This is a Phase 3 multicenter trial in 2 parts to evaluate the long-term safety and efficacy of navenibart in adult and adolescent participants with hereditary angioedema (HAE) who participated in STAR-0215-301 (NCT06842823; ALPHA-ORBIT). Part 1 provides all participants with navenibart in a dose-controlled fashion; Part 2 introduces a personalized dosing option (PDO) for participants based on individual needs.

Start Date01 Oct 2025

Sponsor / Collaborator

Astria Therapeutics, Inc.

NCT06842823

/ RecruitingPhase 3

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Navenibart in Participants With Hereditary Angioedema (HAE)

This is a Phase 3 multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the safety and efficacy of subcutaneous administration of navenibart in adult and adolescent participants with type 1 or type 2 hereditary angioedema (HAE). The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.

Start Date20 Mar 2025

Sponsor / Collaborator

Astria Therapeutics, Inc.

NCT06007677

/ Active, not recruitingPhase 2

A Phase 2 Long-Term Open-Label Trial to Assess the Safety and Efficacy of Repeat Dosing of STAR-0215 in Adult Patients With Hereditary Angioedema (The ALPHA-SOLAR Trial)

The goal of this trial is to enable the collection of information about long-term safety and clinical activity of STAR-0215 in participants with hereditary angioedema (HAE). Participants will receive repeat doses of STAR-0215 for up to 5 years.

Start Date26 Sep 2023

Sponsor / Collaborator

Astria Therapeutics, Inc.

100 Clinical Results associated with Navenibart

100 Translational Medicine associated with Navenibart

100 Patents (Medical) associated with Navenibart

Literatures (Medical) associated with Navenibart

01 Jul 2025·ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults

Article

Author: Morabito, Christopher ; Cohen, Theodora ; Lumry, William ; Gunsior, Michele ; Gustafson, Pamela ; Bernard, Kristine ; Chung, Jou-Ku

BACKGROUND:

Hereditary angioedema (HAE) is a rare, autosomal-dominant disorder characterized by bradykinin-mediated episodic, localized swelling that can be fatal. Currently approved long-term prophylactic therapies for HAE attacks incur substantial treatment burden through frequent dosing. Navenibart (STAR-0215) is a monoclonal antibody inhibitor of plasma kallikrein modified to extend circulating half-life and is under investigation for HAE prophylaxis.

OBJECTIVE:

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of navenibart in healthy adults and to assess the feasibility of every 3- and 6-month dosing.

METHODS:

In this phase 1a study, participants were randomized 3:1 to receive placebo or navenibart in escalating (100-1200 mg) dosing cohorts. Safety outcomes, including treatment-emergent adverse events (TEAEs) and serious AEs, were monitored until the end of the study (day 224). Additional end points included pharmacokinetic parameters and inhibition of plasma kallikrein activity.

RESULTS:

In total, 31 participants received navenibart and 10 received placebo. The median age of the participants was 36 years; 53.7% were male; 51.2% were Black or African American. Rates of TEAEs were similar between navenibart and placebo, and no serious AEs were reported. Navenibart-related TEAEs included injection site reactions, inclusive of erythema, pruritus, and swelling, which resolved without intervention. For all doses more than or equal to 300 mg, navenibart mean half-life ranged from 82 to 105 days and inhibition of factor XIIa-induced plasma kallikrein activity vs placebo was statistically significant (P < .05). Statistically significant inhibition of factor XIIa-induced plasma kallikrein activity vs placebo (P < .05) was observed with all doses of navenibart.

CONCLUSION:

In this first-in-human study, up to 1200 mg of navenibart was well tolerated and demonstrated an extended half-life with durable plasma kallikrein inhibition.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT05477160.

