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After two meetings with the U.S. Food and Drug Administration (FDA), <a href="https://coyatherapeutics.com/">Coya Therapeutics</a> says it&#8217;s received constructive feedback — and has reached an alignment with the agency regarding development plans for COYA 302, its therapy candidate for people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
The company held the two meetings — a pre-investigational new drug (IND) meeting and a type C meeting — to seek advice from the FDA. Now, according to COYA, the two parties are in agreement regarding key areas of COYA 302&#8217;s development, to include its manufacturing, preclinical research, and clinical studies, which should support the filing of an IND application seeking clearance to start clinical trials.
That application is expected to be submitted in the first half of 2024, the company said in a <a href="https://www.businesswire.com/news/home/20240105424614/en/Coya-Therapeutics-Announces-Successful-Pre-IND-and-Type-C-Meetings-with-the-FDA-to-Advance-the-Development-of-COYA-302-for-Treatment-of-Amyotrophic-Lateral-Sclerosis-ALS">press release</a>.
If it&#8217;s accepted, Coya will soon thereafter launch a double-blind clinical trial to test COYA 302 in people with ALS. In a double-blind study, neither researchers nor participants know what treatment, if any, patients are receiving.
“This important feedback allows us to advance our development program in ALS with a planned double-blind controlled study, with the potential for bringing forward a much-needed therapy for ALS patients,” said Fred Grossman, Coya’s president and chief medical officer.
[recommended-reading id=82985]
<h3>In proof-of-concept study, COYA 302 showed marked benefits</h3>
ALS is characterized by progressive damage to motor neurons, the nerve cells that control voluntary movements. It renders the brain less able to control muscle movements.
<a href="https://coyatherapeutics.com/science-and-technology/">COYA 302</a> is an experimental approach that combines a low dose of the immune signaling molecule interleukin-2 (IL-2) and a fusion protein named CTLA-4 Ig (abatacept).
IL-2 is intended to reduce inflammation by increasing the levels and activity of anti-inflammatory immune cells called regulatory T-cells, or Tregs. CTLA-4 Ig, meanwhile, aims to decrease the activity of immune cells that promote inflammation and damage in ALS.
The therapy, administered via a subcutaneous or under-the-skin injection, has already been tested in four ALS patients in a proof-of-concept clinical trial. The participants received treatment for 48 weeks, or nearly one year, and were followed for eight more weeks after stopping COYA 302.
Results of the small study showed that ALS progression was markedly slowed during the treatment period, with patients experiencing similar levels of disability after 48 weeks compared with before treatment.
Prior to treatment, participants were losing a mean of 1.1 points per month in their ALS Functional Rating Scale (ALSFRS-R) scores, indicating a lower ability to perform daily tasks each month. During the entire study period, scores dropped a total of 1.5 points, on average.
However, once patients stopped COYA 302, progression rates returned to those observed before the trial started, indicating a need for continuous treatment.
Similarly, there was a statistically significant increase in Treg anti-inflammatory activity during the treatment, which also decreased to starting, or baseline, levels eight weeks after treatment discontinuation.
The study also evaluated biomarkers of inflammation and oxidative stress — a type of cell damage associated with inflammation. Available data up to 16 weeks, or about four months, suggested a decrease in these biomarkers, consistent with the observed increase in Treg function.
[quote=&#8221;center&#8221;]We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in [the second quarter of] 2024 is an important next step in advancing the program in patients with ALS.[/quote]
The therapy was generally well tolerated, with no serious side effects reported and no treatment discontinuations. The most common side effects were mild reactions at the injection site.
Coya plans to continue working closely with the FDA throughout COYA 302&#8217;s development program, the company said.
“We believe that gaining alignment with FDA through multiple regulatory meetings on the path to filing an IND in [the second quarter of] 2024 is an important next step in advancing the program in patients with ALS,” said Howard H. Berman, PhD, Coya’s CEO.

