of patients achieved a reduction in HbA1c, 78% achieved at least a 0.5% reduction in HbA1c and 56% achieved at least a 1% reduction in HbA1c in Cohort 3 after four weeks of once-daily 100 mg dosing with the investigational, oral covalent menin inhibitor. Initial observations of continued glycemic control were seen in follow-up visits in patients that had already reached week eight in the study (four weeks after the last BMF-219 dose). BMF-219 demonstrated a well-tolerated safety profile. No patients on BMF-219 discontinued dosing and all patients completed four weeks of treatment. Biomea continues dose escalation of BMF-219 in COVALENT-111 and plans to explore additional dosing periods greater than four weeks to evaluate the optimal duration of glycemic control.
Biomea currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Intra-Cellular Soars on Depression Drug Data: Shares of Intra-Cellular Therapies, Inc. ITCI announced positive top-line results from study 403 evaluating lumateperone 42mg as monotherapy in the treatment of major depressive episodes in patients with major depressive disorder (MDD) with mixed features and patients with bipolar depression with mixed features.
Lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for each patient population. Lumateperone 42mg was statistically significant on the key secondary endpoint of the clinician’s assessment of improvement in the overall severity on the Global Impression of Severity Scale (CGI-S) compared to placebo at week six in the combined patient population of MDD with mixed features and bipolar depression with mixed features, patients with MDD with mixed features and patients with bipolar depression with mixed features.
Lumateperone is already approved under the brand name Caplyta for the for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Incyte Suffers Setback: Incyte INCY announced that the FDA has issued a complete response letter (CRL) for ruxolitinib extended-release (XR) tablets, a JAK1/JAK2 inhibitor, for once-daily (QD) use in the treatment of certain types of myelofibrosis (MF), polycythemia vera (PV) and graft-versus-host disease (GVHD). The CRL indicates that the FDA cannot approve the application in its present form as even though the study submitted in the new drug application (NDA) met its objective of bioequivalence based on area under the curve (AUC) parameters, it identified additional requirements for approval. Hence, the company will meet the FDA to determine the next steps.
Ruxolitinib is currently approved by the FDA for the treatment of PV in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk MF, including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Updates From Regeneron: Regeneron Pharmaceuticals, Inc. REGN announced that the European Commission (EC) approved a label expansion of Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression. The approval includes patients with no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.
Regeneron also announced a collaboration with Sonoma Biotherapeutics, Inc. to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T-cell therapies for autoimmune diseases.
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The Nasdaq Biotechnology Index has gained 0.68% in the past five trading sessions. Among the biotech giants, Regeneron has gained 8.85% during the period. Over the past six months, shares of Gilead have soared 28.91%. (See the last biotech stock roundup here: Biotech Stock Roundup: ALT Obesity Data, GILD Exercises Option, INCY Drug Approval)
What's Next in Biotech?
Stay tuned for other updates.
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