01 Nov 2023·The Journal of pharmacology and experimental therapeutics

STAR-0215 is a Novel, Long-Acting Monoclonal Antibody Inhibitor of Plasma Kallikrein for the Potential Treatment of Hereditary Angioedema

Article

Author: Bista, Pradeep ; Chandran, Sachin ; Omer, Charles ; Fuller, James ; Kiselak, Tomas ; Dagher, Rafif ; Bedian, Vahe ; Nichols, Andrew ; Violin, Jonathan ; Chung, Jou-Ku ; Biris, Nikolaos ; Harwin, Peter

Hereditary angioedema (HAE) is a rare autosomal dominant disorder caused by a deficiency in functional C1 esterase inhibitor, a serpin family protein that blocks the activity of plasma kallikrein. Insufficient inhibition of plasma kallikrein results in the overproduction of bradykinin, a vasoactive inflammatory mediator that produces both pain and unpredictable swelling during HAE attacks, with potentially life-threatening consequences. We describe the generation of STAR-0215, a humanized IgG1 antibody with a long circulating half-life (t_1/2) that potently inhibits plasma kallikrein activity, with a >1000-fold lower affinity for prekallikrein and no measurable inhibitory activity against other serine proteases. The high specificity and inhibitory effect of STAR-0215 is demonstrated through a unique allosteric mechanism involving N-terminal catalytic domain binding, destabilization of the activation domain, and reversion of the active site to the inactive zymogen state. The YTE (M252Y/S254T/T256E) modified fragment crystallizable (Fc) domain of STAR-0215 enhances pH-dependent neonatal Fc receptor binding, resulting in a prolonged t_1/2 in vivo (∼34 days in cynomolgus monkeys) compared with antibodies without this modification. A single subcutaneous dose of STAR-0215 (≥100 mg) was predicted to be active in patients for 3 months or longer, based on simulations using a minimal physiologically based pharmacokinetic model. These data indicate that STAR-0215, a highly potent and specific antibody against plasma kallikrein with extended t_1/2, is a potential agent for long-term preventative HAE therapy administered every 3 months or less frequently. SIGNIFICANCE STATEMENT: STAR-0215 is a YTE-modified immunoglobulin G1 monoclonal antibody with a novel binding mechanism that specifically and potently inhibits the enzymatic activity of plasma kallikrein and prevents the generation of bradykinin. It has been designed to be a long-lasting prophylactic treatment to prevent attacks of HAE and to decrease the burden of disease and the burden of treatment for people with HAE.

