First Patient In: Weekly Clinical Trials Briefing

Oct 31, 2026

This week at a glance

We tracked seven first-patient-in milestones between 24 and 31 October. The US led with four, including a global Phase 3 start for Nacuity in Usher syndrome and Enanta’s Phase 2b/3 RSV trial. In Asia, Nuance Pharma began a Phase III allergy trial in China and Suzhou-based Adagene saw its first patient dosed in a combination study with Incyte. Australia’s Arovella dosed its first patient with an off-the-shelf cell therapy, and Europe had no new starts. At the end you’ll find a summary of the trials that reached full enrollment. Each item links to the full release.

United States

The biggest US start came in ophthalmology. On 28 October, Nacuity Pharmaceuticals dosed the first patient in SLO-RP Preserve, a global confirmatory Phase 3 trial of NPI-001 (N-acetylcysteine amide) tablets in adults with retinitis pigmentosa associated with Usher syndrome, an inherited cause of combined deafness and blindness. Results are not expected before 2029. Read the full release.

The same day, Palisade Bio dosed the first patient in ASCENTRA-UC, a global Phase 2b trial of PALI-2108 in about 204 patients with moderately to severely active ulcerative colitis. PALI-2108 is a once-daily oral PDE4 inhibitor prodrug that is activated in the gut, designed to reduce the side effects that limit existing PDE4 drugs. Read the full release.

Infectious disease also had a late-stage start. On 26 October, Enanta Pharmaceuticals dosed the first patient in RESOLVE, a Phase 2b/3 study of zelicapavir, an oral antiviral it describes as a potential first-in-disease treatment for respiratory syncytial virus (RSV). Read the full story.

In oncology, Xilio Therapeutics dosed the first patient on 26 October in a first-in-human Phase 1/2 trial of XTX501, a PD-1/masked IL-2 bispecific fusion protein, in metastatic non-small cell lung cancer, at multiple US sites. The trial design will be presented in Phoenix on 7 November, with initial Phase 1 data expected in Q4 2027. Read the full release.

Asia

China’s headline start this week was a late-stage allergy trial. On 30 October, Shanghai-based Nuance Pharma dosed the first patient in REACH, a randomized, double-blind, placebo-controlled Phase III trial of STG320 (Actair), a sublingual immunotherapy tablet for house dust mite-induced allergic rhinitis, with or without asthma. Patients will be treated for 12 months, and Nuance says the trial builds on its early access programs as it works to bring the treatment to Chinese patients. Read the full release.

Adagene, which is based in Suzhou and San Diego, said on 28 October that the first patient has been dosed in a Phase 1 study combining its masked anti-CTLA-4 antibody muzastotug with Incyte’s TGFβR2 × PD-1 bispecific INCA33890 in third-line microsatellite stable colorectal cancer, including patients with liver metastases. Incyte is sponsoring and running the study, with Adagene supplying muzastotug. Read the full release.

We found no first-patient-in announcements from Japanese or Korean sponsors between 24 and 31 October. Much of the region’s attention was on ESMO 2026 in Madrid, where Asian sponsors presented a run of Phase 1 to 3 data.

Australia

The Australian start we flagged last week has happened. On 27 October, Melbourne’s Arovella Therapeutics told the ASX it had dosed the first patient in SAPPHIRE (NCT07518329), its first-in-human Phase 1 trial of ALA-101, an allogeneic, off-the-shelf CD19 CAR-iNKT cell therapy for relapsed or refractory CD19-positive non-Hodgkin lymphoma and leukemia. The patient was treated at The Alfred under lead investigator Dr Sam Fiorenza after standard lymphodepleting chemotherapy. Because ALA-101 is made in batches from healthy donor cells rather than each patient’s own cells, Arovella says it could be delivered faster and more cheaply than conventional CAR-T. Initial data are expected early in 2027. Read the ASX announcement.

Europe

We found no first-patient-in announcements from European sponsors between 24 and 31 October. European biotechs spent the week presenting data rather than starting trials, with ESMO 2026 in Madrid and ASN Kidney Week dominating the news flow. The most recent European start remains Warsaw-based JJP Biologics, which dosed its first rheumatoid arthritis patients with the anti-CD89 antibody nebaprubart on 19 October (full release).

What to watch

Xilio will present the XTX501 trial design on 7 November, and Arovella expects initial ALA-101 data early in 2027. In Australia, the next starts to watch are other ASX-listed biotechs reporting in their quarterly updates, which are due by the end of October. Have a first-patient-in milestone to share? Reply to this newsletter and we will consider it for next week’s edition.

Fully recruited: enrollment completions, 24 to 31 October

It was a quiet week for enrollment completions. The one we found came from Vor Bio, which confirmed in its third-quarter update on 30 October that enrollment is complete in UPSTREAM MG, its global, placebo-controlled Phase 3 registrational trial of telitacicept in generalized myasthenia gravis. Topline data are expected in the first half of 2027. Read the full story.

Just before the window, Newron closed the trial we have been tracking in recent editions. On 22 October it said the pivotal Phase 3 ENIGMA-TRS 1 study of evenamide in treatment-resistant schizophrenia is fully enrolled, with 618 of 996 screened patients randomized to one of two doses or placebo. Read the full release. We found no enrollment completions from Asia-Pacific sponsors, including Australia, this week.