Coya aligns with FDA on plans for developing COYA 302 for ALS

Under a new agreement, Coya Therapeutics&#8217; <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) treatment candidate COYA 302 — which aims to suppress chronic and sustained inflammation — will now be exclusively marketed by <a href="https://www.drreddys.com">Dr. Reddy’s Laboratories</a> in the U.S., Canada, and the U.K., as well as in the European Union, should it be approved in those countries.
<a href="https://coyatherapeutics.com">Coya</a> will retain the rights to market COYA 302 in Japan, Mexico, and countries of South America. Additionally, the company will remain responsible for moving the experimental therapy through clinical development in the U.S. and dealing with regulatory matters.
The company is <a href="https://alsnewstoday.com/news/coya-meet-fda-about-phase-2-trial-coya-302-als/">preparing a meeting</a> with the U.S. Food and Drug Administration (FDA) to discuss its development plans for COYA 302 in advance of an investigational new drug (IND) application, which it plans to file in early 2024. That IND will seek FDA clearance to launch a Phase 2 clinical study of the combination therapy.
Under the terms of the agreement, India-based Dr. Reddy’s will make an upfront payment of $7.5 million. Additional payments of up to $40 million will follow should a number of development and regulatory milestones be achieved. Coya also could receive additional payments of up to $677.25 million based on sales milestones, as well as royalties on net sales.
“While the agreement provides the financial resources to execute on the Phase 2 clinical program for COYA 302 in ALS, the strategic value of the partnership contributes much more than capital,” Howard Berman, PhD, Coya’s CEO, said in a <a href="https://www.businesswire.com/news/home/20231206037106/en/Coya-Therapeutics-Inc.-and-Dr.-Reddy%E2%80%99s-Laboratories-Enter-into-an-Exclusive-Collaboration-for-Development-and-Commercialization-of-COYA-302-an-Investigational-Combination-Therapy-for-Treatment-of-Amyotrophic-Lateral-Sclerosis-ALS">press release</a>.
[recommended-reading id=82985]
<h3>2nd deal between Coya, Dr. Reddy&#8217;s this year on COYA 302</h3>
This agreement comes in addition to an <a href="https://ir.coyatherapeutics.com/news/news-details/2023/Coya-Therapeutics-Inc.-Announces-an-Agreement-with-Dr.-Reddys-Laboratories-Ltd.-to-License-its-proposed-biosimilar-Abatacept-for-the-Development-and-Commercialization-of-COYA-302-for-the-Treatment-of-Neurodegenerative-Diseases/default.aspx">in-licensing agreement</a> signed earlier this year, in which Dr. Reddy’s has allowed Coya to use its proposed biosimilar of abatacept — a fusion protein — as one of the components in COYA 302.
“We will benefit from and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS,” Berman said.
ALS occurs due to damage to motor neurons, the nerve cells in the brain and spinal cord that control movement. The exact mechanisms leading to nerve cell damage in ALS are unclear, but an overly active immune system is believed to play a role.
COYA 302 contains a combination of low-dose interleukin-2 (IL-2), a signaling molecule that&#8217;s intended to increase the activity of anti-inflammatory immune cells called <a href="https://alsnewstoday.com/tregs/">regulatory T-cells</a> (Tregs), and a fusion protein known as CTLA4-Ig or abatacept. Abatacept is designed to decrease the activity of immune cells that promote inflammation and damage in ALS.
The combination therapy is given via a subcutaneous, or under-the-skin, injection.
[quote=&#8221;center&#8221;]We will benefit from and leverage Dr. Reddy’s manufacturing expertise and growing commercial infrastructure both in the USA and worldwide as we plan together for the future of COYA 302 in ALS.[/quote]
A small proof-of-concept trial tested the therapy in four people with ALS, who received treatment at the Houston Methodist Research Institute, in Texas, for 48 weeks, or about 11 months.
The results showed a marked slowing in disease progression, with patients experiencing less than a 2-point decline in ALS Functional Rating Scale (ALSFRS-R) scores over the 11 months. That was in comparison to a 1.1 monthly decline before entering the study.
COYA 302 also increased the activity of regulatory T-cells while leading to a reduction in markers of inflammation and oxidative stress — a type of cell damage caused by excessive inflammation. The treatment was well tolerated, with the most common side effect being mild reactions at the site of injection.
“Patients with ALS, commonly known as Lou Gehrig’s disease, have very few <a href="https://alsnewstoday.com/als-treatment/">treatment options</a>,” said Marc Kikuchi, CEO at Dr. Reddy’s North America.
&#8220;We are pleased to partner with Coya Therapeutics on this investigational therapy which may have a unique place in treating patients with this progressive neurodegenerative disease,&#8221; Kikuchi said.

