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News - Rallybio Reports Phase 1 Data for RLYB116 Showing Sustained Complement Inhibition

Image Credit: Rallybio


February 2026 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group


On Feb. 17, 2026, Rallybio Corporation reported positive results from a Phase 1 confirmatory clinical study of RLYB116, an investigational subcutaneous C5 inhibitor being developed for complement-mediated diseases. The company said the data demonstrated complete and sustained inhibition of terminal complement activity at the highest dose tested, supporting further clinical development.

RLYB116 is designed as a once-weekly, small-volume subcutaneous injection and is being evaluated initially for immune platelet transfusion refractoriness and refractory antiphospholipid syndrome. Rallybio said the results from the Phase 1 pharmacokinetic and pharmacodynamic study support the program’s potential as a differentiated treatment option for diseases driven by complement activation.

“The results from our Phase 1 study of RLYB116 are both validating and highly encouraging, reinforcing our belief that this program has the potential to be a best-in-class therapeutic. At the 300 mg dose, we achieved complete and sustained inhibition of terminal complement with a safety profile consistent with other subcutaneous biologics,” said Stephen Uden, M.D., co-founder and chief executive officer of Rallybio. “These data underscore the potential of RLYB116 to deliver rapid onset, durable activity, and patient-friendly administration through a small volume, off-the-shelf autoinjector—features that could transform care for individuals living with complement-mediated diseases such as immune platelet transfusion refractoriness and antiphospholipid syndrome.”

The single-blind, multiple ascending dose Phase 1 study was conducted in healthy volunteers and was designed to assess the ability of RLYB116 to achieve sustained complement inhibition while maintaining favorable tolerability. The trial included two cohorts of eight participants each, randomized in a 3-to-1 ratio to receive either RLYB116 or placebo once weekly for four weeks. One cohort received a 150 mg dose, while the second cohort received a 300 mg dose, followed by a 10-week observation period.

According to Rallybio, the 300 mg once-weekly dose achieved complete and sustained inhibition of terminal complement, as measured by ex vivo hemolytic activity. The company said this finding is consistent with clinically effective blockade of the terminal complement pathway. Both the 150 mg and 300 mg doses were reported to be well tolerated, with no gastrointestinal side effects observed. The most common adverse events were mild to moderate injection site reactions, which did not lead to treatment discontinuation.

“With these results in hand, we have the potential to move into a Phase 2 proof of concept study in immune PTR, in 2H 2026. We remain steadfast in our belief that RLYB116 has significant value as a potential best-in-class therapy for patients with high unmet need,” Dr. Uden said.

Rallybio said it plans to initiate a Phase 2 clinical trial of RLYB116 in immune platelet transfusion refractoriness in the second half of 2026, with the possibility of topline data in 2027.

“Based on our prior clinical experience, the Phase 1 results are compelling and provide strong corroboration for our scientific and clinical rationale. The data demonstrate the potential for rapid onset and sustained activity, offering clinical benefit and flexibility for a convenient dosing regimen that addresses a significant unmet need for patients with immune PTR, APS and other complement mediated diseases,” said Steven Ryder, M.D., chief medical officer of Rallybio.

COPY: Rallybio reported positive Phase 1 data for RLYB116, showing complete and sustained terminal complement inhibition with weekly dosing, supporting plans to advance the therapy into Phase 2 studies.
 

Editor’s Corner



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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