118

News (Medical) associated with Navenibart

14 Oct 2025

·www.fiercepharma.com

BioCryst inks $700M Astria buyout to challenge Takeda for rare disease market

Top-line phase 3 data on navenibart are due in early 2027. Having already established a commercial infrastructure for its oral hereditary angioedema (HAE) drug Orladeyo and eager to pinpoint the source of its future growth, BioCryst Pharmaceuticals has struck a $700 million deal to buy Astria Therapeutics. The deal will give the rare disease specialist control of a phase 3 challenger to Takeda’s HAE therapy Takhzyro.North Carolina-based BioCryst already sells the daily oral capsule Orladeyo, which won approval in 2020 to prevent HAE attacks in patients 12 and older. Forecasting that Orladeyo sales will peak at $1 billion around the end of the decade, the company has been investing in drug discovery and scouting around for deals to drive its next phase of growth.The search has resulted in an agreement to buy Astria for $13 a share, a 53% premium over the acquired biotech’s closing share price Monday.BioCryst is buying Astria for navenibart, an injectable, long-acting inhibitor of plasma kallikrein. Takeda already sells an injectable plasma kallikrein inhibitor, Takhzyro, which is administered every two or four weeks.On a call with investors to discuss the deal, Charlie Gayer, chief commercial officer at BioCryst, said roughly 5,000 HAE patients in the U.S. use existing injectable prophylaxis therapies despite needing to receive frequent, sometimes painful injections. “What if they could control their attacks with similar efficacy with an injection that doesn’t hurt and do it two to four times per year instead of 24 or even 12 times per year?” Gayer said. “Low dosing frequency is the main remaining unmet need identified by HAE patients and their physicians. They see every-three-month dosing as the tipping point that would motivate a switch. That is the potential of navenibart.”Evidence that navenibart has the profile targeted by BioCryst comes in part from an open-label trial that delivered data in June. Astria linked three-month dosing to a 95% mean monthly attack-rate reduction. The reduction in the six-month cohort was 86%. Gayer said achieving three-month dosing is the most important goal, while showing six-month dosing is effective would be “icing on the cake." Astria is studying both regimens in a phase 3 trial that started enrolling patients this year. Top-line data are due in early 2027. The timeline informed Gayer’s belief that navenibart is likely to be the first HAE drug to launch with the three-month dosing that BioCryst has identified as key to persuading patients to switch from Takhzyro. If navenibart wins approval, BioCryst expects to largely rely on the operation it built to support Orladeyo to launch the drug. The low level of investment needed for commercialization and timing of the launch, which is scheduled for around when Orladeyo sales are forecast to plateau, led BioCryst Chief Financial Officer Babar Ghias to predict navenibart can “supercharge” earnings growth well into the next decade. Astria’s pipeline also includes an OX40 antagonist, STAR-0310, that is in development for the treatment of eczema. BioCryst plans to seek strategic alternatives for the asset. Jon Stonehouse, CEO of BioCryst, told investors STAR-0310 is “a really interesting product” but is outside the biotech’s focus on rare disease. That led the CEO to conclude the asset is “better in the hands of somebody that's in that area.”

Phase 3AcquisitionDrug ApprovalClinical ResultNDA

14 Oct 2025

·endpoints.news

BioCryst to acquire Astria for $700M, adding a second HAE drug

BioCryst Pharmaceuticals plans to buy Astria Therapeutics for around $700 million in cash and stock. The deal, announced Tuesday, means BioCryst will get a drug intended to prevent hereditary angioedema (HAE), an area in which it already specializes. The Durham, NC-based company will pay $8.55 in cash and 0.59 shares of its common stock per share of Astria stock, implying a value of $13.00 per share or around $700 million in enterprise value for Astria. That is a premium of about 53% over Astria’s closing share price $ATXS on Monday. BioCryst has also arranged a financing facility worth up to $550 million with funds managed by Blackstone. It expects the cash portion of the deal to be funded with cash on hand and part of the Blackstone facility. BioCryst’s shares $BCRX fell as much as 14% premarket and were later down about 9%. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard! You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Hello, Crystal Howard. You’re an essential part of the biopharma world. Share your voice on this subscriber Pulse Survey to help shape our understanding of the industry. Results will be anonymous. Astria’s lead candidate is an injected kallikrein inhibitor named navenibart, which is intended to prevent the episodes of severe swelling in the limbs, face, intestinal tract and airway that characterize HAE. The company expects to have topline data from an ongoing Phase 3 study of the drug called ALPHA-ORBIT in early 2027. Navenibart still has to prove itself effective, but BioCryst believes that the drug’s real advantage is its dosing schedule. The drug can potentially be injected every six or even nine months. The leading product sold to prevent HAE is Takeda’s Takhzyro, which was approved in 2023. It’s an effective medication but must be injected every two weeks. “The market isn’t looking for more efficacy. What it’s looking for is less burdensome dosing, and that’s what navenibart has the potential to provide,” BioCryst President and Chief Commercial Officer Charlie Gayer said Tuesday on a conference call. BioCryst also sells an HAE preventive called Orladeyo. The oral plasma kallikrein inhibitor was approved in 2020 . BioCryst CEO Jon Stonehouse said on the call that Orladeyo was “on its way to $1 billion at peak around the end of the decade.” It had sales of $157 million in the second quarter of 2025. BioCryst believes that having two products to prevent the same disease makes sense. “Brand-new patients to [prophylaxis] really prefer oral. Patients who are already doing well on an injectable would prefer to have an injectable that even better meets their needs, specifically with dosing,” Gayer said on the call. BioCryst said its sales infrastructure and expertise in HAE could maximize the reach of navenibart, which it believes could be the best drug in its class alongside having a dosing advantage. If the late-stage trials pan out, it could end up claiming a substantial slice of the roughly 5,000 patients who already take an injected preventive therapy for HAE. Gayer, who is set to take over as BioCryst’s CEO in January, said the company believes that navenibart and Orladeyo could have combined sales of “at least $1.8 billion by 2033.” BioCryst sold its European Orladeyo business in June to pay off debt. Under the deal, BioCryst will also gain Astria’s program for atopic dermatitis, STAR-0310. But it doesn’t plan to keep the asset. BioCryst said it would seek strategic alternatives for STAR-0310, which is in a Phase 1 trial in healthy volunteers. Even after absorbing the R&D costs of navenibart, BioCryst will “remain highly profitable on a non-GAAP basis and cash flow positive,” CFO Babar Ghias said on the call. The company declined to say if there were other bidders for Astria. When the deal closes, which is expected in the first quarter of next year, Astria CEO Jill Milne will join BioCryst’s board. Milne said the deal was “a compelling outcome for Astria stockholders.” Astria stockholders will own roughly 15% of equity in the combined company.