Coya, Dr. Reddy’s collaborate to advance COYA 302 for ALS

<a href="https://coyatherapeutics.com/">Coya Therapeutics</a> is planning to file a request with the U.S. Food and Drug Administration (FDA) to continue testing its investigational therapy COYA 302 for the treatment of <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) in a Phase 2 clinical trial.
The company is preparing a meeting with the regulatory agency to discuss its development plans and ensure they align with FDA expectations and requirements before submitting the investigational new drug (IND) application.
The pre-IND meeting will take place this fall, and the company is hoping to have the application cleared early next year, with plans to initiate the clinical trial soon thereafter.
“We are preparing for a pre-IND meeting with the FDA in the fall of 2023,” Howard Berman, PhD, CEO of Coya, said in a <a href="https://www.businesswire.com/news/home/20230808949580/en/Coya-Therapeutics-Inc.-Provides-Business-Update-and-Reports-Q2-2023-Unaudited-Financial-Results">company press release</a>. “We hope to have our IND application for a phase 2 trial accepted by the FDA early next year and are optimistic the trial can begin soon thereafter.”
ALS is marked by the <a href="https://alsnewstoday.com/symptoms-of-als/">progressive damage and death of motor neurons</a>, the nerve cells that control voluntary movements. With the loss of these neurons, the brain becomes less and less able to control muscle movement.
COYA 302 is a combination of the immune signaling molecule interleukin-2 (IL-2) and a fusion protein named CTLA4-Ig or abatacept. It is administered via a subcutaneous (under-the-skin) injection.
[recommended-reading id=85814]
<h3>Reducing inflammation, decreasing activity of damaging immune cells</h3>
The low-dose IL-2 in the combination is intended to reduce inflammation by increasing the activity of anti-inflammatory immune cells called regulatory T-cells (Tregs). CTLA4-Ig, in turn, is designed to decrease the activity of immune cells that promote inflammation and damage in ALS.
The therapy was tested in a small proof-of-concept trial involving four people with ALS. Participants were treated with COYA 302 for 48 weeks and were followed for eight more weeks after stopping the medication.
Results showed that COYA 302 resulted in a <a href="https://alsnewstoday.com/news/mda-2023-coya-302-therapy-slows-als-progression-early-trial/">considerable slowing of disease progression</a>. While participants were losing about 1.1 points per month in the ALS Functional Rating Scale (ALSFRS-R) — a measure of functional ability — before starting on COYA 302, they lost an average of 1.5 points in the whole trial duration.
However, once patients stopped the treatment, disease progression rates went back to those observed before treatment.
Analysis of immune cell function showed similar findings, with Treg activity increasing during treatment as expected, but decreasing once patients stopped treatment. Other markers of inflammation and oxidative stress, a type of cell damage associated with inflammation, also decreased with COYA 302.
The therapy was generally well tolerated, with no serious side effects described. The most common side effects were injection site reactions, which were mostly mild in severity.
Coya now expects to release data from biomarker analyses, and also publish full results from the trial in a peer-reviewed journal, before year&#8217;s end.

