Biocryst HAE Data, BioAge BGE-102 Trial, Alebund Interim Results

Biocryst Pharmaceuticals will present new clinical trial and real-world data on its treatments for hereditary angioedema (HAE) at this year's American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting. BioAge Labs is advancing its oral NLRP3 inhibitor BGE-102 into a Phase 2 cardiovascular trial, and Alebund Pharmaceuticals announced interim results including Chinese regulatory acceptance of its AP301 new drug application.

Biocryst will present six abstracts reporting updated findings on Orladeyo (berotralstat), an approved oral medication used to help prevent swelling attacks in people ages 2 and older with HAE. These include interim results from the ongoing Phase 3 APeX-P trial (NCT05453968), which is evaluating the safety and pharmacological properties of once-daily Orladeyo oral granules in 29 children ages 2 to less than 12, with follow-up lasting up to nearly three years. Among the 29 children, the median monthly rate of moderate attacks declined from 0.33 during standard care to 0.16 with Orladeyo, while the rate of severe attacks fell from 0.31 to zero per month. The percentage of days with HAE symptoms decreased from a median of 9% during standard care to 3% during treatment. No patients discontinued due to adverse events. Data from APeX-P supported the recent extended approval of Orladeyo by the U.S. Food and Drug Administration to children ages 2-11, authorizing a new oral pellet formulation. After one year, 70.4% of children were attack-free, and the median monthly attack rate fell to zero early in treatment and remained at that level for most of the first year.

Three additional abstracts will present new clinical trial results on navenibart, an investigational treatment designed to help prevent HAE attacks and potentially reduce how often injections are needed. These include a late-breaking abstract reporting positive interim results from the ongoing Phase 2 ALPHA-SOLAR trial (NCT06007677), an open-label extension study evaluating long-term outcomes in 29 adults with HAE who previously enrolled in the Phase 2 ALPHA-STAR trial (NCT05695248). Navenibart is a long-acting antibody therapy designed to block kallikrein and is given as a subcutaneous injection every 3 or 6 months. Updated interim findings showed attack-rate reductions were maintained for up to 24 months: 92% mean reduction in those treated every three months and 90% in those treated every six months. Navenibart is now being evaluated in the Phase 3 ALPHA-ORBIT trial.

BioAge Labs is advancing BGE-102, an oral, once-daily NLRP3 inhibitor, into two simultaneous proof-of-concept trials targeting mid-2026 enrollment. Phase 1 data showed an 86% median reduction in hsCRP from baseline, with 87-93% of participants on active BGE-102 reaching normalized hsCRP below 2 mg/L. The Phase 2 dose-ranging trial in participants with elevated cardiovascular risk is expected to report topline data by year-end 2026. A Phase 1b/2a trial in diabetic macular edema is anticipated to have data by mid-2027.

Alebund Pharmaceuticals announced its unaudited consolidated interim results for the six months ended June 30, 2026. In May 2026, RESPOND-2, the global Phase III pivotal multi-regional clinical trial of AP301 conducted in the United States and China, completed patient enrollment. On August 7, 2026, the New Drug Application for AP301 for the treatment of hyperphosphatemia in chronic kidney disease patients receiving maintenance dialysis was accepted for review by the National Medical Products Administration of China as a Class 1 chemical drug. The global Phase IIb multi-regional clinical trial of AP306 has been initiated, co-sponsored with R1 Therapeutics, planning to enroll approximately 168 participants with hyperphosphatemia receiving maintenance hemodialysis; the first participant was randomized and dosed in July 2026, and the trial is expected to be completed in the second quarter of 2027. Data from three completed Phase I/Ib clinical trials of AP303 were published in Kidney International Reports in August 2026, demonstrating that AP303 was safe and well tolerated, with expected dose-related hemodynamic effects observed in healthy participants and patients with diabetic kidney disease. Preclinical results for AP308 published in May 2026 in Kidney International showed that in humanized IgA nephropathy mouse models, AP308 reduced circulating human IgA1 by approximately 90% after a single dose, and eight weeks of treatment achieved near-complete clearance of glomerular IgA deposits with significant improvement in renal pathology and no treatment-related adverse effects.

BioAge's R&D spend nearly doubled year-over-year, from $11.1 million to $20.4 million in Q1 2026, driven primarily by Phase 1 completion costs and Phase 2 preparation. The company raised $132.3 million in January. Collaboration revenue from the Novartis collaboration and the Lilly ExploR&D partnership was $2.8 million in the quarter.

During the reporting period, Alebund recognized licensing revenue of RMB79.3 million from licensing and equity agreements with R1 Therapeutics for AP306. Sales revenue of Mircera increased by approximately 105.0% year-on-year to RMB24.8 million. Revenue for the first half of 2026 grew to RMB104.2 million from RMB12.1 million, an increase of 761.2%. Loss for the period was RMB162.6 million, narrowing by 22.5% year-on-year. The company's H Shares were listed on the Main Board of the Stock Exchange of Hong Kong Limited on June 29, 2026, and aggregate net proceeds from the Global Offering amounted to approximately HK$1,355.8 million.