Drug ApprovalPhase 3Phase 1

14 Oct 2025

·firstwordpharma.com

BioCryst adds Astria's HAE injectable in $700M takeout

BioCryst Pharmaceuticals is broadening its reach in hereditary angioedema (HAE) with a deal to buy Astria Therapeutics, gaining a late-stage injectable therapy to complement its existing oral drug Orladeyo (berotralstat). The tie-up could bolster BioCryst's position in a market now edging toward gene-editing approaches that promise lifelong control of angioedema attacks.Under the terms announced Tuesday, BioCryst will pay $8.55 in cash and 0.59 shares of its common stock for each Astria share, representing an implied value of $13 per share, which represents a 53% premium to Astria's closing price on October 13. The deal, valuing the combined enterprise at about $700 million, is expected to close in the first quarter of 2026.Quarterly, twice-yearly dosingThe acquisition centres on navenibart (STAR-0215), a monoclonal antibody that inhibits plasma kallikrein. In the long-term, open-label ALPHA-SOLAR study reported in June, navenibart cut monthly attack rates by an average of 92% — with up to 95% reduction in patients receiving injections every three months and 86% in those dosed every six months.The therapy's extended dosing interval addresses a key patient need in a market where treatment dissatisfaction runs high. Ionis Pharmaceuticals' RNA-targeting preventive shot Dawnzera (donidalorsen), which scored an FDA approval in August, has demonstrated an 81% reduction in HAE attacks with monthly dosing, compared to placebo. In a recent interview with FirstWord, CEO Brett Monia cited an independent survey finding that 90% of HAE patients would switch treatments if they found better efficacy, tolerability or convenience (see – ViewPoints: How Ionis' Dawnzera stands out from the HAE prophylaxis pack).Meanwhile, gene-editing approaches could eliminate the need for ongoing prophylaxis. Intellia Therapeutics last month completed enrollment for its Phase III HAELO trial of lonvoguran ziclumeran (NTLA-2002), an in vivo CRISPR-based therapy that inactivates the gene encoding kallikrein precursor protein. Last year, it reported that the one-time treatment reduced HAE attacks by over 80% in Phase II testing. Intellia expects to report top-line data from HAELO in the first half of 2026 and plans a US launch in early 2027.'Perfect second product'Jon Stonehouse, BioCryst's chief executive, described navenibart as "a perfect second product candidate" that fits with his company's HAE focus. The therapy "can emerge as the injectable of choice for patients seeking infrequent, pain-free dosing, strong attack control, and a mechanism of action they know and understand," he said.Top-line data from navenibart's pivotal Phase III ALPHA-ORBIT trial are expected in early 2027, with a potential commercial launch targeting more than 5000 patients currently using injectable prophylaxis.If navenibart ultimately succeeds, it could allow BioCryst to offer both oral and injectable options in a space where current therapies face tolerability challenges. Takeda's Takhzyro (lanadelumab-flyo), the standard-of-care injectable, can be painful to administer and causes injection-site reactions, while Orladeyo — which was approved by the FDA in 2020 — produces gastrointestinal effects that can be confused with HAE attacks.BioCryst recently completed the sale of its European Orladeyo business to Neopharmed Gentili for $250 million, with a view to concentrating on its core US business.