Coya to meet with FDA about a Phase 2 trial of COYA 302 for ALS

Four people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) each experienced a marked slowing in disease progression with COYA 302, an experimental immune-modulating therapy tested in a small proof-of-concept clinical trial, according to <a href="https://www.coyatherapeutics.com/">Coya Therapeutics</a>, its developer.
Based on these findings, Coya is planning to start work on further trials to test the therapy candidate in larger groups of ALS patients. Pending regulatory approvals, the company hopes to begin Phase 1b/2 clinical testing later this year or early next year.
&#8220;We believe the results of this initial proof-of-concept study in a small number of ALS patients are encouraging and warrant conducting a larger and controlled industry-sponsored study,&#8221; Adrian Hepner, MD, chief medical officer of Coya, said in a <a href="https://www.businesswire.com/news/home/20230321005042/en/Coya-Therapeutics-Inc.-Announces-Positive-Results-from-a-Proof-of-Concept-Academic-Clinical-Study-for-COYA-302-in-Amyotrophic-Lateral-Sclerosis-ALS">company press release</a>.
Stanley Appel, MD, chair of Coya’s scientific advisory board and a trial investigator at Houston Methodist Research Institute, in Texas, shared the study&#8217;s findings at the Muscular Dystrophy Association&#8217;s MDA Clinical &amp; Scientific Conference, held March 19-22 in Dallas. His talk was titled, &#8220;Novel Treg-modulating Immunotherapy Targets Inflammation in ALS.&#8221; The work was funded in part by Coya.
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<h3>Seeking to slow disease progression in ALS</h3>
COYA 302 contains a combination of the immune signaling molecule IL-2 and a fusion protein known as CTLA4-Ig or abatacept. It is administered via subcutaneous (under-the-skin) injection.
The therapy is designed to reduce inflammation by increasing the activity of regulatory T-cells — a type of anti-inflammatory immune cells known as Tregs — while simultaneously decreasing the activity of pro-inflammatory immune cells
Inflammation in the nervous system, termed neuroinflammation, is &#8220;an extremely important part in propagating neuronal injury in ALS,&#8221; Appel said.
Coya recently forged an agreement with a global pharmaceutical company known as Dr. Reddy’s Laboratories for the production of COYA 302. Under the agreement, Coya will produce the IL-2 component of the therapy — which the company is also developing separately under the name COYA 301 — while Dr. Reddy&#8217;s will provide the CTLA4-Ig part of COYA 302.
&#8220;We believe that the combined resources of both organizations strengthens our chances to bring this therapeutic modality to patients with neurodegenerative diseases if approved by regulatory authorities,&#8221; Howard Berman, PhD, Coya&#8217;s CEO, said in a <a href="https://www.businesswire.com/news/home/20230317005028/en/Coya-Therapeutics-Inc.-Announces-an-Agreement-with-Dr.-Reddy%E2%80%99s-Laboratories-Ltd.-to-License-its-proposed-biosimilar-Abatacept-for-the-Development-and-Commercialization-of-COYA-302-for-the-Treatment-of-Neurodegenerative-Diseases">press release</a> announcing the agreement.
In the proof-of-concept clinical trial, four ALS patients were treated with COYA 302 for 48 weeks, or about one year. The participants then were followed for an additional eight weeks (about two months) after they stopped receiving the medication.
The therapy was generally well tolerated, with no serious side effects reported. The most common side effects were injection site reactions that were mostly rated as mild.
&#8220;Safety and tolerability went very very well in these patients,&#8221; Appel said, noting that the injection reactions seen were similar to reactions that are common with other injectable therapies like insulin.
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<h3>ALS progression slowed, ALSFRS-R scores show</h3>
The participants&#8217; symptom severity and functional abilities were measured with the ALS Functional Rating Scale (ALSFRS-R), in which higher scores indicate a better ability to function. Prior to starting the study, the participants&#8217; ALSFRS-R scores were decreasing at a rate of about 1.1 points per month on average.
At the start of the study (baseline), the average ALSFRS-R score was 33.5 points. Halfway through the study, at week 24, the average score was stable at 33.75 points. After 48 weeks of treatment, the average score had declined less than two points to 32. The difference in scores from the start of the trial to its end was not statistically significant.
These results indicate that ALS progression was slowed considerably while patients were receiving treatment with COYA 302. However, after treatment with COYA 302 stopped, patients showed rates of disease progression resembling those before treatment, going from 32 points in the ALSFRS-R scale to 30 in about eight weeks.
&#8220;The average patient decline, as measured by ALSFRS-R, is approximately -1-point/month. In the present study there was no average decline from baseline to 24 weeks and we observed minimal average decline from baseline to 48 weeks,&#8221; Appel said.
&#8220;To us, this was truly exciting to go 48 weeks and have the patients doing as well as they were, with good safety and good tolerability,&#8221; he said.
[quote align=&#8221;center&#8221;]We believe the results of this initial proof-of-concept study in a small number of ALS patients are encouraging and warrant conducting a larger and controlled industry-sponsored study.[/quote]
Analyses of immune cell function indicated that the therapy was working as designed: data suggested that Treg activity increased during the 48 weeks of treatment with COYA 302, then decreased again once patients were off the therapy. Other markers of inflammation and oxidative stress — a type of cell damage associated with inflammation — also decreased with COYA 302 treatment.
&#8220;The therapy was well tolerated, and most significantly it enhanced [Treg] suppressive functions, suppressed markers of oxidative stress, and ameliorated disease progression over 48 weeks,&#8221; Appel said. He added that these findings suggest COYA 302 &#8220;may provide a potentially meaningful approach for the &#8216;unmet need&#8217; in ALS.&#8221;
Appel stressed that further studies will be needed to conclusively evaluate the efficacy of COYA 302.
But he added, &#8220;We&#8217;re very excited about where we are as the preliminary proof of concept.&#8221;
Coya also is developing a cell therapy called COYA 101, in which Treg cells are administered as a form of treatment. Data from early trials of that therapy also have suggested <a href="https://alsnewstoday.com/news/coya-treg-therapy-als001-als-reduces-inflammation-early-trial/">reductions in oxidative stress</a> and <a href="https://alsnewstoday.com/news/treg-therapy-found-safe-effective-slowing-als-small-trial/">slower ALS disease progression</a>.

Tag: COYA 302

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