Drug ApprovalPhase 3AcquisitionPhase 2

100 Deals associated with Navenibart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Hereditary Angioedema Types I and II	Phase 3	United States	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	Bulgaria	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	Canada	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	Hong Kong	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	Netherlands	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	Poland	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	South Africa	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema Types I and II	Phase 3	United Kingdom	Astria Therapeutics, Inc.	20 Mar 2025
Hereditary Angioedema	Phase 2	Germany	Astria Therapeutics, Inc.	26 Sep 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06007677 (ALPHA-SOLAR, PipelineReview) Manual	Phase 2	Hereditary Angioedema	16	navenibart (600 mg / 300 mg Q3M)	aqrzsdzagk(bvqnxosqfc) = iiorqorima bymsnuoqoe (fonvuqsasj ) View more	Positive	13 Jun 2025
				navenibart (600 mg / 600 mg at Day 28, 600 mg Q6M)	aqrzsdzagk(bvqnxosqfc) = xnxykqblem bymsnuoqoe (fonvuqsasj ) View more
NCT05477160 (Pubmed) Manual	Phase 1	-	41	navenibart	ybrfwtvbnw(mydhwtdeff) = Rates of TEAEs were similar between navenibart and placebo, and no serious AEs were reported. Navenibart-related TEAEs included injection site reactions, inclusive of erythema, pruritus, and swelling, which resolved without intervention. wwpitacadr (rrxolldjkh ) View more	Positive	01 Mar 2025
				Placebo
NCT05695248 (ALPHA-STAR, ACAAI2024)	Phase 1/2	Hereditary Angioedema HAE-C1INH-Type1/2	16	STAR-0215 450 mg	hytxhljnsz(fdfccepxpe) = fawncicxhf jjpkakgckp (kxqrxkucym, 13.4) View more	Positive	24 Oct 2024
				STAR-0215 600 mg	hytxhljnsz(fdfccepxpe) = yepdymwdgn jjpkakgckp (kxqrxkucym, 19.8) View more
NCT05695248 (ALPHA-STAR, Biospace) Manual	Phase 1/2	Hereditary Angioedema	16	STAR-0215 450 mg (6 months of follow-up)	wjaahptudt(vyfdixmlws) = ygnjtrjhba vgczdyisls (ladgtwclab ) View more	Positive	25 Mar 2024
				STAR-0215 600mg+300mg(three months later) (6 months of follow-up)	wjaahptudt(vyfdixmlws) = kurewsgaep vgczdyisls (ladgtwclab ) View more
NCT05477160 (AAAAI2024) Manual	Phase 1	Hereditary Angioedema cleaved high-molecular-weight-kininogen (cHMWK)	41	STAR-0215 1200 mg SC	zjpbgrpjdq(lhostygzsl) = were seen in 10 STAR-0215 and 1 placebo subjects, most commonly injection site reactions (n=9). wcyfyshupe (bnslqcjdze ) View more	Positive	23 Feb 2024
NCT05695248 (ALPHA-STAR, PipelineReview) Manual	Phase 1	Hereditary Angioedema	-	STAR-0215	orngwzieyh(eevembftfj) = STAR-0215 was well-tolerated, with no serious adverse events or discontinuations due to an adverse event, and low risk of injection pain swgvveddnw (jouddipotm ) View more	Positive	10 Nov 2023

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